Two recent articles this past week highlight issues that question the validity of FDA approval of new drugs. This is on the heels of the spotlight on Big Pharma’s efforts to circumvent the Hatch-Waxman provisions designed to encourage generic company challenges to weak drug patents, and alleged abuse of the citizen petition process. In sum, one might be left wondering if the politics (read $) of new drugs and Big Pharma have overshadowed legitimate government functions of approving safe drugs and preserving patent rights for only the truly innovative.
The New York Times reported Monday that scientific advisors to the review process may have conflicts of interest that may jeopardize the integrity of the approval process. According to the article, critics have “complained for years” that those who sit on FDA approval boards often have “deep financial ties to drug makers.” The FDA often relies heavily on advisory boards for making decisions regarding drug approval. As a result, advisory board recommendations can have great influence on both the approval of the drug, and the stock price of the company that manufactures the drug. According to the FDA, however, finding qualified scientific advisors without financial ties is not as easy as it sounds.
Regardless, the FDA is currently debating new rules that would serve a policing function for who can sit on advisory boards. One proposed mechanism would be to exclude advisors who are paid directly by drug maker’s marketing departments. That seems to be a fair start.
Reuters, in an article posted last Friday, reports results of a somewhat alarming survey conducted by the “liberal-leaning Union of Concerned Scientists.” The study reports that about 15% of FDA scientists say they have been “wrongly asked to withhold or alter information or their conclusions in agency documents.” 17% said that they had been asked to report incomplete, inaccurate or misleading information to the public, industry, or other government officials. Perhaps most surprising, a stunning 40% said they feared retaliation if they “voiced concern about product safety in public.” While these numbers are indeed unsettling, one has to wonder whether there is any basis in FDA spokeswoman Susan Bro’s comments that the survey was a “counter-productive exercise based on leading questions and innuendo.”
Regardless, in light of Big Pharma’s recent practices of marketing branded drugs as generics (so-called “authorized generics”), paying generic manufacturers to stay out of the market during infringement litigation (“reverse payments”), and the alleged misuse of citizen’s petitions by drug manufacturers, my view would be that the FDA would be best served by keeping its nose clean while the ruckus dies down.
