The FDA and the 99%

“Public Citizen again urges you to immediately withdraw this reckless and justifiably embarrassing proposed Guidance.” – Dr. Sidney M. Wolfe

Last June, the FDA issued draft guidance that would, as Sidney Wolfe of Public Citizen explains, “give drug companies free rein (the FDA ‘will not object’) to tell doctors that a medication is less dangerous than the FDA has concluded and is stated on the approved labeling.” “If finalized,” he writes, “the Guidance would allow pharmaceutical companies to inform health care providers that the FDA-approved labeling overstates a medication’s risks, by distributing peer-reviewed articles and by having discussions with doctors.”* In response, Wolfe published an article in JAMA Internal Medicine last August outlining the problems with the draft guidance.

Almost two months after the public comment period on the proposed guidance closed last August, the FDA had still posted only a single comment on their site. So Public Citizen filed a FOIA request, gaining access to all of the 1782 comments submitted. Of these, 1771 opposed the proposed guidance, while 11 approved. The 11 supporting comments came from drug industry groups or their representatives.

Last month, Wolfe wrote an open letter to HHS Secretary Sylvia Burwell summarizing the public response and urging her to withdraw the guidance. I haven’t found any news stories about developments since then, and there doesn’t appear to be any timetable or deadline for the disposition of the guidance, but a spokesperson for Burwell said at the time that “Secretary Burwell appreciates hearing from stakeholders” and that “The FDA is currently reviewing and considering all comments received from the dockets on the draft guidance.”

That review would seem fairly straightforward. I suggest a pie chart with a label indicating the source of the less than 1% of comments approving the guidance. And then some deep thinking about the public trust.

*These statements are from Wolfe’s March 11, 2015 letter to Sylvia Burwell.