FDA Drug Approval Panel Members Rewarded by Pharmaceutical Companies
While the U.S. Food and Drug Administration (FDA) has a system in place to identify potential conflicts of interest among members of advisory panels that recommend for or against drug approvals, an investigation published on July 5, 2018 in the journal Science revealed that some of these advisors have received paid reimbursements by pharmaceutical companies for services performed after a drug has been approved.1
According to the FDA's website, advisory committees provide the agency with independent opinions from outside experts concerning new drugs. After receiving copies of the FDA's review of the documents and information concerning the applications, the committee members may recommend approval or disapproval of a drug's application. While the FDA usually follows an advisory committee's recommendation, they are not obligated to do so.2
Charles Piller, who is a contributing correspondent in the News department at Science analyzed data from 2013-2016 on the U.S. Open Payments website for his investigation. He found that 40 out of 107 physician advisors who were members of drug approval committees received over $10,000 in post hoc earnings or research contributions from the pharmaceutical companies whose drugs the committees approved or from competing companies. Seven of these advisors received over 1 million dollars. In addition to delayed incentives, Piller found that many panel members receive financial compensation for consulting, lectures, or research during the year leading up to the advisory meetings.
"The people who are asked to weigh this evidence impartially often stand to gain tremendously in their further professional careers from a positive relationship with the company," explained Oregon Health & Science University hematologist-oncologist Vinay Prasad who studies financial conflicts in drug approvals. "It's in their best interest to play nice with the companies."
"When your No. 1, major employer after you leave your job is sitting across the table from you, you're not going to be a hard-ass when you regulate," he added. "That's just human nature."
Similar to outside advisers, regular FDA employees are often subsequently employed by the companies they previously regulated.
The current investigation also raises questions about how well the FDA enforces the more traditional conflict rules that include disclosure of investments, contracts or other payments from drug manufacturers prior to being qualified as an advisor.
"Even in the best of circumstances, disclosure is a remarkably weak way of controlling conflicts of interest," commented Carl Elliott, who is a medical ethicist at the University of Minnesota in Minneapolis. "A better way would simply be for the FDA to say, 'We are not taking anybody with any kind of conflict on an advisory committee.'"
When the FDA was asked by Piller for commentary concerning the current findings, the agency declined.
References
- Science. 2018 Jul 6;361(6397):16-20.
- Human Drug Advisory Committees, U.S. Food & Drug Administration. 2017 Oct 5. https://www.fda.gov/advisorycommittees/committeesmeetingmaterials/drugs/default.htm
