In a recent BMJ article, investigators uncovered more than 25 percent of FDA cancer and hematology drug reviewers who left the agency between 2001 and 2010 now work or consult for pharmaceutical companies, according to Kaiser Health News. In the study, Portland-based Oregon Health and Science University researchers tracked 55 FDA reviewers in the hematology-oncology field from 2001 through 2010 by using LinkedIn, PubMed and other publicly available job data.
Researchers focused their efforts on hematology-oncology due to the large number of new drugs flooding the industry and the fact that reviewers have autonomy in this field. The researchers found, of the 26 reviewers who left the FDA in this time frame, 57 percent later worked or consulted in the pharmaceutical industry. While this practice is common, researchers note it does raise some concerns.
Lead researcher Vinay Prasad, MD, told KHN, "If you know in the back of your mind that your career goal may be to someday work on the other side of the table, I wonder whether that changes the way you regulate. Are you more likely to give [companies] the benefit of the doubt? Are you less likely to beat them up hard over [using bad comparisons in drug studies]?"
Joshua Sharfstein, MD, a former FDA principal deputy commissioner and associate dean at Baltimore-based John Hopkins Bloomberg School of Public Health, had a different take on the matter, saying reviewers do not have a wealth of power over approvals. Dr. Sharfstein said, "There are just so many checks and balances within the review process that it's really not up to one person by and large. Key regulatory decisions are looked at from many different angles. I think it would be very difficult for an individual to do something inappropriate and not have that caught."
Dr. Sharfstein argues having former FDA officials migrate to the pharmaceutical industry could benefit the public due to their extensive knowledge of the approval process. Their knowledge will make employees better equipped to ensure all the necessary research is completed and the pathways to approval are understood.
A FDA spokesperson said many former FDA employees work for many different agencies, saying, "The FDA has a strong set of rules in place to ensure that our employees are working in the public interest, not to advantage any company, organization or individual."
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