The FDA may be hitting a new low in terms of the image-bashing it has taken during the past six years. Today, the New York Times reports FDA Scientists Accuse Agency of Misconduct. One almost doesn’t want to read further, but like a train wreck, it is hard to look away.
A letter from FDA scientists to the Committee on Energy and Commerce alleges that the FDA knowingly approved devices that were unsafe or ineffective. The specific devices that are the subject of the letter are apparently not named, which will necessarily cause scrutiny to fall on all devices recently approved. Manufacturers, get your talking points lined up now.
The letter from the scientists to the Committee on Energy and Commerce was posted on the site of the Committee, omitting the names of the scientists who signed the letter. The allegations contained in it are fairly damning and the letter to the Committee follows a letter last spring sent by the scientists to Dr. Andrew C. von Eschenbach which was sent after the scientists approached leadership at the Centers for Devices and Radiological Health (CDRH). You can read the full letter for yourself, but this sentence kind of sums things up – "[t]here is extensive documentary evidence that managers at CDRH have corrupted and interfered with the scientific review of medical devices."
Naturally, this compels the Committee to investigate and they have sent a letter and issued a press release announcing their intention to do so and during the remaining days of this Congress, they want a briefing on the matter. The Committee already was holding FDA up to scrutiny in terms of the approval process, and this latest development surely adds a great deal of grist to the mill of those who would seek to remove the approval and safety functions of the FDA to make them completely independent of one another.
And, as the images of the FDA and the pharmaceutical industry are intrinsically linked, this is bad news for everybody. One can only hope it is the last vestige of the past six years and that incoming new leadership will be well equipped to turn the agency image around and restore it.