Who’s Watching the Doc?

By: Jon Dellaquila, CIS Compliance Manager
jondellaquila@cis-partners.com

Sponsor companies, the company supporting a clinical trial, within the pharmaceutical industry are constantly under the watchful eyes of government agencies responsible for the safety and well-being of the general public. These companies are expected to adhere to the highest ethical standards and have various procedures in place to support their activities. However, when a company is inspected by a government agency and found to have violated a specific regulation or law, the information is made public and garners significant media attention.

When companies are cited during an inspection and receive a warning letter (such as a 483), it is in their best interest to reply in a timely manner. In the event that a timeline for resolving compliance issues mandated by the FDA is not met by the sponsor company, the FDA has the right to enforce daily monetary fines against the company. [1] Sponsor companies are in complete control of their manufacturing and drug development processes, making them solely responsible for the products they produce. However, once clinical trials begin, an additional variable, the role of the investigator, becomes significant. Although companies have procedures in place to ensure they work with doctors who have no previous criminal activity, it is imperative that companies also have procedures in place to provide the proper oversight regarding investigator behavior.

An October 22 article published in the Wall Street Journal titled ‘FDA Slow to Debar Doctors Who Commit Crimes, Report Says’ should raise some eyebrows in the pharmaceutical community. In the report, it states that the FDA took 11 years to debar a physician who had been convicted of 53 counts of criminal offense, including concealing the attempted suicide of a clinical-trial patient and prescribing a drug without a license.[2] The government watchdog report also stated it takes the FDA on average, four years to debar a physician. Although the FDA does its best to oversee doctors, it is ultimately the responsibility of the sponsor company supporting the trial. Since the FDA debarment process is four years on average, it is imperative the sponsor companies ensure their clinical trial sites are being adequately monitored. The FDA does not have the resources to monitor every doctor on a day-to-day basis. Sponsor companies must do their part to ensure trials are not compromised and avoid any unnecessary issues or monetary penalties.

The FDA is working diligently to create positions to provide physician oversight. However, they are limited in their abilities to debar physicians. In fact, physicians who are barred from participating in a drug trial still have the ability to participate in a medical device trial and vice versa. [2] This further emphasizes the need for sponsor companies to ensure that their monitoring activities are adequate and any identifiable issues are being resolved. For instance, if a sponsor company lacked site oversight and a particular physician was found to have acted unethically and was debarred, the data gathered from that site for a trial would not be valid. This could significantly impact trial endpoints resulting in severe financial losses.

Time and time again it has become evident that it is in the best interest of the sponsor companies to do their due diligence and ensure they have the correct procedures and preventative measures in place to minimize compliance risks. Besides the obvious financial savings, it would also eliminate a lot of unnecessary headaches among employees. One could say, it literally pays to be inspection ready.

Sources:
[1] http://findarticles.com/p/articles/mi_qa5351/is_200006/ai_n21457185/
[2] http://online.wsj.com/article/SB125622345164801405.html