Friday, June 30, 2006

As Premption Kicks In, FDA Gets Soft

FDA enforcement actions targeting safety problems and misleading claims have fallen sharply even though violations have not, according to statistics released Monday by Rep. Henry A. Waxman. His report is titled "Prescription for Harm" and can be found here. (PDF alert).

In 2005, the FDA issued 535 warning letters to companies, a 54% decline from 1,154 such notices issued in 2000. Over that time, the number of violations reported by FDA inspectors in the field fell only 1% — from 6,334 to 6,268. In reply, an FDA talking head said that the stats did not take into account the agency's strategy of focusing scarce resources on big cases.

So let me make sure I can crystallize this: On the one hand, the FDA is doing the job it is required to do by statute when it approves New Drug Applications - applications that total say more two million pages for Ketek - and has plenty of intermediate investigations to address post approval drug safety problems, thereby allowing pre-emption to block the courthouse doors for people claiming a drug-related injury, but on the other hand, it does not have enough financial resources to investigate reported instances of alleged drug company wrongdoing. Waxman's report noted 138 cases in which headquarters did not take enforcement actions recommended by inspectors.

In the rarefied air of marble and granite courthouses where conservative judges cite scholarly articles to support tossing real life claims of unsafe drugs based on the FDA position, how will actual day to day facts affect the FDA's position on Preemption? Maybe the agency can take its scarce resources and check out alleged wrongdoers rather than spend time and money filing briefs in pending cases? Would that be a good start?