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Wednesday, November 12, 2008

Corporate Argument Against Preemption?

Our friends over at the PopTort Blog sent us a rather interesting article from Forbes recently. One might assume that with their rather large corporate constituency, Forbes would be supportive of efforts by the Food and Drug Administration and the Chamber of Commerce to push preemption of state jury verdicts that hold corporations accountable and establish stronger consumer protections. Interestingly enough, however, the magazine argues that giving full regulatory authority to the FDA could hurt not only consumers, but drug companies as well.

Reporter Matthew Harper argues in his piece “Could Preemption Hurt Drug Companies?” that increased criticism of the FDA, particularly following its seemingly premature approval of drugs like Vioxx and Avandia, has already made agency officials overly wary when considering new drugs. While this may sound like good news (we would all hope that the FDA is vigilant in its approval of new drugs), at least in Mr. Harper’s view, this overly cautious approach makes the regulatory processes facing drug manufacturers more daunting - chilling efforts to formulate new and important medicines.

Mr. Harper goes on to state that if the already besieged FDA were to be faced with the sole responsibility of ensuring the safety of all drugs, with no responsibility shouldered by the pharmaceutical companies, this chilling effect would only worsen. “Getting rid of drug lawsuits could make the FDA more vulnerable to political pressure -- because politicians could emphasize that the agency had been given the absolute last word on a drug's safety.”

According to this argument, “the immediate threat to the drug industry’s survival isn’t lawsuits, which pharma has shown it can beat. It’s the fact that safety controversies have demoralized the FDA, made it defensive and made it impossible to get new drugs approved. If the preemption could increase the pressure on the FDA, which at least seems plausible, drug companies would actually be better off without it.”

While we wouldn't necessarily agree that the FDA is currently too cautious in approving new treatments and drugs, we certainly agree that responsibility for their safety should be shared. The FDA lacks both adequate funding and staff resources to take on this Herculean task alone. Any attempts to make this argument digestible by corporate types, is certainly helpful. Despite what the Chamber of Commerce and its warriors for tort reform claim, state tort law has always served to complement government regulation. To do away with this long-established principle without explicit Congressional approval would be hugely irresponsible.

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