Friday, January 30, 2009
Medical Needs of 6.2 Million U.S. Kids Go Unmet
Dems near win on child health bill
The Truth About 'Bio-identical' Hormone Therapy
FDA Warns Consumers Against Dietary Supplement Containing Undeclared Drug
F.D.A. Approves a Stem Cell Trial
Zimbabwe cholera cases top 60,000: U.N.
Another development within the realm of Healthcare and Big Pharma continues the recent trend to turn the focus of these businesses back to the well being of the consumers. The FDA recently announced a partnership with WebMD that will enhance the consumer’s ability to get the most recent information regarding all FDA monitored items including food, drugs, and cosmetics. As seen on the FDA News announcement letter, the partnership includes:
- A new online consumer health information resource on WebMD.com(www.webmd.com/fda): Consumers can access information on the safety of FDA-regulated products, including food, medicine and cosmetics, as well as learn how to report problems involving the safety of these products directly to the FDA. In addition, WebMD will bring the FDA public health alerts to all WebMD registered users and site visitors that request them. The cross-linked joint resource will also feature FDA’s Consumer Updates—timely and easy-to-read articles that are also posted on the FDA’s main consumer Web page (www.fda.gov/consumer).
- FDA contributions to WebMD The Magazine: FDA Consumer Updates will also be featured at least three times a year in WebMD’s bimonthly magazine, which reaches nearly nine million consumers. The magazine is distributed to physician’s office waiting rooms across the country.
FDA Teams With WebMD For New Online Consumer Health Information New Partnership to Inform and Educate Tens of Millions of Americans, http://www.fda.gov/bbs/topics/NEWS/2008/NEW01918.html
FDA Teams with WebMDDecember 3, 2008, http://www.healthdatamanagement.com/news/FDA_WebMD27389-1.html
Thursday, January 29, 2009
A question has come up from various manufacturers regarding the time limits on states to submit Medicaid invoices to manufacturers. According to the original Medicaid Drug Rebate Operations Guide, states were required to submit invoices no later than 60 days after each rebate period. Several of my colleagues, who previously worked processing Medicaid invoices, remembered receiving invoices several years after the fact. Several manufacturers have started receiving state invoices much older than 60 days, so there has been some question about whether CMS had actually amended this requirement since 2005. Have you noticed that you are also receiving invoices later than 60 days after each rebate period? If so, have you asked the states why?
CIS recently contacted the CMS MDR Operations Department with this question to get some clarification on the subject. CMS responded as follows: “Initial invoices are sent within 60 days. Invoices to account for changes/corrections may be submitted at any time and for as long as the MDR Program has been in existence.” So with this said, what could be causing all these prior quarter invoices to be sent?
CIS’ opinion on this subject is that since “The Final Rule” dictates that states are now required to submit invoices for J-Code products, many of them are likely submitting J-Code invoices retroactively as well, which is creating an increase in invoices for many prior quarters. CIS feels the increase in J-Code invoices will increase over the next few quarters, and then start to filter out as the states catch up on submitting the retroactive invoices. So when you receive invoices from the states, pay special attention to the invoice dates. If you feel that invoices were sent after their 60 day rebate period expired, contact the states to find out why.
If you would like to discuss this issue further, feel free to contact Barb Lutz any time!
CMS Releases and the Final Rule can be found at our PCX website: http://www.cis-pcx.com/
Wednesday, January 28, 2009
This is a pretty interesting topic (the FDA hasn't taken a "soft line" on very much lately), so two of our CIS bloggers decided to tackle the story: one to explain the new guidelines, and one to discuss their potential implications. Enjoy!
FDA Eases Off-Label Rules
By: Amy Lotman, CIS Senior Compliance Consultant
New guidelines established by the U.S. Food and Drug Administration (FDA) will allow drug manufacturers to tell doctors about unapproved – or "off label" – uses of their medications.
The finalized guidelines will allow pharmaceutical and device company reps to distribute journal articles to doctors about off-label uses of their products. The new recommendations are a finalized version of the draft about "good reprint practices" first issued in February 2008.
The guidelines do contain certain conditions:
- Reps are not allowed to discuss the journal article with the physician during the sales visit.
- The article must also be published by an organization that has an editorial board and uses experts in the subject under review.
- The article must not be in the form of a special supplement funded by the manufacturers.
- The information must be unabridged and not manipulated by the manufacturer in any way.
- The reprints must contain a "prominently displayed and permanently affixed statement" noting the uses discussed are not approved by the FDA.
The FDA states that the reprint, article, or reference publication should not be false or misleading and not pose a significant risk to public health if relied upon. Excluded from distribution are letters to the editor, journal abstracts, and reports of phase 1 trials in healthy subjects.
The distribution of journal articles about the off-label use of drugs had been allowed previously, although the legal provision expired in 2006.
By: John Jordan, CIS Compliance Specialist
Health officials have released guidelines that allow manufacturers to inform doctors of the unapproved uses of their medicines. The Food and Drug Administration new guidelines now allow drugmakers to distribute medical journals that describe various unapproved uses of their drugs. This news was announced on Monday, January 12.
Many are predicting that this can lead to doctors writing even more off-label prescriptions to their patients. Off-label use is when a drug is used for purposes not approved by the FDA. This is not an uncommon practice used by doctors. As Lisa Richwine states in her article, “Unapproved use of medicines is common. A doctor may prescribe an antidepressant, for example, to treat insomnia, or a cancer drug for a type of cancer beyond what is approved. About one of five prescriptions in the United States was written to treat a condition for which the drug was not approved, according to a 2006 study published in the Archives of Internal Medicine. The researchers said most off-label use occurs without scientific support.”
Alan Bennett, an attorney representing various manufacturers, states, “Handing out journal articles on off-label uses had been permitted under a legal provision that expired in 2006. The new guidelines "will clarify how and when manufacturers can provide unbiased, unembellished articles from peer-reviewed journals to health care professionals.” The FDA does hope, however, that the companies do seek FDA approval for the various uses for their medicines, instead of relying on off-label uses.
However, some are arguing against this new policy. They think it will allow companies to promote uses of their drugs without the proper testing. Rep. Henry Waxman, chairman of the House of Representatives Energy and Commerce Committee states, "This fundamentally undermines the requirement that companies prove to FDA that each new use is safe and effective. I hope this policy will be carefully re-examined by the new administration.” By law, manufacturers are not allowed to market unapproved uses of their medicines.
Both arguments have made valid points. They seem to be both looking at what is best for the patient. In my opinion, the goal should be to do whatever is necessary to save lives. The doctors should be knowledgeable on the drugs they are prescribing and use that knowledge to give the patient the medicine that is best to beat whatever problems he or she might have.
Tuesday, January 27, 2009
The Office of the Inspector General published its Annual Performance Report on January 16, 2009 (available on the PCX at 2008 Annual Performance Report). This report provides information on the performance and progress in achieving the goals established in last year’s Annual Performance Plan.
Before delving into the Performance Report, let’s remind ourselves of who the OIG is and what it does. The OIG is a government agency created to “protect the integrity of Department of Health and Human Services (HHS) programs, as well as the health and welfare of the beneficiaries of those programs.” [i] The OIG investigates fraud by conducting audits, detailed investigations, and inspections. The OIG is what I like to call the “fraud police.”
The findings (Advisory Opinions) of OIG investigations are made public on the OIG website.[ii] Advisory opinions are legally binding on the company for which they were written, because they are based on legal standards applied to a distinct set of facts, similar to case law developed by a judge. How they differ from case law is that they will not technically set legal precedent (opinions cannot be applied to and bind third parties), but they do provide guidance for other companies about the intentions and expectations of the OIG. So, similarly situated companies should take heed.
After an investigation, and as a result of a settlement, the OIG may negotiate a Corporate Integrity Agreement (CIA). CIAs act as binding agreements between the OIG and another healthcare related entity (i.e., healthcare provider or manufacturer). If the entity participates in one of the Government Programs (i.e., Medicaid) and abides by the CIA, then the OIG will not exclude the entity from participation in the Program. [iii]
The OIG also, from time to time, publishes guidance that manufacturers are urged to follow; the most notable guidance document is the “OIG Guidance for Pharmaceutical Manufactures of 2003.”[iv] It sets forth the OIG’s expectations, but it is not legally binding. CIS always recommends that our clients use this document as a guide, because if the OIG comes knocking on your door and finds that your company is significantly deviating from these expectations, they will inevitably find some sort of fraud or misconduct under the law (i.e., False Claims Act).
So back to the Performance Report…
The purpose of this report is to illustrate the collaborative nature of the OIG and other agencies (i.e., the Department of Justice, Medicaid Fraud Control Unites, local law enforcement) necessary to reach the goals set for the previous year’s report. This report summarizes HHS receivables, audit recoveries, return on investment, and other performance results.
The following is a summary of the most significant findings taken directly from the report:
“In FY 2008, OIG’s contributions to safeguarding HHS programs from threats of fraud, waste, and abuse and to promoting economy, efficiency, and effectiveness in HHS programs included:
- $2.35 billion in HHS receivables were court ordered or agreed to be paid through civil settlements that resulted from cases developed by OIG investigators;
- $1.33 billion in audit recoveries were agreed to be pursued by HHS program managers as a result of OIG audit disallowance recommendations;
- The return on investment measuring the efficiency of OIG’s health care oversight efforts continued its trend of increasing returns and reached $17 to $1 in the reporting period ending in FY 2008; and
- HHS program managers accepted and agreed to implement 85 of OIG’s quality and management improvement recommendations.”[v]
The report also includes a number of audits and investigations that significantly contributed to these recoveries. I won’t go into those here, but I urge you to read the report, understand the trends, and prepare for 2009!
[v] OIG 2008 Annual Performance Report “Message from the Inspector General”
[vi] OIG 2008 Annual Performance Report, Page 5
Monday, January 26, 2009
On a whim, and at the last moment, I hopped on a plane and went to Washington, DC for President Obama’s inauguration. I didn’t have a ticket to the actual event but just wanted to be there. I couldn’t express the reasons for this feeling, just knew that it was an important and historical event – to me and to the country. I was happy to hang out with “the masses,” maybe sit on the steps of the Lincoln Memorial and watch the events on the Jumbotrons strategically placed around the National Mall. I just wanted to go and “experience” the event.
On Tuesday morning, I took a shuttle from the hotel to the Metro, and found out that late Monday afternoon the Congressional Offices had handed out tickets that had not been picked up by attendees. Everyone else on the shuttle had tickets and they were understandably thrilled about the opportunity, especially the kids. As I talked to the people on the shuttle, a lady from one of the families turned to me and said, “Here, you can have this.” It was a ticket to the restricted area! It turns out that her friend had not shown up so she had an extra ticket for the standing area was generously giving it to me. I was almost speechless, but did manage to say “Thank You” through my tears.
I finally got to the Mall around 7:15 AM, and after a number of mishaps, bad directions, crowded entrance points and other moments requiring patience beyond what I ever thought I was capable of, I got to my ticketed viewing area around 10:45.
I still had to view the events on a Jumbotron since I was at least 100 yards away, and there was scaffolding for the cameras directly in front of the area where the speakers and President Obama stood. I did, however, get a great “big picture” sense of the event and my photos were much better than they would have been from the Lincoln Monument, a mere two miles away.
So if I couldn’t see clearly what was happening, you might wonder if it was worth the time, energy and expense. Unequivocally, the answer is, “YES!” But “Why?” is a difficult question to answer. I have struggled to articulate everything surrounding the event, including: Why was it so important for me to attend? What was it like? I am not normally at a loss for words yet these are questions that have been difficult to answer, despite my numerous attempts.
The day was many things simultaneously. Crowded, cold, logistically frustrating, full of camaraderie – these are the first descriptors that come to mind. I have heard there were an estimated 1.8 million people at the event, but not one arrest. I don’t know if this is true or not but if it is, I am not surprised. It just wasn’t a day for animosity but one about hope, change and new beginnings.
Depending on one’s age, race, culture, ideological beliefs and life experiences, President Obama represents different things to each of us. I believe his unlikely path to becoming president, combined with his message of hope and inclusiveness, resonate with many Americans and even with many citizens of other countries. During and after his campaign, he somehow made the future personal. Those of us who supported him, and maybe those who didn’t, feel like we have a stake in the future, not just of our own but of our shared future as a nation, and not just a stake, but an obligation to help shape its outcome.
While reading The New York Times, I saw the following quote about the event that struck me as the most accurate description:
“There was something very private and almost personal about being here ...” (Attributed to Tiajuana Lee, The New York Times, “From a Festive Crowd Come Chants and Tears,” Page P1, January 21, 2009)
How do 1.8 million people have a shared yet private and personal experience? And how can President Obama’s inauguration be a private or personal experience for so many people? For me, being there may have contributed to the feeling that it was about me, but I believe the reverse was true. My need to be there was actually a result of believing that the day was, at least partially, about me. President Obama continually stresses how he cannot do everything alone. Therefore, it is about me, but in a different way than we have seen in recent years in the United States. “What do I want?” is still a question being asked, but maybe more importantly, “What am I willing to do to make it happen?” is also becoming part of the dialogue. I hope this question does not fade into the background as the glow of the excitement and enthusiasm of this occasion wears off. Let us not end up back where we had previously been, waiting to see what the politicians do for us, and months or years later, wonder why things did not turn out any differently.
Thursday, January 22, 2009
This is a full day session, running concurrent to the MDRP 101 session. Despite the fact that it is listed as "B2 Government Programs Fundamentals" on the IIR website, this is no introductory session.
The workshop covers advanced topics across Medicaid, the VA Program and PHS. It brings together industry professionals, agency representatives, and law firms, providing an alternative forum for people with industry experience who need more than just MDRP 101.
This format came together as people came to both IIR and CIS with requests to cover more advanced topics and discussions. Our approach is to facilitate discussion in a workshop format, where we can engage participants in open discussion, share real life experiences and discuss common issues and challenges – so you will not see a lot of PowerPoints!
CIS is committed to working with industry GP professionals to develop forums and venues for thoughtful and engaged discussion across government programs, discuss topical and challenging issues, and facilitate increased dialog between industry, agencies, law firms and consulting professionals.
We hope that you are able to participate in this session, and we welcome your thoughts and questions in advance!
For more information or to register for this workshop, please click here .
If you have questions, or if you are unable to attend but would like a summary of the workshop, please contact CIS Practice Lead and VP of Regulatory Compliance Chris Cobourn, at email@example.com.
We hope to see you next month!
Wednesday, January 21, 2009
On January 14, 2009, the FDA announced the launch of the Secure Supply Chain pilot program. The FDA believes the new voluntary, two-year pilot program will help promote the safety of drugs and active drug ingredients produced outside the United States, and brought into this country for sale and for use in drug manufacturing. The goal of the pilot program is to determine the feasibility of developing a permanent Secure Supply Chain into the United States.
If the pilot program is successful and indicates that a permanent program is feasible, the Secure Supply Chain would assist the agency in its efforts to prevent the importation of drugs that do not comply with applicable FDA requirements.
A successful program would allow the FDA to accomplish the following:
- Aid in preventing the importation of drugs and drug products that do not meet the current FDA requirements ;
- Allow the agency to focus its resources on foreign-produced drugs that fall outside the program and may not be compliant;
- Expedite the importation of drug products that meet pilot program criteria;
- Aid in mitigating the risk of contaminated or counterfeit drugs entering the US supply chain.
Initially, the FDA plans to select 100 applicants to participate in the Secure Supply Chain pilot program. To qualify, companies must meet certain criteria, including the requirement that manufacturers have control over their drug products, from manufacture through their entry into the United States. Each applicant may designate up to five (5) drugs for selection into the pilot program, provided:
- The applicant holds an FDA-approved drug application, or is the foreign manufacturer in an FDA-approved application;
- The active pharmaceutical ingredients imported are used only to make FDA-approved drugs;
- Foreign drug manufacturers and U.S. establishments receiving drugs are FDA-registered, and compliant with Good Manufacturing Practices;
- Applicants show that their drug products use a secure supply chain.
Deborah Autor, Director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research (CDER) was quoted as saying, “This initiative creates incentives for drug makers to develop and maintain secure supply chains. This is one of several agency initiatives to enhance drug product safety.”
Michael Chappell, acting Associate Commissioner for Regulatory Affairs at the FDA, was also quoted in the press release as saying, “With the increase of drug products produced outside the United States, it is critical that the FDA concentrate its resources on companies that pose the highest risk of importing products that don’t meet the FDA’s standards and violate U.S. Laws. Consumers should know that only companies that maintain control over the products will be selected into the pilot programs.”
Companies that would like to participate will be processed in a first come, first served basis. There was no mention of whether the participants and products for the pilot program will be made public.
The application for the program can be found at: http://www.fda.gov/cder/fedreg/fda-3676.pdf
The federal register notice can be found at: http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-N-0656-N.pdf
Source: FDA News Releases
Tuesday, January 20, 2009
As President-Elect Barack Obama prepares to officially become President today, there is no doubt that he faces numerous challenges ahead. However, he can feel positive about the fact that the House of Representatives has passed a bill impacting one of his key agenda items – health care. On Wednesday, January 15, the House passed a children’s health care bill, which will provide an additional 4 million children with government sponsored health care coverage.
The program being expanded is the State Children’s Health Insurance Program (SCHIP), which was initiated during President Clinton’s administration and provides health care coverage to children at or below the poverty level who do not meet eligibility for Medicaid. Currently approximately 7 million children are covered under the program. The new House bill extends coverage to an additional 4 million children of working families, who previously did not meet the eligibility requirements. This expansion of SCHIP is estimated to cost $33 billion over a timeline of approximately 4 years. The bill calls for an increase in the federal cigarette tax ($0.61 per pack) to pay for the expansion of the program.
The Senate has begun reviewing its own version of the bill, estimated to cost less than the House bill at $31.5 billion over the same timeline. One of the key differences is coverage for children of recent legal immigrants. Under the House bill, recent legal immigrants may be accepted into the program rather than waiting the currently mandated 5-year period. The Senate version does not provide for this, but such a provision may be added as the bill progresses.
The House bill, while passed by a 289-139 vote, faced significant opposition from Republicans. Among the concerns expressed are the inclusion of immigrants, the expansion of government-run health care, and the inadequacy in addressing the problems inherent in the Medicaid system. Nevertheless, the passing of the House bill provides reassurance and hope to many Americans as struggling states cut their Medicaid budgets. While still a long way from Obama’s ultimate goal of universal health care coverage, the passing of the bill can be viewed as a start in the right direction.
House Bill H.R.2
The Washington Post
The Wall Street Journal
Monday, January 19, 2009
Just a few weeks into the New Year, there are already so many blog-worthy news events that I couldn’t choose just one to write about. Here are some fascinating stories to think about that have been published in 2009.
1. Americans were the top spenders on prescription drugs in 2005, the most recent year that has been analyzed. “U.S. patients shelled out an average of $792 each for their meds in 2005, almost double the overall average among all industrialized countries. That average was $401, a number that not only depends on drug prices, but on per capita consumption of them” (1). So even with the slower economy and a shift toward lower priced generics, our spending was greater per person than in any other country.
2. Overall, healthcare spending in the U.S. grew by 6.1 percent in 2007, the slowest growth rate since 1998. “Health care spending, however, continues to outpace overall economic growth, which grew by 4.8 percent in 2007” (2). Healthcare spending accounted for 16.2% of the nation’s gross domestic product (GDP) in 2007, or $2.2 trillion, which comes out to $7,421 per person (2).
3. Seven hospitals filed 14,000 fraudulent Medicaid claims between July of 2002 and the end of 2006. The “hospitals in New York State are accused of bilking Medicaid of some $50 million” (3). One hospital, which closed in November, allegedly paid its employees to go to homeless shelters to lure people into entering detox programs. The hospital workers offered the homeless free beer, cigarettes and food for attending a three day program, and then billed Medicaid for their stays (4). The other hospitals fabricated and exaggerated records so their patients were eligible for the hospital’s detox programs, which did not have the correct state operating licenses needed to run the programs. There was no filing of “criminal charges, but authorities can collect triple the financial damages in civil cases and can also close a facility” (5).
4. As of January 1, 2009, forty drug manufacturers signed an agreement to stop distributing free goods, such as pens, staplers, shirts and mugs to doctors. “The guidelines also reiterate the [Pharmaceutical Research and Manufacturers of America] 2002 code, which prohibited more expensive goods and services like tickets to professional sports games and junkets to resorts. And it asks companies that finance medical courses, conferences or scholarships to leave the selection of study material and scholarship recipients to outside program coordinators” (6). The new code will hopefully encourage the educational relationship between industry and doctors, and restore public confidence that doctors aren’t being persuaded to prescribe higher priced drugs.
Wednesday, January 14, 2009
As most of our readers have probably already learned, Pharmalot closed its electronic doors last week. Manager/editor/everything else Ed Silverman accepted a buyout from the blog’s owner, The Star-Ledger of New Jersey.
For the last three years or so, Pharmalot was part of the daily routine of anyone and everyone who followed the pharmaceutical industry. It will be missed. Since it shut down, I’ve drowsily clicked on my Pharmalot bookmark first thing in the morning on more than one occasion and been disappointed to find the goodbye message staring back at me. I still haven’t deleted the bookmark, though.
According to several different sources, Ed Silverman will soon be working for Elsevier, presumably covering some of the same subjects he covered so ably at Pharmalot. We wish him good luck, and we expect good things. Soon. We’re very demanding here at the Pharma Compliance Blog.
And, lastly, I apologize for the headline – at the PCB, we just can’t resist a good pun. Or a really, really bad one.
Tuesday, January 13, 2009
OIG Audit Readiness: Understanding, Developing, and Implementing a Practical and Meaningful Government Programs Audit Plan
January 14, 2009
1:00 PM – 3:00 PM, EDT
Your Webinar Leaders:
· Chris Cobourn, Vice President of Regulatory Compliance, Compliance Implementation Services (CIS)
· Clarissa Crain, Senior Compliance Specialist, Compliance Implementation Services (CIS)
· Jim Jaakobs, MBA, CPA, Manager of Government Contracting and Pricing Compliance, JOHNSON & JOHNSON
1:00 - Webinar Introduction
· Explaining why Government Programs is a high risk area
· A brief history of GP related audit and investigations activity, and where the trends are going
· Discuss the legal framework for GP investigations
· Discuss the principal of voluntary restatements, within the framework of each agency
· Understanding audit terms: what is Monitoring and Audit?
· How are Monitoring and Auditing distinguished from one another?
· Who is responsible for Monitoring and Auditing Functions?
· What is the risk of not developing appropriate Monitoring and Auditing?
· Identifying your areas of risk
· How do you assess current business processes and practices for risk?
· What are key considerations related to product portfolios, company structure, and commercial strategy that impact risk and audit readiness?
· Developing a framework for audit readiness
· How do you evaluate existing controls, monitors, and audit functions?
· How do you develop meaningful monitoring and auditing functions across various organizational structures and size?
· What type of skill sets and resources are required for auditing?
· For existing monitoring and auditing functions, how do you evaluate their effectiveness?
· What should you establish as the frequency of monitoring and audit?
· Getting senior management support for audit readiness, whether you are big pharma or an “army of one” at a small company
· How do you communicate risk and the need for proactive identification of gaps or potential compliance issues?
· How do you overcome the lack of independent internal auditors possessing sufficient GP expertise to audit the area?
2:30 - Questions from Audience
3:00 - Webinar Concludes
5 Easy Ways to Register
Mail: ExL Events, Inc., 555 8th Ave., Ste. 310, New York, NY 10018
Online : http://www.exlpharma.com/
* When registering, please use priority code P225EM6
For more information please contact Pam Sobotka at firstname.lastname@example.org
Thursday, January 8, 2009
I often tend to take a step back and think about the “big picture” from time to time. Well, last night while watching news reports on our new president-elect, I began to think generally about the pharma industry. Yes, I know. Many bloggers have already posted their thoughts in past weeks, but a lot has happened since, and this post will attempt to recall my thoughts, which are heavily influenced by the media at this point and thus mostly speculative.
There are three variables to consider: FDA commissioner, patents, and generic drug manufacturers. The next three years will be hectic in the industry, for lack of a better word. Many of the blockbuster drugs, which generate billions of dollars in revenue, will be coming off patent. In addition, there are few novel drugs in the pipeline to replace the loss of blockbuster patents. Many companies have anticipated this and are allocating money into generics, or funding genetic therapies research, or both. It follows that the larger generic companies, like Teva, will see a substantial increase in revenue throughout this time period.
Now let’s look at the likely candidate for taking over the FDA. A recent report shown here indicates that Obama and his administration are favoring former commissioner, Dr. Jane Henney. Dr. Henney has a solid rapport within the industry as she was well known to not only reduce the drug approval process but also made it more flexible for manufacturers. As a result, it is likely that we will see more approvals under Dr. Henney. That could be good news for the industry as a whole. On the other end, the Obama administration will most likely be “pro-generic” for the simple fact that they are more affordable.
I’m going to try and tie all this together now. We have a potential commissioner who is known for speeding up the drug, approval process. We have blockbuster patents ending and generic manufacturers salivating over them. We also have a new administration that will most likely be pro-generic. What does all this mean? Well I think that if Obama is truly considering Dr. Henney, then we will absolutely see an increase in approvals, but for generic, not necessarily novel drugs.
Tuesday, January 6, 2009
Everything in our world today runs at a fast pace, and the pharmaceutical industry is certainly no exception. In order to stay competitive in the market, pharmaceutical companies are pushing hard to develop and promote new drugs faster than ever before. The problem is that this fast-paced development shifts the focus from patient safety to creating revenue.
Several horror stories of drugs being placed on the market too soon, only to be quickly withdrawn, are well familiar: Vioxx, the anti-inflammatory drug associated with causing heart attacks and strokes, was withdrawn in 1999; Baycol, the cholesterol-lowering drug associated with adverse muscular reactions, was withdrawn in 2001. But those aren’t the only examples. Almost a decade later, the trend of sending insufficiently studied, and sometimes dangerous, drugs into the market continues.
Withdrawing a product from the market, whether voluntarily or not, can hurt a company’s reputation in many ways, but the bottom line is that a withdrawal causes consumers to lose faith in the company and all of the products that it manufactures. This translates into, at best, a loss of revenue and at worst, costly litigation. So how can companies develop new drugs, but avoid the possibility that they could be withdrawn from the market?
One of the main criteria the FDA looks for when approving a new drug is whether it is safe, and whether the benefits outweigh the risks. The finger of blame could possibly be pointed at the FDA for approving drugs too quickly, but it is also the responsibility of pharmaceutical manufacturers to provide the FDA with all information available to make its decision. If drugs are not being sufficiently examined within the appropriate test groups, then it is impossible to give the FDA the information it needs to make a responsible decision. Many studies have shown that the FDA is underfunded, and because of the Prescription Drug User Fee Act (PDUFA), it must review 90 percent of all drug applications within 10 months of submission, or face further funding reductions. This puts pressure on the FDA to make potentially hasty decisions, so it is up to manufacturers to present the most thorough information possible, to assist the FDA in making the best approval decisions possible.
How should the “most thorough information” be obtained? Common sense would tell us that the best way to avoid product withdrawals is to design clinical trials that focus on short AND long-term side effects in patients. A study published in the Annals of Oncology researched 25 clinical trials over a ten year period, and found that each lasted around 30 months once benefits were found in patients. As stated above, the FDA needs to look at the benefits compared to the risks. If clinical trials are cut short just because there are promising benefits, it would be difficult to assess potential long-term risks, which could lead to the FDA approving a drug too soon.
Despite the push to developing drugs faster than ever, the human body is not something that can be rushed. In order to avoid the negative impact that a product withdrawal creates, manufacturers should focus more on long-term testing of associated risks, and less on developing drugs too quickly in eagerness for revenue. Sometimes the best way to stay competitive is to slow down instead of speeding up.
Monday, January 5, 2009
I hope you all had a wonderful holiday season and a welcome respite from work (I sure enjoyed taking a short break from the PCB)! I'm sure you're all back in the office and 100% focused on the tasks at hand, but just in case you need a short break, here's an uplifting look at what we actually accomplished in 2008.
Dana Zelig, CIS Compliance Specialist and PCB Editor
A Look Back at 2008: A Year of Firsts
By: Karen Agama, CIS Compliance Consultant
The year is ending with plenty of room for improvement, so rather than replay the disheartening events that are so familiar to anyone with access to the outside world, I thought it would be much more fun to celebrate a few milestones.
January: Bobby Jindal, the first Indian American governor in U.S. history, takes office as the 56th governor of Louisiana, earning praise among residents disillusioned with the government as bright, capable, and energetic.[i]
February: As Pyonyang shuts down its nuclear reactor in Yongbyon, the New York Philharmonic becomes the first American musical ensemble to perform in North Korea and the largest American contingent to visit Pyonyang since the end of the Korean War.[ii]
March: David Paterson succeeds fallen Governor Eliot Spitzer, becoming the first African American governor of New York, and the first legally blind person to serve as governor of any state.[iii]
April: Danica Patrick becomes the first female winner in any first-rate American motor racing series with her IndyCar victory in the 2008 Indy Japan 300.[iv]
May: A team of astronomers, led by Hubble and Carnegie-Princeton Fellow Alicia Soderberg, catches a star in the act of exploding (a supernova) for the first time with NASA’s Swift satellite.[v]
June: Illinois Senator Barack Obama becomes the first African American to be nominated for election to the U.S. presidency by a major political party.[vi]
July: Kuwait names former army chief of staff Ali-Momen as its first ambassador to Iraq since the Gulf War. Momen heads a center in Kuwait that partners with the UN to provide humanitarian aid to Iraq.[vii]
August: At just 23 years old, and despite having attention deficit hyperactivity disorder (or partly because of it?), Michael Phelps wins eight gold medals in Beijing and becomes the most successful single-Games Olympian of all time.[viii] [ix]
September: Condoleeza Rice becomes the first U.S. Secretary of State to visit Libya since 1953, reopening diplomatic relations.[x]
October: Okay, so this is a “second,” not a “first,” but definitely worth celebrating! The Philadelphia Phillies win the World Series for the second time in their 125-year history (their first win was in 1980).[xi]
November: Democrat Barack Obama wins the 2008 United States presidential election, becoming the first African American to be elected to the office of President of the United States.
In reflecting on the larger picture, even though we’re facing some pretty troubling news of late, remember that the American spirit has brought us to this place, where we can celebrate these remarkable firsts. With that enduring will and determination, I have confidence that we will rise to our present challenges, as well. Life is what we make it, and we can all make it better each year, together.