FDA Whistleblowers Appeal for Help
It has been reported over the last couple of days that FDA senior management - presumably the Office of Chief Counsel - has escalated its crackdown on nine scientists who have revealed perceived and serious irregularities in the FDA's medical device approval process. According to the most recent report from the New York Times, the scientists charge that "agency officials have acted illegally and that patients are routinely put at risk from high-risk medical devices that are approved for sale even though manufacturers have never proven that the products are either safe or effective."
Given that the Supreme Court, in Riegel v. Medtronic, upheld preemption against civil liability in the class III medical device arena, these charges become especially ominous. If, indeed, FDA cannot be relied upon - and the possibility of lawsuit is removed - patients are effectively left without protection or recourse.
Earlier reports, including some references in the very recent GAO assessment, suggest the reviewers' charges may, indeed, be well founded. It is also extremely unusual for the FDA's Office of Criminal Investigations to initiate action against FDA personnel. Established after the generic drug scandal, the OCI generally handles issues of manufacturing fraud, gross misbranding, and counterfeit medications. For the OCI to be deployed as an internal "enforcement squad" also deserves serious attention.
There may, indeed, be criminal action to be investigated, but it remains unclear whether the perpetrators are the the reviewers or their managers or a more complex mix. The case has already been brought before the House Energy and Commerce Committee.
It is the opinion of this writer that there should, indeed, be the fullest and most transparent investigation of all parties involved in this dispute. And that if, indeed, the OCI is using, or has used, its resources to investigate FDA reviewers that fact itself deserves serious scrutiny through Congress and, potentially, an independent special prosecutor, Acting Commissioner Frank Torti, and Health and Human Services Direct Tom Daschle. If it is necessary, the intervention of the White House, as requested by the reviewers, does not appear unwarranted.
We have learned that during the Bush administration there appear to have been close consultations between the President's advisors and the FDA's Office of Chief Counsel, particularly regarding preemption initiatives. A recent report in the Wall Street Journal, for example, noted that the Office of Chief Counsel, responding to FDA career staff who questioned preemption arguments, replied that the 2006 labeling guidelines would not go through without the preemption preamable, "this per the White House."
The New York Times article can be found at: