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The Government Accountability Office (GAO) has completed a study of the effectiveness of the FDA and in testimony before Congress concluded.
"...these shortcomings in both premarket and postmarket activities raise serious
concerns about FDA's regulation of medical devices."
The highlights to the report to Congress from the GAO can be found here
The full report to Congress can be found here.
Great post.
ReplyDeleteIt’s been a long time coming, but a storm is brewing.
I think it can be pretty much concluded that any argument for preemption is done in support of industry protectionism above public safety.
ReplyDeleteIf you recall this letter written in October of 2008 to the
UNITED STATES HOUSE OF REPRESENTATIVES COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM
titled -
FDA CAREER STAFF OBJECTED TO AGENCY PREEMPTION POLICIES
The conclusion of the letter says -
III. CONCLUSION
Internal FDA documents provided to the Committee reveal that in 2006 and 2008, FDA promulgated drug labeling regulations that contradicted the advice of FDA’s high-ranking career officials. Publicly, FDA justified its preemption policies on the grounds that state lawsuits “could encourage manufacturers to propose ‘defensive labeling’ … [and] scientifically unsubstantiated warnings.” But, internally, senior FDA officials wrote that “[w]e rarely find ourselves in situations where sponsors want to disclose more risk information than we think is necessary”; that “[t]he entire argument … that sponsors are insisting on exaggerated statements of risk is naïve to what actually occurs”; and that “the whole argument that liability concerns drive inaccurate labeling is false and misleading.” They also stated that it was “unwise to suggest that FDA approved labeling is always up-to-date,” and that the requirement of prior FDA approval for labeling changes was “not consistent with agency’s role in protecting the public health” and created “the problem of how to get important new safety information into the labeling in a timely manner.”
FDA has an obligation to ensure the safety and effectiveness of drugs. In this case, however, the internal documents indicate that the Bush Administration weakened important drug safety regulations to shield manufacturers from liability. That is a serious abuse of the agency’s public health authorities.
That report only relates to FDA regulation of medical devices.
ReplyDeleteMarilyn Mann
Reports are useless. Who is going to take action? For example what happened to Waxman's 2007 sweeping investigation into Boston Scientific's and Cordis donations to Cardiovascular Research Foundation, based in new York, which in affiliated with all the major teaching hospitals, has strong ties with the FDA, despite the fact that they been looked at for using their Non-profit status to push stents for their own profit (leon).
ReplyDeleteWaxman may have been asked to quietly step aside. But we still have this report. better than nothing I suppose.
The point I was trying to make (poorly made) was that here again we see a major entity saying that the FDA is not able to do an adequate job of protecting the public.
ReplyDeleteThe more important point being that even in spite of this overwhelming and mounting evidence, proponents of FDA preemption continue to make arguments that are diametrically opposed to these facts. They brazenly propose that the FDA is capable, provides safe guidance, and should be the only entity watching the conduct our food, drug and medical device manufacturers.
I find this to be more and more observably deceitful support of industry concerns and deliberately blind to public safety.