As part of eleventh grade curriculum, students learn about checks and balances in the U.S. government. You may remember hearing about the Executive, Judicial, and Legislative branches of government with each branch keeping the others accountable and preventing one another from gaining too much power. But what about government agencies such as the FDA: is this department being influenced by big pharmaceutical companies and who is keeping this multi-billion dollar agency accountable?
In order to assess the relationship of the FDA with pharmaceutical companies, we must first discuss how the process of drug approval works. Here are the simplified steps:
There are many factors which are causing concern pertaining to the whether or not the FDA is truly unbiased when approving products, drugs, and medical devices. For instance, a current study was conducted by Dr. Vinay Prasad and Dr. Jeffrey Bien in which they tracked 55 FDA reviewers in the hematology-oncology field from 2001 through 2010. They discovered that about 27 percent of the total number of reviewers left their federal oversight posts to work for the industry they previously regulated. "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," Prasad said. "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]?"Additionally, since the pharmaceutical company submits reports and pays for doctors and scientists to review their medications, are these studies really impartial? According to Genevieve Pham-Kanter, assistant professor in the School of Public Health at Drexel University, maybe not. Pham-Kanter reviewed 15 years of data, from 1997 to 2011, and focused on 15 CDER committees. “The results of the research study found that members of the advisory committee with an exclusive tie to the sponsor company often favored the sponsor… another interesting finding is that, when board members were on the advisory board for the sponsor and that was their only financial tie, then they were significantly more likely to vote in favor of the sponsor.“Many FDA employees go on to work for the pharmaceutical companies they regulated and “impartial” doctors and scientists paid by pharmaceutical companies tend to favor on the side of the medication. Clearly the ties between the FDA and big pharmaceutical companies is strong and both need to be held accountable for the drugs that are being put on the market.
