By Jon Dellaquila, CIS Senior Compliance Associate
jondellaquila@cis-partners.com
Recently the Food and Drug Administration (FDA) received several recommendations from its advisory committee regarding the use of acetaminophen, due to the drug’s ability to potentially cause liver failure. The suggestions offered by the advisory committee include lowering dosage amounts, removing acetaminophen from products that contain other medications, and requiring a black box warning.[1] The scope of this decision and its effect on the general public may be surprisingly large. The products affected include the popular pain killers Tylenol and Excedrin, as well as a variety of cold medicines. Although the FDA does not have to follow the advisory committee’s recommendations, it consistently does. The FDA will more than likely implement a few changes regarding the consumer’s ability to obtain products containing acetaminophen in order to promote safety. However, these products, and the FDA’s regulation of them, may not be the true problem.
The FDA is limited in its ability to inform consumers about the use of any medications, food or drink they choose to consume. It does have the ability to approve and remove products from market, limit the dosage amounts of medications, and require package inserts to be included with them in the hopes of keeping patients informed. However, once the products hit the market shelves and are available over the counter or as prescribed by a physician, the consumers become responsible for their own well being. Patient responsibility may be the root of the acetaminophen issue. The FDA can require acetaminophen doses be lowered from 500 mg to 325 mg in a single pill, and the maximum daily doses be lowered from 4,000 mg to 2,600 mg, but that cannot prevent someone from ingesting more pills to reach the 4,000 mg level if they choose to do so.[2] Regardless of the dosage of acetaminophen contained in any product, the patient will still have the ability to overdose on the medication.
The black box warning for products containing acetaminophen may be the most effective tool in alerting patients that there is concern about their safety when taking any of these medications. It is also possible that the FDA will begin requiring the sale of acetaminophen products behind the counter, as was done with medicines containing pseudoephedrine due to the Combat Methamphetamine Epidemic Act of 2005.[3] Although these two drugs would be sold behind the counter for different reasons, doing so would provide one additional opportunity for the patient to be informed by a pharmacist about the use of acetaminophen.
The FDA does an admirable job of ensuring patient safety, but its power is limited. The ultimate responsibility lies with the consumer. People need to be aware that anything they choose to ingest will impact their health and their body in one way or another. Consumers should do their best to stay well informed, and be aware of what they eat and what medicines they take. So, as a consumer and concerned citizen, please remember to be aware of any medications you may be taking, as well as their dosages. When in doubt, do not hesitate to call your physician or speak to a pharmacist prior to taking any medication.
Sources:
[1]Foxhall, Kathryn. “FDA May Restrict Acetaminophen.” WebMD. 01 Jul 2009. Accessed: 13 Jul 2009.
http://www.webmd.com/pain-management/news/20090701/fda-may-restrict-acetaminophen?page=2
[2]Beck, Melinda. “Taking Pains With a Painkiller.” Wall Street Journal. 10 Jul 2009. Accessed: 13 Jul 2009.
http://online.wsj.com/article/SB10001424052970203577304574272292331942618.html?mod=googlenews_wsj
[3] Legal Requirements for the Sale and Purchase of Drug Products Containing Pseudoephedrine, Ephedrine, and Phenylpropanolamine. Food and Drug Administration. 25 Apr 2006. Accessed: 13 Jul 2009
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm072423.htm
Thursday, July 30, 2009
Wednesday, July 29, 2009
FDA Orders Stronger Warning Placed on Labels of Drugs Containing Propoxyphene
By: Kerri McCutchin, CIS Compliance Associate
kerrimccutchin@cis-partners.com
The Food and Drug Administration (FDA) has recently ordered manufacturers to place stronger warning labels on the prescription pain killer propoxyphene, commonly known as Darvon or Darvocet. Action has been taken due evidence of fatal overdoses, both accidental and intentional, involving propoxyphene. In Europe, recent data indicates that this medication could possbily be more lethal in overdose than other pain medications [5]. Propoxyphene has been on the market since 1957, and is an opiate commonly prescribed to relieve mild to moderate pain [4]. The most frequent side effects of propoxyphene include lightheadedness, dizziness, sedation, nausea, and vomiting [3].
Despite lobbying intended to eliminate propoxyphene from the market, the FDA has concluded at this time that the benefits of propoxyphene for pain relief at recommended doses outweigh the safety risks. Thus, the FDA is not suggesting the removal of propoxyphene products from the U.S. market [5]. Instead, the FDA will require manufacturers of propoxyphene to strengthen their labels by placing a boxed warning on each package, emphasizing the possible risks. Manufacturers are also required to provide consumers with a medication guide, highlighting the importance of using the drug as directed [2]. Furthermore, the FDA has required manufacturers to study higher than expected fatality rates in propoxyphene overdoses, versus those caused by other painkillers, as well as possible toxic effects on the heart when consumers exceed recommended doses [3].
More specifically, the following studies are in the planning process:
Lastly, the FDA noted that it also plans to continue to evaluate the safety of propoxyphene and will take additional and immediate regulatory action if necessary [4].
Sources
[1] http://www.rxlist.com/darvon-drug.htm
[2] http://www.consumeraffairs.com/news04/2009/07/fda_darvon.html
[3] http://abcnews.go.com/Health/PainManagement/Story?id=8027102&page=1
[4] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170769.htm
[5] http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm170268.htm
kerrimccutchin@cis-partners.com
The Food and Drug Administration (FDA) has recently ordered manufacturers to place stronger warning labels on the prescription pain killer propoxyphene, commonly known as Darvon or Darvocet. Action has been taken due evidence of fatal overdoses, both accidental and intentional, involving propoxyphene. In Europe, recent data indicates that this medication could possbily be more lethal in overdose than other pain medications [5]. Propoxyphene has been on the market since 1957, and is an opiate commonly prescribed to relieve mild to moderate pain [4]. The most frequent side effects of propoxyphene include lightheadedness, dizziness, sedation, nausea, and vomiting [3].
Despite lobbying intended to eliminate propoxyphene from the market, the FDA has concluded at this time that the benefits of propoxyphene for pain relief at recommended doses outweigh the safety risks. Thus, the FDA is not suggesting the removal of propoxyphene products from the U.S. market [5]. Instead, the FDA will require manufacturers of propoxyphene to strengthen their labels by placing a boxed warning on each package, emphasizing the possible risks. Manufacturers are also required to provide consumers with a medication guide, highlighting the importance of using the drug as directed [2]. Furthermore, the FDA has required manufacturers to study higher than expected fatality rates in propoxyphene overdoses, versus those caused by other painkillers, as well as possible toxic effects on the heart when consumers exceed recommended doses [3].
More specifically, the following studies are in the planning process:
- The FDA is working with CMS to study the safety and prescribing patterns of propoxyphene among the elderly. Notably, the FDA will look at the rates of fatalities and hip fractures among elderly patients taking propoxyphene, and compare these rates to those in elderly persons taking other analgesics.
- The FDA plans to discuss a study examining the safety of propoxyphene with the Veterans Administration, using the VA's databases.
- The FDA is planning to examine the safety of propoxyphene with one or more of its epidemiology contractors (Vanderbilt University, Kaiser - California, the HMO Research Network at Harvard Pilgrim Health, and Ingenix).
- Lastly, the FDA will examine the possibility of reviewing Medical Examiner data in the Substance Abuse and Mental Health Administration’s (SAMSHA) Drug Abuse Warning Network (DAWN) [5].
“Physicians need to be aware of the risk of overdose when prescribing these
drugs. They should carefully review patient histories and make appropriate
treatment decisions based on the warnings and directions stated within the
drug’s label. Prescribers and patients should be aware of propoxyphene’s
potential risks when used at doses higher than those recommended. Therefore, the
FDA is requiring manufacturers to provide more information to help physicians
and patients decide whether propoxyphene is the appropriate pain therapy.” [4]
Lastly, the FDA noted that it also plans to continue to evaluate the safety of propoxyphene and will take additional and immediate regulatory action if necessary [4].
Sources
[1] http://www.rxlist.com/darvon-drug.htm
[2] http://www.consumeraffairs.com/news04/2009/07/fda_darvon.html
[3] http://abcnews.go.com/Health/PainManagement/Story?id=8027102&page=1
[4] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170769.htm
[5] http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm170268.htm
Tuesday, July 28, 2009
This Year's Flu Vaccines
By: Suzanne Tavares, CIS Compliance Director
suzannetavares@cis-partners.com
This year, flu season will be a different event. It is the first time in history that officials will be recommending two different flu vaccines, both available on different schedules. One vaccine will be for the H1N1 “swine flu” virus, and the second will be for the seasonal flu. The H1N1 virus was declared a pandemic on June 11 of this year. It closed hundreds of schools across the country. Barbara Ferrer, executive direct of the Boston Public Health Commission, said one in every 10 Boston school children were affected by the H1N1 virus.
Health officials predict that swine flu season will begin earlier than the traditional flu season. They expect H1N1 to break out in September instead of the regular October/November timeframe. Even though it is summer and the traditional flu season has ended, swine flu is still around in the US, especially in summer camps. “We expect challenges when people return to school, when kids are congregating together,” Dr. Anne Schuchat, director of respiratory diseases at the Centers for Disease Control and Prevention, stated in a telephone news conference last week. The goal of public health officials is to develop and administer the swine vaccine early, especially to school age children. This group and the elderly are particularly susceptible to this strain.
However, manufacturing the swine flu vaccine has its challenges, and the clock is ticking. The government shipped the H1N1 seed strain to vaccine manufactures in May. The H1N1 flu strain is growing between 25-50% slower than the seasonal H1N1 flu strain, but manufacturers are trying different methods to speed up the growth. Last week, Australia initiated clinical trials for the vaccine; in the US, the FDA will have only weeks to decide if the vaccine is safe.
What can you do to stay healthy as we wait for these vaccines? The CDC has published the following recommendations:
http://www.cdc.gov/h1n1flu/
http://www.nytimes.com/2009/07/18/health/18flu.html
http://www.npr.org/templates/story/story.php?storyId=106848740
http://www.npr.org/templates/story/story.php?storyId=106662735
suzannetavares@cis-partners.com
This year, flu season will be a different event. It is the first time in history that officials will be recommending two different flu vaccines, both available on different schedules. One vaccine will be for the H1N1 “swine flu” virus, and the second will be for the seasonal flu. The H1N1 virus was declared a pandemic on June 11 of this year. It closed hundreds of schools across the country. Barbara Ferrer, executive direct of the Boston Public Health Commission, said one in every 10 Boston school children were affected by the H1N1 virus.
Health officials predict that swine flu season will begin earlier than the traditional flu season. They expect H1N1 to break out in September instead of the regular October/November timeframe. Even though it is summer and the traditional flu season has ended, swine flu is still around in the US, especially in summer camps. “We expect challenges when people return to school, when kids are congregating together,” Dr. Anne Schuchat, director of respiratory diseases at the Centers for Disease Control and Prevention, stated in a telephone news conference last week. The goal of public health officials is to develop and administer the swine vaccine early, especially to school age children. This group and the elderly are particularly susceptible to this strain.
However, manufacturing the swine flu vaccine has its challenges, and the clock is ticking. The government shipped the H1N1 seed strain to vaccine manufactures in May. The H1N1 flu strain is growing between 25-50% slower than the seasonal H1N1 flu strain, but manufacturers are trying different methods to speed up the growth. Last week, Australia initiated clinical trials for the vaccine; in the US, the FDA will have only weeks to decide if the vaccine is safe.
What can you do to stay healthy as we wait for these vaccines? The CDC has published the following recommendations:
- Stay informed. The CDC Website is updated as information becomes available.
- Cover your nose and mouth with a tissue when you need to cough or sneeze, and throw the tissue in the trash after you use it. (The flu is spread mainly from person to person through the coughing or sneezing of infected people.)
- Wash your hands with soap and water.
- Avoid touching your eyes, nose or mouth, which spreads germs.
- Stay home from school or work if you are sick, and limit your contact with others.
- Follow public health advice on school closures, and avoid crowds.
- Find healthy ways to deal with stress.
http://www.cdc.gov/h1n1flu/
http://www.nytimes.com/2009/07/18/health/18flu.html
http://www.npr.org/templates/story/story.php?storyId=106848740
http://www.npr.org/templates/story/story.php?storyId=106662735
Monday, July 27, 2009
The Cost of Non-Compliance within the Pharmaceutical Industry
By: Karen Brown, Senior Director, Marketing
karenbrown@cis-partners.com
In a time when congress is seeking more scrutiny through stringent audits of its own government bail-out programs, words like transparency and accountability are becoming colloquial favorites of corporate leadership.
One example is a recent full page letter that GM has placed in papers around the globe, promising customers that they are making fundamental changes from top to bottom. The letter went on to provide a website to track their progress on this commitment.[1]
When we think about a similar strategy for the pharmaceutical industry, we need to pause and consider all of the areas that are impacted: patient, shareholder, community, organization, and determine whether the solution lies in corporate candor or in fundamental changes – top to bottom.
Let’s start by examining two areas where non-compliance has the most impact:
First, there is patient non-compliance. where it is estimated that 70% of all prescriptions are never consumed and 20% of all new drug prescriptions are never filled the first time. This costs US Pharma nearly $30 billion a year in lost revenue. And, most serious, the loss of 125,000 lives each year.[2]
Second, achieving regulatory compliance is crucial and costly; non-compliance can lead to imprisonment, large fines, product recalls or delays in product approval, reputational harm and plant shutdowns.
One extreme example is a large pharmaceutical manufacturer that recently paid nearly $1.5 billion in fines for marketing one of its drugs for uses not approved by the FDA; the Justice Department called this the "largest criminal fine for an individual corporation ever imposed in the United States.”[3]
So what do we really know about the cost of non-compliance, and where does pharma begin to address these issues? One approach may be to start seeking answers to some serious compliance questions:
Having a corporate compliance office or implementing one may not solve the issues surrounding patient medication compliance, but it’s a start by showing corporate responsibility, visibility and accountability.
Perhaps GM is on to something. We may see the demise of some historic auto brands, but if they hold true to their commitment to not just rebuild the company, but to reinvent it, we may see an industry that is smarter, leaner, faster and more focused on the customer.
Sources:
1. The Financial Times, June 5 2009 http://www.ft.com/home/us
2. http://social.eyeforpharma.com/story/real-cost-patient-non-adherence
3. http://money.cnn.com/2009/01/15/news/companies/eli_lilly/
4. http://www.medicalnewstoday.com/articles/127236.php
karenbrown@cis-partners.com
In a time when congress is seeking more scrutiny through stringent audits of its own government bail-out programs, words like transparency and accountability are becoming colloquial favorites of corporate leadership.
One example is a recent full page letter that GM has placed in papers around the globe, promising customers that they are making fundamental changes from top to bottom. The letter went on to provide a website to track their progress on this commitment.[1]
When we think about a similar strategy for the pharmaceutical industry, we need to pause and consider all of the areas that are impacted: patient, shareholder, community, organization, and determine whether the solution lies in corporate candor or in fundamental changes – top to bottom.
Let’s start by examining two areas where non-compliance has the most impact:
First, there is patient non-compliance. where it is estimated that 70% of all prescriptions are never consumed and 20% of all new drug prescriptions are never filled the first time. This costs US Pharma nearly $30 billion a year in lost revenue. And, most serious, the loss of 125,000 lives each year.[2]
Second, achieving regulatory compliance is crucial and costly; non-compliance can lead to imprisonment, large fines, product recalls or delays in product approval, reputational harm and plant shutdowns.
One extreme example is a large pharmaceutical manufacturer that recently paid nearly $1.5 billion in fines for marketing one of its drugs for uses not approved by the FDA; the Justice Department called this the "largest criminal fine for an individual corporation ever imposed in the United States.”[3]
So what do we really know about the cost of non-compliance, and where does pharma begin to address these issues? One approach may be to start seeking answers to some serious compliance questions:
- Do we know what our total cost of compliance is?
- Do we understand where we may be exposed to non-compliance risks, and at what level?
- Do we have the visibility to see how one compliance issue impacts another?
- Do we have the infrastructure to manage a corporate compliance department across the organization?
Having a corporate compliance office or implementing one may not solve the issues surrounding patient medication compliance, but it’s a start by showing corporate responsibility, visibility and accountability.
Perhaps GM is on to something. We may see the demise of some historic auto brands, but if they hold true to their commitment to not just rebuild the company, but to reinvent it, we may see an industry that is smarter, leaner, faster and more focused on the customer.
Sources:
1. The Financial Times, June 5 2009 http://www.ft.com/home/us
2. http://social.eyeforpharma.com/story/real-cost-patient-non-adherence
3. http://money.cnn.com/2009/01/15/news/companies/eli_lilly/
4. http://www.medicalnewstoday.com/articles/127236.php
Thursday, July 23, 2009
Not What the Doctor Ordered
By: Aimee Hummel, CIS Compliance Manager
aimeehummel@cis-partners.com
With today’s rising healthcare costs, the use of generic drugs has increased dramatically. This is mainly due to the significant cost savings of using generics; for some consumers it can add up to savings of $1,000 a year. Over the last 10 years, generics have saved consumers $734 billion nationwide, according to a report issued in May by the Generic Pharmaceutical Association. [i]
Although the savings are a substantial benefit, there are certain practices being adopted by insurance and prescription drug companies that have demonstrated serious risks. These practices are known as generic and therapeutic substitution, or switching, both of which may cause dangerous health risks and have caused a serious debate in the healthcare industry. Generic substitution is the practice of switching a brand name medication with another medication that is bioequivalent. Therapeutic substitution involves replacing your prescription medication with a different medication – which is often chemically different but expected to have the same clinical effect. [ii]
The problems related to these practices have occurred due to the fact that even though the substituted drugs are considered very similar, they may not be as effective, can have new or different side effects, and may have dangerous interactions with other medications, supplements or food. And making matters worse, the fact that the doctors who prescribe the medicines are not informed of the substitution, increases the risks.
The article referenced below tells a story where a child was given a generic drug used to treat epilepsy even though her doctor wrote “Dispense as Written” on the script. The medication she was initially prescribed had been effectively controlling her seizures. However, after switching to the generic medication, the child suffered 21 seizures that week. [i]
http://www.freep.com/article/20090608/BUSINESS06/906080329/
Since the cost savings show such a huge benefit, yet the risks cause serious concern, it is evident why this has become a heated debate. It seems to me that the best way to remedy the potential risk is to have rules and regulations around drug substitution. Several states have bills in their legislatures, yet no laws have been passed. If there were regulations that required the prescribing doctor’s consent before any changes were made, the potential risk would decrease.
Drug substitution doesn’t necessarily lead to negative outcomes like side effects, decreased efficacy, or dangerous interactions with other substances. “In fact, it is possible that switching to a new medication can result in fewer side effects, better efficacy, and lower costs,” says Sally Greenburg, executive director for the National Consumers League.” [ii]
Consumers must be conscious of their prescriptions and be careful when they are given a substitution. I believe we should have a say in our own healthcare and we must be aware of potential risks.
A helpful resource regarding Drug Substitution information and recommendations by The World Medical Association can be found at the following site: http://www.wma.net/e/policy/d13.htm [iii]
Sources:
[i] http://www.freep.com/article/20090608/BUSINESS06/906080329/
[ii] http://www.sheknows.com/articles/806389.htm
[iii] http://www.wma.net/e/policy/d13.htm
[iv] http://www.ncbi.nlm.nih.gov/pubmed/3731208
[v] http://www.therightprescription.org/site/second/drug_debate
[vi] http://www.epilepsymichigan.org/template.php?pid=96
aimeehummel@cis-partners.com
With today’s rising healthcare costs, the use of generic drugs has increased dramatically. This is mainly due to the significant cost savings of using generics; for some consumers it can add up to savings of $1,000 a year. Over the last 10 years, generics have saved consumers $734 billion nationwide, according to a report issued in May by the Generic Pharmaceutical Association. [i]
Although the savings are a substantial benefit, there are certain practices being adopted by insurance and prescription drug companies that have demonstrated serious risks. These practices are known as generic and therapeutic substitution, or switching, both of which may cause dangerous health risks and have caused a serious debate in the healthcare industry. Generic substitution is the practice of switching a brand name medication with another medication that is bioequivalent. Therapeutic substitution involves replacing your prescription medication with a different medication – which is often chemically different but expected to have the same clinical effect. [ii]
The problems related to these practices have occurred due to the fact that even though the substituted drugs are considered very similar, they may not be as effective, can have new or different side effects, and may have dangerous interactions with other medications, supplements or food. And making matters worse, the fact that the doctors who prescribe the medicines are not informed of the substitution, increases the risks.
The article referenced below tells a story where a child was given a generic drug used to treat epilepsy even though her doctor wrote “Dispense as Written” on the script. The medication she was initially prescribed had been effectively controlling her seizures. However, after switching to the generic medication, the child suffered 21 seizures that week. [i]
http://www.freep.com/article/20090608/BUSINESS06/906080329/
Since the cost savings show such a huge benefit, yet the risks cause serious concern, it is evident why this has become a heated debate. It seems to me that the best way to remedy the potential risk is to have rules and regulations around drug substitution. Several states have bills in their legislatures, yet no laws have been passed. If there were regulations that required the prescribing doctor’s consent before any changes were made, the potential risk would decrease.
Drug substitution doesn’t necessarily lead to negative outcomes like side effects, decreased efficacy, or dangerous interactions with other substances. “In fact, it is possible that switching to a new medication can result in fewer side effects, better efficacy, and lower costs,” says Sally Greenburg, executive director for the National Consumers League.” [ii]
Consumers must be conscious of their prescriptions and be careful when they are given a substitution. I believe we should have a say in our own healthcare and we must be aware of potential risks.
A helpful resource regarding Drug Substitution information and recommendations by The World Medical Association can be found at the following site: http://www.wma.net/e/policy/d13.htm [iii]
Sources:
[i] http://www.freep.com/article/20090608/BUSINESS06/906080329/
[ii] http://www.sheknows.com/articles/806389.htm
[iii] http://www.wma.net/e/policy/d13.htm
[iv] http://www.ncbi.nlm.nih.gov/pubmed/3731208
[v] http://www.therightprescription.org/site/second/drug_debate
[vi] http://www.epilepsymichigan.org/template.php?pid=96
Wednesday, July 22, 2009
Paging Dr. iPhone
By: Chris Didizian, CIS Senior Associate
chrisdidizian@cis-partners.com
Skimming through the Pharma news, as I tend to do early in the morning, I stumbled on an article that linked the pharma industry with the iPhone. Being somewhat of a technology geek, I read on. With Apple’s recent release of its new generation iPhone 3G(S), a powerful tool capable of managing any of roughly 35,000 applications (apps), the possibilities are endless. In fact, users will soon be able to track vital signs, blood pressure, and glucose levels through their iPhones.[1] Through presentations and marketing, Apple has made it very obvious that it will help incorporate medical information and devices with consumer electronics (the iPhone). It follows that if drugmakers were to fully utilize a popular device like the iPhone, then naturally it would extend their marketing efforts into this realm.
Currently, there exist “more than 500 medical apps, mainly used by health professionals for things such as checking normal lab values, which allow interpretation of test results… and looking up definitions of medical terms.”[2] Looking at this quotation with the “big picture viewpoint,” it would be easy to make the assumption that it’s only a matter of time before drugmakers develop an app that can suggest drugs based on specific symptoms or direct users to certain physicians within their area. If my assumption is not convincing enough, then take into consideration that one drugmaker is currently developing an app to act as a glucometer – Apple sees this example as an opportunity to further expand into the vast medical field.[3] Of course, this app is one you must pay for. How long before the iPhone can measure cholesterol, or even begin to diagnose diseases based on symptoms input by the user?
Moving forward it will be interesting to see what guidelines the FDA will publish regarding these apps, but I wouldn’t hold my breath (just last month an overdue guidance regarding risk information in promotional materials was posted). Until then, it can be expected that any instruction on the appropriate use of these apps will need to be extrapolated from untitled and warning letters.
Sources:
[1] http://www.ihe-online.com/index.php?id=2565&tx_ttnews%5Btt_news%5D=483&cHash=65536
[2] Ibid.
[3] Ibid.
chrisdidizian@cis-partners.com
Skimming through the Pharma news, as I tend to do early in the morning, I stumbled on an article that linked the pharma industry with the iPhone. Being somewhat of a technology geek, I read on. With Apple’s recent release of its new generation iPhone 3G(S), a powerful tool capable of managing any of roughly 35,000 applications (apps), the possibilities are endless. In fact, users will soon be able to track vital signs, blood pressure, and glucose levels through their iPhones.[1] Through presentations and marketing, Apple has made it very obvious that it will help incorporate medical information and devices with consumer electronics (the iPhone). It follows that if drugmakers were to fully utilize a popular device like the iPhone, then naturally it would extend their marketing efforts into this realm.
Currently, there exist “more than 500 medical apps, mainly used by health professionals for things such as checking normal lab values, which allow interpretation of test results… and looking up definitions of medical terms.”[2] Looking at this quotation with the “big picture viewpoint,” it would be easy to make the assumption that it’s only a matter of time before drugmakers develop an app that can suggest drugs based on specific symptoms or direct users to certain physicians within their area. If my assumption is not convincing enough, then take into consideration that one drugmaker is currently developing an app to act as a glucometer – Apple sees this example as an opportunity to further expand into the vast medical field.[3] Of course, this app is one you must pay for. How long before the iPhone can measure cholesterol, or even begin to diagnose diseases based on symptoms input by the user?
Moving forward it will be interesting to see what guidelines the FDA will publish regarding these apps, but I wouldn’t hold my breath (just last month an overdue guidance regarding risk information in promotional materials was posted). Until then, it can be expected that any instruction on the appropriate use of these apps will need to be extrapolated from untitled and warning letters.
Sources:
[1] http://www.ihe-online.com/index.php?id=2565&tx_ttnews%5Btt_news%5D=483&cHash=65536
[2] Ibid.
[3] Ibid.
Monday, July 20, 2009
The Affordable Healthcare Choices Act
By: Scott Hoffman, CIS Senior Associate
scotthoffman@cis-partners.com
On June 9, 2009 a draft copy of the Affordable Healthcare Choices Act (the Act) was released. The Act was created by Senator Edward Kennedy and the Senate Committee on Health, Education, Labor and Pensions [1]. The five major elements of the Act are as follows:
Choice: An important foundation of the Act is the principle that if you are content with the coverage you currently have, you keep it. If you don't have health insurance or don't like the insurance you currently have, the Act will give you new, more affordable options.
Cost Reduction: The Act aims to reduce current healthcare costs through stronger prevention, better quality of care and the use of information technology. It will also attempt to root out fraud and abuse, and reduce unnecessary procedures.
Prevention: The best way to treat a disease is to prevent it from ever striking, which is exactly why the Act will give citizens the information they need to take charge of their own health. The bill will make information widely available in medical settings such as schools and communities. It will also promote early screening for heart disease, cancer and depression, while providing citizens with more information on healthy nutrition and the dangers of smoking.
Health System Modernization: The Act will take strong steps to see that America has a 21st-century workforce for a modern and responsive healthcare system. It emphasizes sound investments in training the doctors, nurses, and other health professionals who will serve the needs of patients in future years.
Long Term Care and Services: The Act will also help make it possible for the elderly and disabled to live at home and function independently. It would assist them in having wheelchair accessible ramps installed in their homes, hiring a care worker to check in on them regularly, and provide an array of other support fucntions to enable them to stay in their communities instead of moving to nursing homes [2].
At this point in time the Act is only a preliminary draft, and will almost assuredly undergo significant changes before it heads to Congress. The main concern expressed over the Act revolves around how to pay for the proposed system overhaul. Early estimates by the Congressional Budget Office (CBO) priced the plan at approximately $1.6 trillion over 10 years, while only covering a third of Americans currently without healthcare [3]. The CBO estimate is a major concern to both Democrats and Republicans, considering there has been no clear cut method identified on how the overhaul will be financed.
Recently, Senate Finance Committee Chairman Max Baucus suggested a cost cutting plan for the current Medicare program as one potential method; but there are concerns among the public and CBO regarding the Baucus proposal [3]. The public concern centers around the impact that Medicare cuts would impose on their current costs; the CBO is concerned that these proposed cuts would not take place, as Congress has been very hesitant to cut Medicare benefits in the past [3].
Another method was recently implied by President Barack Obama in his announcement of a pact with industry manufactures that would result in approximately $80 billion in savings for Medicare Part D prescriptions, as well as contributions to the health plan overhaul. The only concern is the fact that there was no specific amount attributed to the system overhaul [4]. While these are only two possible methods of paying for the proposal, they illustrate the point that any system overhaul is going to result in significant changes, and costs, to a variety of individuals, from the individual taxpayer all the way to industry manufacturers. With the House set to release its proposal in the very near future, you can expect to hear more about the Affordable Healthcare Choices Act.
Sources:
[1] http://www.opencongress.org/articles/view/1033-Affordable-Health-Choices-Act
[2] http://www.simplifymd.com/wp-content/uploads/2009/06/2009_06_09.pdf
[3] http://online.wsj.com/article/SB124537120871529803.html
[4] http://online.wsj.com/article/SB124567211118336815.html
scotthoffman@cis-partners.com
On June 9, 2009 a draft copy of the Affordable Healthcare Choices Act (the Act) was released. The Act was created by Senator Edward Kennedy and the Senate Committee on Health, Education, Labor and Pensions [1]. The five major elements of the Act are as follows:
Choice: An important foundation of the Act is the principle that if you are content with the coverage you currently have, you keep it. If you don't have health insurance or don't like the insurance you currently have, the Act will give you new, more affordable options.
Cost Reduction: The Act aims to reduce current healthcare costs through stronger prevention, better quality of care and the use of information technology. It will also attempt to root out fraud and abuse, and reduce unnecessary procedures.
Prevention: The best way to treat a disease is to prevent it from ever striking, which is exactly why the Act will give citizens the information they need to take charge of their own health. The bill will make information widely available in medical settings such as schools and communities. It will also promote early screening for heart disease, cancer and depression, while providing citizens with more information on healthy nutrition and the dangers of smoking.
Health System Modernization: The Act will take strong steps to see that America has a 21st-century workforce for a modern and responsive healthcare system. It emphasizes sound investments in training the doctors, nurses, and other health professionals who will serve the needs of patients in future years.
Long Term Care and Services: The Act will also help make it possible for the elderly and disabled to live at home and function independently. It would assist them in having wheelchair accessible ramps installed in their homes, hiring a care worker to check in on them regularly, and provide an array of other support fucntions to enable them to stay in their communities instead of moving to nursing homes [2].
At this point in time the Act is only a preliminary draft, and will almost assuredly undergo significant changes before it heads to Congress. The main concern expressed over the Act revolves around how to pay for the proposed system overhaul. Early estimates by the Congressional Budget Office (CBO) priced the plan at approximately $1.6 trillion over 10 years, while only covering a third of Americans currently without healthcare [3]. The CBO estimate is a major concern to both Democrats and Republicans, considering there has been no clear cut method identified on how the overhaul will be financed.
Recently, Senate Finance Committee Chairman Max Baucus suggested a cost cutting plan for the current Medicare program as one potential method; but there are concerns among the public and CBO regarding the Baucus proposal [3]. The public concern centers around the impact that Medicare cuts would impose on their current costs; the CBO is concerned that these proposed cuts would not take place, as Congress has been very hesitant to cut Medicare benefits in the past [3].
Another method was recently implied by President Barack Obama in his announcement of a pact with industry manufactures that would result in approximately $80 billion in savings for Medicare Part D prescriptions, as well as contributions to the health plan overhaul. The only concern is the fact that there was no specific amount attributed to the system overhaul [4]. While these are only two possible methods of paying for the proposal, they illustrate the point that any system overhaul is going to result in significant changes, and costs, to a variety of individuals, from the individual taxpayer all the way to industry manufacturers. With the House set to release its proposal in the very near future, you can expect to hear more about the Affordable Healthcare Choices Act.
Sources:
[1] http://www.opencongress.org/articles/view/1033-Affordable-Health-Choices-Act
[2] http://www.simplifymd.com/wp-content/uploads/2009/06/2009_06_09.pdf
[3] http://online.wsj.com/article/SB124537120871529803.html
[4] http://online.wsj.com/article/SB124567211118336815.html
Friday, July 17, 2009
A Blog about a Blog
By: Karen Brown, Senior Director of Marketing
karenbrown@cis-partners.com
Thumbs up to the FDA for stepping into the 21st century social media realm for their efforts in launching the FDA Transparency Blog on June 2nd. (Apologies to those outside the U.S., where the thumbs up gesture is considered foul and pejorative.)
According to the new blog, the Administration is committed to eliminating barriers between the American people and their government.
The blog encourages readers to submit ideas and suggestions on how to improve transparency at the agency. In addition, you can submit electronic comments to the Federal Register, and, the public is encouraged to attend a meeting later this month with members of the Task Force.
So far, the blog has been met with some skepticism, receiving comments questioning the FDA’s visibility objectives: “Transparency to the American public is a fine goal and I applaud your efforts to do this in an online forum. However, the industries you regulate need the FDA to be transparent as well.”
I’d recommend giving this a little more time before we assume the thumbs down position. This could be the opportunity that the pharmaceutical industry needs to set up similar online discussions. Today, there are only a few large pharmaceutical manufacturers who regularly maintain a blog, though the number of companies using Twitter at a corporate level has grown to about 12.
You can check out the FDA’s blog at: http://fdatransparencyblog.fda.gov/2009/06/transparency-blog.html
Other Sources:
http://www.doseofdigital.com/healthcare-pharma-social-media-wiki/
GSK US Twitter
karenbrown@cis-partners.com
Thumbs up to the FDA for stepping into the 21st century social media realm for their efforts in launching the FDA Transparency Blog on June 2nd. (Apologies to those outside the U.S., where the thumbs up gesture is considered foul and pejorative.)
According to the new blog, the Administration is committed to eliminating barriers between the American people and their government.
The blog encourages readers to submit ideas and suggestions on how to improve transparency at the agency. In addition, you can submit electronic comments to the Federal Register, and, the public is encouraged to attend a meeting later this month with members of the Task Force.
So far, the blog has been met with some skepticism, receiving comments questioning the FDA’s visibility objectives: “Transparency to the American public is a fine goal and I applaud your efforts to do this in an online forum. However, the industries you regulate need the FDA to be transparent as well.”
I’d recommend giving this a little more time before we assume the thumbs down position. This could be the opportunity that the pharmaceutical industry needs to set up similar online discussions. Today, there are only a few large pharmaceutical manufacturers who regularly maintain a blog, though the number of companies using Twitter at a corporate level has grown to about 12.
You can check out the FDA’s blog at: http://fdatransparencyblog.fda.gov/2009/06/transparency-blog.html
Other Sources:
http://www.doseofdigital.com/healthcare-pharma-social-media-wiki/
GSK US Twitter
Thursday, July 16, 2009
The Quality by Design Initiative
By: Gary Miller, CIS Senior Compliance Associate
garymiller@cis-partners.com
In 2005, the Food and Drug Administration (FDA) started a pilot program to allow participating companies to submit chemistry manufacturing and controls (CMC) information demonstrating the application of Quality by Design (QbD). The drug applications to be reviewed during this pilot program are meant to provide examples of how design, space and process knowledge can be captured at an operational level, and how they can relate to normal operating ranges, equipment, and scale. [1] QbD is fundamentally built upon the theory of continuous process, which has been used in chemical manufacturing for quite some time now.
The Center for Drug Evaluation and Research (CDER) Office of New Drug Quality Assessment has stated that “the pharmaceutical industry can only realize the full benefit of QbD by developing and implementing continuous process.”[2] The FDA has a view of QbD as a “systematic approach to product and process design and development.”[3] Lawrence Yu, PhD, director for Science Office of Generic Drugs for the FDA, defines QbD as “designing and developing formulations and manufacturing processes to ensure predefined product quality. This involves the understanding of controlling formulation and manufacturing process variables affecting the quality of a drug.”[4]
In an attempt to reach this necessary understanding, the FDA has granted the National Institute of Pharmaceutical Technology and Education a $1.19 million contract. The FDA has said that “The intention of this award is the development of specifications allowing for the implementation of Quality by Design (QbD) framework to improve product quality through science and technology.”[4] The ultimate goal of this research, along with all principles of QbD, is to improve end product quality. The research is scheduled to end in September of 2010, and “the results of the study will potentially serve as the basis for formulating best practices and developing science based guidance documents that can be used by the FDA to evaluate new and generic drug applications.”[4]
Some of the key elements of QbD have already been identified. Chi-wan Chen, Deputy Director of the Office of New Drug Quality Assessment at the CDER, outlined some of the features of QbD that have already been identified in subsequent studies. The elements include:
So where does the implementation stand today? Big Pharma has been able to pursue this avenue with effectiveness, but many mid-tier Pharma companies have fallen back on old habits. It is believed in the industry that the FDA must continue to apply more pressure on the companies to change, or they will not see a need to expel the resources needed to make significant changes. Success also relies on the industry and the FDA moving toward a cohesive methodology, and sending a message explaining the need for these changes. Designing a QbD solution that is both pragmatic from a compliance standpoint, and flexible from a business perspective, will keep the pressure on industry to truly embrace the principles of QbD. [6]
Sources:
1. FDA Promotes QbD for Biotech Therapies - By Jill Wechsler, October 1, 2008
http://biopharminternational.findpharma.com/biopharm/Quality/FDA-Promotes-QbD-for-Biotech-Therapies/ArticleStandard/Article/detail/557244
2. “Quality by Design (QbD): Myth or Reality” - By Girish Malhotra, PE, President EPCOT International
http://www.pharmpro.com/ShowPR.aspx?PUBCODE=021&ACCT=0000100&ISSUE=0702&RELTYPE=PR&ORIGRELTYPE=ATO&PRODCODE=0000&PRODLETT=N&CommonCount=0
3. FDA Perspective on Quality by Design - By Patricia Van Arnum, Dec. 5 2007
http://pharmtech.findpharma.com/pharmtech/Article/A-FDA-Perspective-on-Quality-by-Design/ArticleStandard/Article/detail/469915
4. Implementation of Quality-by-Design: OGD Initiatives - By Lawrence Yu, PhD, Director for Science Office of Generic Drugs, FDA
http://www.fda.gov/ohrms/dockets/AC/06/slides/2006-4241s1_8.ppt
3. FDA Awards NIPTE $1.19 Million Contract to Develop Quality by Design (QbD) Guidance Elements - October 29, 2008
http://www.businesswire.com/portal/site/google/?ndmViewId=news_view&newsId=20081029005227&newsLang=en
6. QbD: An Interim Report Card - By Bikash Chatterjee, Pharmtech Associates, Inc.
http://www.pharmamanufacturing.com/articles/2007/158.html
garymiller@cis-partners.com
In 2005, the Food and Drug Administration (FDA) started a pilot program to allow participating companies to submit chemistry manufacturing and controls (CMC) information demonstrating the application of Quality by Design (QbD). The drug applications to be reviewed during this pilot program are meant to provide examples of how design, space and process knowledge can be captured at an operational level, and how they can relate to normal operating ranges, equipment, and scale. [1] QbD is fundamentally built upon the theory of continuous process, which has been used in chemical manufacturing for quite some time now.
The Center for Drug Evaluation and Research (CDER) Office of New Drug Quality Assessment has stated that “the pharmaceutical industry can only realize the full benefit of QbD by developing and implementing continuous process.”[2] The FDA has a view of QbD as a “systematic approach to product and process design and development.”[3] Lawrence Yu, PhD, director for Science Office of Generic Drugs for the FDA, defines QbD as “designing and developing formulations and manufacturing processes to ensure predefined product quality. This involves the understanding of controlling formulation and manufacturing process variables affecting the quality of a drug.”[4]
In an attempt to reach this necessary understanding, the FDA has granted the National Institute of Pharmaceutical Technology and Education a $1.19 million contract. The FDA has said that “The intention of this award is the development of specifications allowing for the implementation of Quality by Design (QbD) framework to improve product quality through science and technology.”[4] The ultimate goal of this research, along with all principles of QbD, is to improve end product quality. The research is scheduled to end in September of 2010, and “the results of the study will potentially serve as the basis for formulating best practices and developing science based guidance documents that can be used by the FDA to evaluate new and generic drug applications.”[4]
Some of the key elements of QbD have already been identified. Chi-wan Chen, Deputy Director of the Office of New Drug Quality Assessment at the CDER, outlined some of the features of QbD that have already been identified in subsequent studies. The elements include:
- Targeting the product profile
- Determining the Critical Quality Attributes (CQAs)
- Linking raw material attributes and process parameters to CQAs and perform risk assessment
- Developing a design space
- Designing and implementing a control strategy
- Managing product life cycle, including continual improvements [3]
So where does the implementation stand today? Big Pharma has been able to pursue this avenue with effectiveness, but many mid-tier Pharma companies have fallen back on old habits. It is believed in the industry that the FDA must continue to apply more pressure on the companies to change, or they will not see a need to expel the resources needed to make significant changes. Success also relies on the industry and the FDA moving toward a cohesive methodology, and sending a message explaining the need for these changes. Designing a QbD solution that is both pragmatic from a compliance standpoint, and flexible from a business perspective, will keep the pressure on industry to truly embrace the principles of QbD. [6]
Sources:
1. FDA Promotes QbD for Biotech Therapies - By Jill Wechsler, October 1, 2008
http://biopharminternational.findpharma.com/biopharm/Quality/FDA-Promotes-QbD-for-Biotech-Therapies/ArticleStandard/Article/detail/557244
2. “Quality by Design (QbD): Myth or Reality” - By Girish Malhotra, PE, President EPCOT International
http://www.pharmpro.com/ShowPR.aspx?PUBCODE=021&ACCT=0000100&ISSUE=0702&RELTYPE=PR&ORIGRELTYPE=ATO&PRODCODE=0000&PRODLETT=N&CommonCount=0
3. FDA Perspective on Quality by Design - By Patricia Van Arnum, Dec. 5 2007
http://pharmtech.findpharma.com/pharmtech/Article/A-FDA-Perspective-on-Quality-by-Design/ArticleStandard/Article/detail/469915
4. Implementation of Quality-by-Design: OGD Initiatives - By Lawrence Yu, PhD, Director for Science Office of Generic Drugs, FDA
http://www.fda.gov/ohrms/dockets/AC/06/slides/2006-4241s1_8.ppt
3. FDA Awards NIPTE $1.19 Million Contract to Develop Quality by Design (QbD) Guidance Elements - October 29, 2008
http://www.businesswire.com/portal/site/google/?ndmViewId=news_view&newsId=20081029005227&newsLang=en
6. QbD: An Interim Report Card - By Bikash Chatterjee, Pharmtech Associates, Inc.
http://www.pharmamanufacturing.com/articles/2007/158.html
Wednesday, July 15, 2009
Congress Considers Taxing Prescription Drug Advertising
By: Amy Lotman, CIS Senior Compliance Manager
amylotman@cis-partners.com
The advertising, broadcast and medical publishing sectors were thrown into a tizzy on June 16, when reports from Capitol Hill said that removing the tax deductibility of drug promotional expenses remains a live issue in the funding discussions around health care reform.
There have been reverberations for over a year that pharma’s critics on Capitol Hill might try to raise some money for health care reform by tapping into the drug industry’s marketing budgets. White House Chief of Staff Rahm Emanuel has previously talked about giving manufacturers a choice between deducting R&D expenses or promotional expenses.
Rep. Charles Rangel (D-NY), the very powerful Chairman of the House Ways & Means Committee, recently made some public comments about abolishing the deduction. Chairman Rangel told reporters that House tax writers are considering a $37 billion proposal that would prohibit companies from taking deductions on advertising for prescription drugs, saying that the tendency to "mumble" about side effects is "wrong."
The $37 billion price tag that Rangel casually attached to the possible change quantified the challenge and gave it a magnitude that made it more threatening.
While Rep. Rangel admitted that the pharmaceutical advertising provision would only pay for a tiny piece of a bill that is expected to cost $1.2 trillion over 10 years, he emphasized that a number of new tax provisions may be needed to ensure the bill’s effectiveness.
Advertising, media and marketing groups are intensifying grassroots efforts to defeat such a proposal.
Sources:
http://rangel.house.gov/
http://www.bloomberg.com/apps/news?pid=20601103&sid=aeEJZicjYE60
amylotman@cis-partners.com
The advertising, broadcast and medical publishing sectors were thrown into a tizzy on June 16, when reports from Capitol Hill said that removing the tax deductibility of drug promotional expenses remains a live issue in the funding discussions around health care reform.
There have been reverberations for over a year that pharma’s critics on Capitol Hill might try to raise some money for health care reform by tapping into the drug industry’s marketing budgets. White House Chief of Staff Rahm Emanuel has previously talked about giving manufacturers a choice between deducting R&D expenses or promotional expenses.
Rep. Charles Rangel (D-NY), the very powerful Chairman of the House Ways & Means Committee, recently made some public comments about abolishing the deduction. Chairman Rangel told reporters that House tax writers are considering a $37 billion proposal that would prohibit companies from taking deductions on advertising for prescription drugs, saying that the tendency to "mumble" about side effects is "wrong."
The $37 billion price tag that Rangel casually attached to the possible change quantified the challenge and gave it a magnitude that made it more threatening.
While Rep. Rangel admitted that the pharmaceutical advertising provision would only pay for a tiny piece of a bill that is expected to cost $1.2 trillion over 10 years, he emphasized that a number of new tax provisions may be needed to ensure the bill’s effectiveness.
Advertising, media and marketing groups are intensifying grassroots efforts to defeat such a proposal.
Sources:
http://rangel.house.gov/
http://www.bloomberg.com/apps/news?pid=20601103&sid=aeEJZicjYE60
Tuesday, July 14, 2009
Faster, Better, Stronger: Speeding up Medical Imagery
By: Craig Kubicek, CIS Compliance Associate
craigkubicek@cis-partners.com
It is absolutely amazing to think about what computers can do nowadays. They allow us to stay in contact with others, check our bank accounts, read the news, follow our favorite teams, etcetera, etcetera.
Our lives have become so easy as we sit down in front of our computers to perform our jobs. However, I am not here to make you read about how personal computing has shaped our lives. I would like to touch on a topic that not many of us stop to think about, or for that matter, care about: Computing for Researchers.
Computers have become such a staple of our lives that even researchers rely on them. However, researchers are power hungry and require many computers linked up to provide them enough processing power to perform their biological researched functions and mathematical calculations. Fortunately, a corporation named Nvidia has created a huge breakthrough in the realm of supercomputers.
Nvidia’s specialty is Graphical Processing Units (GPU’s). Just recently, Nvidia produced the Tesla, which brings supercomputing to the level of personal computing. A supercomputer can now sit on a desk, instead of taking up a whole room. The concept is quite simple. The Tesla GPU is used inside a computer to reduce the amount of calculations and graphics processing that the Central Processing Unit (CPU) must perform. By taking away this heavy load of instructions, the CPU is given some room to breathe. Actually, lots of room to breathe.
What does this mean for the world? It means that the possibilities are becoming endless. Researchers can “simulate the delivery of novel nanoparticle chemotherapy drug to cancerous tissue. Simulation allows scientists to predict experimental outcomes and thus reduce the cost of development and time to clinical relevance.” [i] Boston Scientific, a worldwide producer of medical devices, also needs to simulate its products for results. With the use of Nvidia’s Tesla GPU it was able to process its simulations 25 times faster.[ii] It is not all about simulating things faster, “these advances also foster the development of new algorithms for simulating biomedical processes inside the body.” The ability to have a computer perform operations faster means that analyzing protein syntheses and chemical structures can occur quicker.
The more companies like Nvidia that can cut down on computational time, the better. "Time on a supercomputer can be extremely difficult to get, especially since some of our computations run for weeks to months. Also, buying a supercomputer is expensive for every university research group," said Axel Kohlmeyer, associate director at the Center for Molecular Modeling at the University of Pennsylvania. Kohlmeyer and the research team were able run their “molecular dynamics algorithms up to 100X faster and more importantly run bigger and more complex simulations and do research that was impossible to do before.”[iii] Of course, only with the help of Nvidia’s Tesla GPU.
No, I am not, nor have I ever been a Nvidia salesman, but I must confess that new innovations in technology have always thrilled me. It is exciting to think that clinical trials, medical procedures, cancer research simulations and much more can be sped up with only a desktop computer. Here’s to the future.
[i] http://www.accelereyes.com/success_story/drug_delivery_model.php
[ii] http://www.nvidia.com/object/acceleware_boston_scientific.html
[iii] http://www.reuters.com/article/pressRelease/idUS106675+04-May-2009+PRN20090504
craigkubicek@cis-partners.com
It is absolutely amazing to think about what computers can do nowadays. They allow us to stay in contact with others, check our bank accounts, read the news, follow our favorite teams, etcetera, etcetera.
Our lives have become so easy as we sit down in front of our computers to perform our jobs. However, I am not here to make you read about how personal computing has shaped our lives. I would like to touch on a topic that not many of us stop to think about, or for that matter, care about: Computing for Researchers.
Computers have become such a staple of our lives that even researchers rely on them. However, researchers are power hungry and require many computers linked up to provide them enough processing power to perform their biological researched functions and mathematical calculations. Fortunately, a corporation named Nvidia has created a huge breakthrough in the realm of supercomputers.
Nvidia’s specialty is Graphical Processing Units (GPU’s). Just recently, Nvidia produced the Tesla, which brings supercomputing to the level of personal computing. A supercomputer can now sit on a desk, instead of taking up a whole room. The concept is quite simple. The Tesla GPU is used inside a computer to reduce the amount of calculations and graphics processing that the Central Processing Unit (CPU) must perform. By taking away this heavy load of instructions, the CPU is given some room to breathe. Actually, lots of room to breathe.
What does this mean for the world? It means that the possibilities are becoming endless. Researchers can “simulate the delivery of novel nanoparticle chemotherapy drug to cancerous tissue. Simulation allows scientists to predict experimental outcomes and thus reduce the cost of development and time to clinical relevance.” [i] Boston Scientific, a worldwide producer of medical devices, also needs to simulate its products for results. With the use of Nvidia’s Tesla GPU it was able to process its simulations 25 times faster.[ii] It is not all about simulating things faster, “these advances also foster the development of new algorithms for simulating biomedical processes inside the body.” The ability to have a computer perform operations faster means that analyzing protein syntheses and chemical structures can occur quicker.
The more companies like Nvidia that can cut down on computational time, the better. "Time on a supercomputer can be extremely difficult to get, especially since some of our computations run for weeks to months. Also, buying a supercomputer is expensive for every university research group," said Axel Kohlmeyer, associate director at the Center for Molecular Modeling at the University of Pennsylvania. Kohlmeyer and the research team were able run their “molecular dynamics algorithms up to 100X faster and more importantly run bigger and more complex simulations and do research that was impossible to do before.”[iii] Of course, only with the help of Nvidia’s Tesla GPU.
No, I am not, nor have I ever been a Nvidia salesman, but I must confess that new innovations in technology have always thrilled me. It is exciting to think that clinical trials, medical procedures, cancer research simulations and much more can be sped up with only a desktop computer. Here’s to the future.
[i] http://www.accelereyes.com/success_story/drug_delivery_model.php
[ii] http://www.nvidia.com/object/acceleware_boston_scientific.html
[iii] http://www.reuters.com/article/pressRelease/idUS106675+04-May-2009+PRN20090504
Monday, July 13, 2009
CIS Recognizes Steven Moore
Dear Blog Readers,
On Friday, CIS founders Jim Collins and Toni Barsh awarded the 2009 President's Award to Business Development Director Steven Moore. Those of you who have been following along for a while have undoubtedly read Steve's tales of the road, have enjoyed stories from numerous conferences, and have learned about some of his favorite (and least favorite) things. But what you have not read about is Steve's tireless dedication to CIS, his clients, and his colleagues.
Steve (almost) always has a smile on his face, and time to lend a hand to a fellow employee. In his time with CIS he has grown both personally and professionally and, in the opinion of those around him, he continues to do so. Having worked with him for the past year, I can attest that he is an excellent mentor, as well as a great example of the power of hard work and enthusiasm.
Congratulations Steve, and thank you for all that you do "For Our Space."
*
On Friday, CIS founders Jim Collins and Toni Barsh awarded the 2009 President's Award to Business Development Director Steven Moore. Those of you who have been following along for a while have undoubtedly read Steve's tales of the road, have enjoyed stories from numerous conferences, and have learned about some of his favorite (and least favorite) things. But what you have not read about is Steve's tireless dedication to CIS, his clients, and his colleagues.
Steve (almost) always has a smile on his face, and time to lend a hand to a fellow employee. In his time with CIS he has grown both personally and professionally and, in the opinion of those around him, he continues to do so. Having worked with him for the past year, I can attest that he is an excellent mentor, as well as a great example of the power of hard work and enthusiasm.
Congratulations Steve, and thank you for all that you do "For Our Space."
*
Thursday, July 9, 2009
The PCB Celebrates 500 Posts!
Dear PCB Readers,
This week we are proud to announce a milestone, our blog has reached 500 posts! There are many people to thank for the success of the Pharma Compliance Blog: Steven Moore, the mastermind behind the blog, and a frequent and popular contributer; CIS employees past and present, who have dedicated countless hours of their time to report the latest breaking industry news, and provide their insight into the tangled world of pharmaceutical compliance; and last but certainly not least, you the readers. Without you, none of this would be possible.
So for everyone out there who has contributed to the blog, been a loyal reader of the blog, and posted comments on the blog, thank you. We hope to keep you reading for many years to come.
For Your Space,
Dana Zelig, PCB Editor
*
This week we are proud to announce a milestone, our blog has reached 500 posts! There are many people to thank for the success of the Pharma Compliance Blog: Steven Moore, the mastermind behind the blog, and a frequent and popular contributer; CIS employees past and present, who have dedicated countless hours of their time to report the latest breaking industry news, and provide their insight into the tangled world of pharmaceutical compliance; and last but certainly not least, you the readers. Without you, none of this would be possible.
So for everyone out there who has contributed to the blog, been a loyal reader of the blog, and posted comments on the blog, thank you. We hope to keep you reading for many years to come.
For Your Space,
Dana Zelig, PCB Editor
*
Wednesday, July 8, 2009
E-Verify: What You Need to Know Before September 8, 2009
By Karen Agama, CIS Compliance Consultant
karenagama@cis-partners.com
Certain federal contracts awarded a solicitation issued after September 8, 2009 will include a clause requiring the use of E-Verify, which relates to immigration and work authorization. So, does that mean that current or prospective federal contractors are required by the final rule to enroll in E-Verify now?
According to the U.S. Citizenship and Immigration Services (USCIS),[1] “the final rule applies to solicitations issued and contracts awarded after the applicability date of the final rule in accordance with FAR 1.108(d). The final rule will become applicable to contractors on September 8, 2009. Under the final rule, employers are required to enroll in E-Verify if and when they are awarded a federal contract or subcontract that requires participation in E-Verify as a term of the contract. Verification of employees through E-Verify is limited to new hires only, unless you are a federal contractor who has been awarded a contract on or after September 8, 2009.”
USCIS goes on to clarify that federal contractor participants in E-Verify are required to use E-Verify for:
As the individual “in the know” about your federal contracts, you will want to alert your HR department to this requirement, as those responsible for new hire processing would be required to complete an online tutorial to meet the new requirement.
Immigration and employment eligibility concerns have received increasing public and political emphasis in recent years, and the government has been computerizing and intercommunicating with greater efficiency, so this requirement seems a natural outgrowth of these converging factors.
It makes sense, really. The federal government, which regulates its own contracts and employment eligibility, would not appear fully competent if found contracting with vendors that employ staff not authorized to work in the U.S.
Feel free to contact us if you have questions about this or other compliance matters, at:
http://www.cis-partners.com/contactus.php
Sources:
[1] U.S. Citizenship and Immigration Services, “Frequently Asked Questions: Federal Contractors and E-Verify.” June 3, 2009. U.S. Department of Homeland Security. http://www.uscis.gov/portal/site/uscis/menuitem.5af9bb95919f35e66f614176543f6d1a/?vgnextoid=cb2a535e0869d110VgnVCM1000004718190aRCRD&vgnextchannel=534bbd181e09d110VgnVCM1000004718190aRCRD (accessed June 20, 2009).
karenagama@cis-partners.com
Certain federal contracts awarded a solicitation issued after September 8, 2009 will include a clause requiring the use of E-Verify, which relates to immigration and work authorization. So, does that mean that current or prospective federal contractors are required by the final rule to enroll in E-Verify now?
According to the U.S. Citizenship and Immigration Services (USCIS),[1] “the final rule applies to solicitations issued and contracts awarded after the applicability date of the final rule in accordance with FAR 1.108(d). The final rule will become applicable to contractors on September 8, 2009. Under the final rule, employers are required to enroll in E-Verify if and when they are awarded a federal contract or subcontract that requires participation in E-Verify as a term of the contract. Verification of employees through E-Verify is limited to new hires only, unless you are a federal contractor who has been awarded a contract on or after September 8, 2009.”
USCIS goes on to clarify that federal contractor participants in E-Verify are required to use E-Verify for:
- All new employees, following completion of the Employment Eligibility Verification Form I-9 (Form I-9); and
- All existing employees who are classified as “employees assigned to the contract.”
As the individual “in the know” about your federal contracts, you will want to alert your HR department to this requirement, as those responsible for new hire processing would be required to complete an online tutorial to meet the new requirement.
Immigration and employment eligibility concerns have received increasing public and political emphasis in recent years, and the government has been computerizing and intercommunicating with greater efficiency, so this requirement seems a natural outgrowth of these converging factors.
It makes sense, really. The federal government, which regulates its own contracts and employment eligibility, would not appear fully competent if found contracting with vendors that employ staff not authorized to work in the U.S.
Feel free to contact us if you have questions about this or other compliance matters, at:
http://www.cis-partners.com/contactus.php
Sources:
[1] U.S. Citizenship and Immigration Services, “Frequently Asked Questions: Federal Contractors and E-Verify.” June 3, 2009. U.S. Department of Homeland Security. http://www.uscis.gov/portal/site/uscis/menuitem.5af9bb95919f35e66f614176543f6d1a/?vgnextoid=cb2a535e0869d110VgnVCM1000004718190aRCRD&vgnextchannel=534bbd181e09d110VgnVCM1000004718190aRCRD (accessed June 20, 2009).
Tuesday, July 7, 2009
The American Recovery and Reinvestment Act Marks It's 100 Day Anniversary
By: Kerri McCutchin, CIS Compliance Associate
kerrimccutchin@cis-partners.com
The American Recovery and Reinvestment Act (ARRA) of 2009 provides a stimulus response to the current downturn within the economy. Enacted on February 17, 2009 by President Barack Obama, the ARRA provides a means of transparency and accountability that keeps Americans informed of how, when, and where their tax dollars are being spent. Led by a new Recovery Board, this act contains internal measures to ensure efficiency and necessary spending [1]. The ARRA totals $787 billion and highlights key areas of the economy such as education and training, tax relief, infrastructure and science, state and local fiscal relief, protecting the vulnerable, energy, and healthcare [1]. Healthcare receives approximately $150 billion in funds, which includes $87 billion for Medicaid, $24.7 billion to subsidize private health insurance for those who have lost their jobs, $19.2 billion for health information technology, $10 billion for the National Institutes of Health (NIH), and $2 billion for community health centers.
Thursday, May 28, 2009 marked the 100 day anniversary of the enactment of The American Recovery and Reinvestment Act. To recognize this anniversary, Secretary of U.S. Health and Human Services (HHS) Kathleen Sebelius, highlighted the progress made in the first 100 days, and discussed the ARRA's emphasis on community health centers. The ARRA assigns $2 billion in grant funding to health centers over a two year period. In this grant, $500 million will support new health center sites and service areas, increase services at existing sites, and concentrate on rises in uninsured populations. The remaining $1.5 billion will be utilized to support construction, and renovation and equipment. Health information technology systems in health centers and health center controlled networks will also be included within this allocation. In her address, Secretary Sebelius also announced the release of $81.7 million to expand services offered at the nation’s health centers, which last year provided more than 17 million families with comprehensive, high quality and family orientated primary health care [3].
Secretary Sebelius further highlights the importance of health centers, notably for the uninsured:
Despite the increasing number of uninsured individuals in the United States, the ARRA's allocation of funds to community health centers can hopefully provide relief, as well as quality care, to those who do not have health insurance.
Sources:
[1] http://www.recovery.gov/
[2] http://content.nejm.org/cgi/content/full/360/11/1057#T1
[3] http://www.hhs.gov/news/press/2009pres/05/20090528a.html
kerrimccutchin@cis-partners.com
The American Recovery and Reinvestment Act (ARRA) of 2009 provides a stimulus response to the current downturn within the economy. Enacted on February 17, 2009 by President Barack Obama, the ARRA provides a means of transparency and accountability that keeps Americans informed of how, when, and where their tax dollars are being spent. Led by a new Recovery Board, this act contains internal measures to ensure efficiency and necessary spending [1]. The ARRA totals $787 billion and highlights key areas of the economy such as education and training, tax relief, infrastructure and science, state and local fiscal relief, protecting the vulnerable, energy, and healthcare [1]. Healthcare receives approximately $150 billion in funds, which includes $87 billion for Medicaid, $24.7 billion to subsidize private health insurance for those who have lost their jobs, $19.2 billion for health information technology, $10 billion for the National Institutes of Health (NIH), and $2 billion for community health centers.
Thursday, May 28, 2009 marked the 100 day anniversary of the enactment of The American Recovery and Reinvestment Act. To recognize this anniversary, Secretary of U.S. Health and Human Services (HHS) Kathleen Sebelius, highlighted the progress made in the first 100 days, and discussed the ARRA's emphasis on community health centers. The ARRA assigns $2 billion in grant funding to health centers over a two year period. In this grant, $500 million will support new health center sites and service areas, increase services at existing sites, and concentrate on rises in uninsured populations. The remaining $1.5 billion will be utilized to support construction, and renovation and equipment. Health information technology systems in health centers and health center controlled networks will also be included within this allocation. In her address, Secretary Sebelius also announced the release of $81.7 million to expand services offered at the nation’s health centers, which last year provided more than 17 million families with comprehensive, high quality and family orientated primary health care [3].
Secretary Sebelius further highlights the importance of health centers, notably for the uninsured:
“The economic downturn is hurting all of us and when workers lose their jobs,Currently, the HHS has awarded 126 community health centers approximately $150 million in Recovery Act grant funds. More than 750,000 individuals will be provided with access to healthcare with this allocation of grants. In addition, HHS has allotted $338 million in Increased Demand for Services grants for health centers. These funds will provide care to more than 2 million additional patients in health centers over the next two years, including approximately 1 million uninsured individuals. Furthermore, within two years, health centers will utilize these funds to generate and maintain roughly 6,500 health center jobs [3].
they often lose their health insurance, too. Community health centers provide
essential care for families across the country that do not have insurance
or cannot afford the high cost of care. The Recovery Act grants and the
funding we have released are key investments that will help deliver care to
millions of Americans” [3].
Despite the increasing number of uninsured individuals in the United States, the ARRA's allocation of funds to community health centers can hopefully provide relief, as well as quality care, to those who do not have health insurance.
Sources:
[1] http://www.recovery.gov/
[2] http://content.nejm.org/cgi/content/full/360/11/1057#T1
[3] http://www.hhs.gov/news/press/2009pres/05/20090528a.html
Monday, July 6, 2009
Why Did it Take so Long?
By: Suzanne Tavares, CIS Compliance Director
suzannetavares@cis-partners.com
On June 22, 2009 President Barack Obama signed into law The Family Smoking Prevention and Tobacco Control Act. This law will provide the FDA (Food and Drug Administration) broad authority over the way tobacco products are made and sold, and is intended to dilute the appeal tobacco manufacturers have on younger generations.
Under the new law, tobacco manufacturers must register with the FDA and provide details on the products, such as active ingredients and additives. In addition, the FDA will assess fees on manufacturers to pay for the cost of FDA tobacco regulation. So what led up to this law being passed? To shed some light on the matter, here are some highlights of over 50 years of facts on why cigarette smoking is hazardous to consumers, and expensive for the US government:
It is a shame that a bill like this did not pass earlier, but now that it is law the lives and dollars it saves will benefit us all.
Sources:
http://online.wsj.com/article/SB124566796165436743.html
http://www.nytimes.com/2009/06/12/business/12tobacco.html
http://www.cdc.gov/tobacco/data_statistics/fact_sheets/fast_facts/index.htm
http://www.cdc.gov/nchs/about/major/nhis/tobacco/nhis_tob_1.2.htm
suzannetavares@cis-partners.com
On June 22, 2009 President Barack Obama signed into law The Family Smoking Prevention and Tobacco Control Act. This law will provide the FDA (Food and Drug Administration) broad authority over the way tobacco products are made and sold, and is intended to dilute the appeal tobacco manufacturers have on younger generations.
Under the new law, tobacco manufacturers must register with the FDA and provide details on the products, such as active ingredients and additives. In addition, the FDA will assess fees on manufacturers to pay for the cost of FDA tobacco regulation. So what led up to this law being passed? To shed some light on the matter, here are some highlights of over 50 years of facts on why cigarette smoking is hazardous to consumers, and expensive for the US government:
- In 1957, Surgeon General Dr. Burney stated: “many independent studies have thus confirmed beyond reasonable doubt that there is a high degree of statistical association between lung cancer and heavy and prolonged cigarette smoking,” and that “excessive smoking is one of the causative factors in the increasing incidence of lung cancer.”
- From 1964 to 2006, over 25 Surgeon General reports were issued informing the public of the link between cigarette smoking and secondary smoke to multiple cancers, COPD (Chronic Obstructive Pulmonary Disease) and cardiovascular disease.
- Annually in the US, one in five deaths (443,000 a year) are attributed to direct cigarette smoking and 49,000 are caused by secondary smoke.
- For every one person that dies from smoking related disease, 20 more suffer from a smoking related disease.
- In addition to the loss of lives, the annual financial burden of cigarette smoking on the US adds up to over $200 billion.
It is a shame that a bill like this did not pass earlier, but now that it is law the lives and dollars it saves will benefit us all.
Sources:
http://online.wsj.com/article/SB124566796165436743.html
http://www.nytimes.com/2009/06/12/business/12tobacco.html
http://www.cdc.gov/tobacco/data_statistics/fact_sheets/fast_facts/index.htm
http://www.cdc.gov/nchs/about/major/nhis/tobacco/nhis_tob_1.2.htm
Thursday, July 2, 2009
Puff, Puff, Passed! - President Obama passes the Family Smoking Prevention and Tobacco Control Act
By: Jordan Mummau, CIS Compliance Associate
jordanmummau@cis-partners.com
Imagine yourself back in high school; this may take some longer than others. You pull up to the Friday night party that you were never really invited to, blasting “Fight for your Right to Party” in your parents car, which you begged to use after you accidentally backed into the garage door. You step out of the car and scan the scene, waiting for the right time to make your appearance. After giving a few winks and a head nod, you reach into your Lee Dungaree jean pockets and pull out a comb to carefully sculpt your hair, which is almost as greasy as your face. Next, you reach into the pocket of your vintage polo t-shirt, which you won at a church retreat 3 years ago, and pull out a pack of cigarettes. You are not an experienced smoker, however, while leaning on the hood of your father's 1960 Oldsmobile Cutlass, the messages endorsed by ritzy celebs and a cartoon camel run through your mind as they entice you to puff away. The night ends. You now have fewer friends than when you came, there is a dent in the hood of your father’s car, and you have acquired a horribly sore throat that even Chuck Norris couldn’t fight (Okay, so everyone might not have had the same teenage experience).
Back to 2009. The messages and advertisements the tobacco industry have used for decades to lure society's impressionable young adults, will now come slapped with a giant WARNING label[i].
Kathleen Sebelius, Secretary of Health and Human Services states that, “the Food and Drug Administration’s (FDA) regulation of tobacco products will be a critical piece of a coordinated effort to save lives, lower costs and reduce suffering from heart disease, cancer and other tobacco-related illness.”[ii] This statement comes after President Obama’s decision to sign the Family Smoking Prevention and Tobacco Control Act, which hopes to alleviate some of the pressure tobacco companies allegedly place on America’s youth by regulating the methods in which the companies produce, market, and sell their products. The Congressional Budget Office has estimated that the new law could reduce youth smoking by 11 percent and adult smoking by 2 percent over the next decade[iii].
Under this new legislation[iv]:
- Cigarette packages will have warning labels that cover 50 percent of the front and rear. The word "WARNING" must be included in capital letters.
- Any remaining tobacco-related sponsorships of sports and entertainment events will be banned, as well as giveaways of non-tobacco items with the purchase of a tobacco product. A federal ban will be imposed on all outdoor tobacco advertising within 1,000 feet of schools and playgrounds.
- Point-of-sale advertising will be limited to adults-only facilities, and remaining vending machines will disappear except in places restricted to adults. Retailers who sell to minors will be subject to federal enforcement and penalties.
- Smokers, particularly young adults, will find they can no longer buy cigarettes sweetened by candy flavors or any herbs or spices such as strawberry, grape, orange, clove, cinnamon or vanilla. Cigarettes advertised as "light" or "mild," giving the impression that they are not as harmful to health, will no longer be found on store shelves.
The bill passed by Obama, who ironically is a smoker, represents a bill of historic measures that will hopefully reduce the number of people suffering from heart and lung diseases, cancer, and other illnesses that are related with tobacco use. Sebelius remarked, “These illnesses kill hundreds of thousands of Americans every year, and the new law gives us the tools to effectively address this major public health issue”ii. There are an estimated 45 million smokers within the United States. Of that 45 million, a projected 443,600 people die each year from a tobacco related illness[v].
Hopefully you wash your once greasy hair more than once a month, and have acquired more friends over the years than just your shadow. However, if you still smoke, be prepared for drastic changes per the FDA including changes in labeling, marketing, and the content of the actual product itself. Remember, the FDA is synonymous with ‘safe to use’ products. If the FDA is going to approve anything that contains already known harmful material, it is most likely going to be regulated to cause as little harm as possible, which could mean major changes for the entire tobacco industry. For those of us in the pharmaceutical realm, it will be interesting to monitor the regulations placed on tobacco products, to determine if these regulations set by the FDA will result in fewer people seeking healthcare treatment for tobacco related illnesses in the years to come.
As a side note, if your father still has that 1960 Cutlass, minus the dented hood, give me a call.
Sources:
[i] Windish, Joe. "The Family Smoking Prevention and Tobacco Control Act." The Moderate Voice. 13 June 2009. 22 June 2009 http://themoderatevoice.com/35259/the-family-smoking-prevention-and-tobacco-control-act/
[ii] "News Release." US Department of Health and Human Services. 11 June 2009. 22 June 2009 http://www.hhs.gov/news/press/2009pres/06/20090611d.html
[iii] "Obama to Sign Sweeping Anti-Smoking Bill." MSNBC. 22 June 2009. Associated Press. 22 June 2009 http://www.msnbc.msn.com/id/31481823/ns/politics-white_house/
[iv] "Obama to Sign Tobacco Regulation Bill." Kyw News Radio. 22 June 2009. 22 June 2009 http://www.kyw1060.com/Obama-to-Sign-Tobacco-Regulation-Bill/4647399
[v] "Cigarette Smoking." Cancer. 21 May 2009. American Cancer Society. 24 June 2009 http://www.cancer.org/docroot/PED/content/PED_10_2X_Cigarette_Smoking.asp
jordanmummau@cis-partners.com
Imagine yourself back in high school; this may take some longer than others. You pull up to the Friday night party that you were never really invited to, blasting “Fight for your Right to Party” in your parents car, which you begged to use after you accidentally backed into the garage door. You step out of the car and scan the scene, waiting for the right time to make your appearance. After giving a few winks and a head nod, you reach into your Lee Dungaree jean pockets and pull out a comb to carefully sculpt your hair, which is almost as greasy as your face. Next, you reach into the pocket of your vintage polo t-shirt, which you won at a church retreat 3 years ago, and pull out a pack of cigarettes. You are not an experienced smoker, however, while leaning on the hood of your father's 1960 Oldsmobile Cutlass, the messages endorsed by ritzy celebs and a cartoon camel run through your mind as they entice you to puff away. The night ends. You now have fewer friends than when you came, there is a dent in the hood of your father’s car, and you have acquired a horribly sore throat that even Chuck Norris couldn’t fight (Okay, so everyone might not have had the same teenage experience).
Back to 2009. The messages and advertisements the tobacco industry have used for decades to lure society's impressionable young adults, will now come slapped with a giant WARNING label[i].
Kathleen Sebelius, Secretary of Health and Human Services states that, “the Food and Drug Administration’s (FDA) regulation of tobacco products will be a critical piece of a coordinated effort to save lives, lower costs and reduce suffering from heart disease, cancer and other tobacco-related illness.”[ii] This statement comes after President Obama’s decision to sign the Family Smoking Prevention and Tobacco Control Act, which hopes to alleviate some of the pressure tobacco companies allegedly place on America’s youth by regulating the methods in which the companies produce, market, and sell their products. The Congressional Budget Office has estimated that the new law could reduce youth smoking by 11 percent and adult smoking by 2 percent over the next decade[iii].
Under this new legislation[iv]:
- Cigarette packages will have warning labels that cover 50 percent of the front and rear. The word "WARNING" must be included in capital letters.
- Any remaining tobacco-related sponsorships of sports and entertainment events will be banned, as well as giveaways of non-tobacco items with the purchase of a tobacco product. A federal ban will be imposed on all outdoor tobacco advertising within 1,000 feet of schools and playgrounds.
- Point-of-sale advertising will be limited to adults-only facilities, and remaining vending machines will disappear except in places restricted to adults. Retailers who sell to minors will be subject to federal enforcement and penalties.
- Smokers, particularly young adults, will find they can no longer buy cigarettes sweetened by candy flavors or any herbs or spices such as strawberry, grape, orange, clove, cinnamon or vanilla. Cigarettes advertised as "light" or "mild," giving the impression that they are not as harmful to health, will no longer be found on store shelves.
The bill passed by Obama, who ironically is a smoker, represents a bill of historic measures that will hopefully reduce the number of people suffering from heart and lung diseases, cancer, and other illnesses that are related with tobacco use. Sebelius remarked, “These illnesses kill hundreds of thousands of Americans every year, and the new law gives us the tools to effectively address this major public health issue”ii. There are an estimated 45 million smokers within the United States. Of that 45 million, a projected 443,600 people die each year from a tobacco related illness[v].
Hopefully you wash your once greasy hair more than once a month, and have acquired more friends over the years than just your shadow. However, if you still smoke, be prepared for drastic changes per the FDA including changes in labeling, marketing, and the content of the actual product itself. Remember, the FDA is synonymous with ‘safe to use’ products. If the FDA is going to approve anything that contains already known harmful material, it is most likely going to be regulated to cause as little harm as possible, which could mean major changes for the entire tobacco industry. For those of us in the pharmaceutical realm, it will be interesting to monitor the regulations placed on tobacco products, to determine if these regulations set by the FDA will result in fewer people seeking healthcare treatment for tobacco related illnesses in the years to come.
As a side note, if your father still has that 1960 Cutlass, minus the dented hood, give me a call.
Sources:
[i] Windish, Joe. "The Family Smoking Prevention and Tobacco Control Act." The Moderate Voice. 13 June 2009. 22 June 2009 http://themoderatevoice.com/35259/the-family-smoking-prevention-and-tobacco-control-act/
[ii] "News Release." US Department of Health and Human Services. 11 June 2009. 22 June 2009 http://www.hhs.gov/news/press/2009pres/06/20090611d.html
[iii] "Obama to Sign Sweeping Anti-Smoking Bill." MSNBC. 22 June 2009. Associated Press. 22 June 2009 http://www.msnbc.msn.com/id/31481823/ns/politics-white_house/
[iv] "Obama to Sign Tobacco Regulation Bill." Kyw News Radio. 22 June 2009. 22 June 2009 http://www.kyw1060.com/Obama-to-Sign-Tobacco-Regulation-Bill/4647399
[v] "Cigarette Smoking." Cancer. 21 May 2009. American Cancer Society. 24 June 2009 http://www.cancer.org/docroot/PED/content/PED_10_2X_Cigarette_Smoking.asp
Wednesday, July 1, 2009
ACCME Considers Placing a Label on CME
By: Jackie O’Connor, CIS Marketing Associate
jacquelineoconnor@cis-partners.com
Following up on a previous CIS CME blog article, The ACCME (Accreditation Council for Continuing Medical Education) recently held ‘Calls for Comment’ on their website regarding new procedures that would differentiate between CME activities that are commercially funded and those that are not. “ACCME proposes to consider a new designation and review process for providers that wish to identify their program of CME as one that does not utilize funds from commercial interests that have been donated to support continuing medical education, e.g., Commercial Support-Free.”[1] The ‘ACCME-defined designation of Commercial Support –Free Accredited Continuing Medical Education’ has received responses from The Pharmaceutical Research and Manufacturers of America (PhRMA) and The Alliance for Continuing Medical Education (The Alliance).
The Alliance does not support the proposed plan. They believe “that all continuing medical education for health care professionals should be unbiased and based on the rigor of scientific and clinical discovery regardless of funding source.”[2] Their concern is what this proposal is implying about the current CME system – that commercially funded CME courses are biased and inferior to those that are support-free. Offering their input, “The Alliance recommends that organizations receiving funds from advertising or promotion establish firewall between the promotional and education departments and not “bundle” education activities with promotional fees.”2 The ACCME needs to maintain a barrier between the organizations that fund the activities and the CME content.
PhRMA response shares similar concerns as the Alliance. PhRMA recognizes the influence that pharmaceutical manufacturers have in supporting quality CME programs. Creating two types of CME programs would indicate that the quality of the courses varies simply based on whether it was funded or not. They point out that their main concern is to focus on who could potentially be affected, for example, “ any distinction that creates such an inference potentially harms physicians and patients because educational programs may not be funded, notwithstanding documented needed, because Providers may believe that such a designation is important for their program.”[1]
The key issue is both PhRMA and The Alliance feel this new system is without merit, since there is no proven evidence that the CME providers affect the quality of the content and knowledge offered at sponsored events.
This isn’t a cut and dry situation, and putting label, especially one associated with a negative connotation, on CME programs could lead to a rift in communication and confidence in CME activities. The bottom line is that there shouldn’t be a difference in the content between sponsored and non-sponsored CME courses. The quality of knowledge and intentions should remain the same so that these courses are truly beneficial to those attending them, and to the end result, their patients.
Sources:
[1] http://policymed.typepad.com/files/phrma-letter-to-accme-5-27-09.pdf
[2] http://www.acme-assn.org/advocacy_pg/Alliance'sResponseToACCMEApril09CallForComments.doc
ACCME website:
http://www.accme.org/index.cfm/fa/alerts.detail/alert_id/d43685f0-0218-4c77-906c-f18ae16f24bf
jacquelineoconnor@cis-partners.com
Following up on a previous CIS CME blog article, The ACCME (Accreditation Council for Continuing Medical Education) recently held ‘Calls for Comment’ on their website regarding new procedures that would differentiate between CME activities that are commercially funded and those that are not. “ACCME proposes to consider a new designation and review process for providers that wish to identify their program of CME as one that does not utilize funds from commercial interests that have been donated to support continuing medical education, e.g., Commercial Support-Free.”[1] The ‘ACCME-defined designation of Commercial Support –Free Accredited Continuing Medical Education’ has received responses from The Pharmaceutical Research and Manufacturers of America (PhRMA) and The Alliance for Continuing Medical Education (The Alliance).
The Alliance does not support the proposed plan. They believe “that all continuing medical education for health care professionals should be unbiased and based on the rigor of scientific and clinical discovery regardless of funding source.”[2] Their concern is what this proposal is implying about the current CME system – that commercially funded CME courses are biased and inferior to those that are support-free. Offering their input, “The Alliance recommends that organizations receiving funds from advertising or promotion establish firewall between the promotional and education departments and not “bundle” education activities with promotional fees.”2 The ACCME needs to maintain a barrier between the organizations that fund the activities and the CME content.
PhRMA response shares similar concerns as the Alliance. PhRMA recognizes the influence that pharmaceutical manufacturers have in supporting quality CME programs. Creating two types of CME programs would indicate that the quality of the courses varies simply based on whether it was funded or not. They point out that their main concern is to focus on who could potentially be affected, for example, “ any distinction that creates such an inference potentially harms physicians and patients because educational programs may not be funded, notwithstanding documented needed, because Providers may believe that such a designation is important for their program.”[1]
The key issue is both PhRMA and The Alliance feel this new system is without merit, since there is no proven evidence that the CME providers affect the quality of the content and knowledge offered at sponsored events.
This isn’t a cut and dry situation, and putting label, especially one associated with a negative connotation, on CME programs could lead to a rift in communication and confidence in CME activities. The bottom line is that there shouldn’t be a difference in the content between sponsored and non-sponsored CME courses. The quality of knowledge and intentions should remain the same so that these courses are truly beneficial to those attending them, and to the end result, their patients.
Sources:
[1] http://policymed.typepad.com/files/phrma-letter-to-accme-5-27-09.pdf
[2] http://www.acme-assn.org/advocacy_pg/Alliance'sResponseToACCMEApril09CallForComments.doc
ACCME website:
http://www.accme.org/index.cfm/fa/alerts.detail/alert_id/d43685f0-0218-4c77-906c-f18ae16f24bf
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