More on the FDA controversy

26 Jul
2004

The sacking of Troy

Trial lawyers are hot about Mr. Troy because he aggressively pursues a settled legal doctrine: that federal law pre-empts state law with respect to what constitutes a safe and effective drug. Mr. Troy’s practice of filing amicus briefs in liability suits urging state courts not to second-guess the FDA-approved wording of warning labels is hurting lawyers’ ability to win scientifically dubious but highly lucrative verdicts.

As my Manhattan Institute colleague Walter Olson points out, the need for a federal agency to assert its authority is pretty clear: You can’t have individual juries defining for different reasons when a drug is or isn’t safe and effective. All of the living and former FDA general counsels, regardless of party, support Mr. Troy’s work and oppose the bill cutting his budget.

Their opinions were recently buttressed by a federal court decision upholding the legal basis for pre-emption. It agreed with the longstanding government position that the FDA’s decisions about what drugs are safe and effective were more scientific than any state court’s decision. The court also ruled that undermining pre-emption would harm public health by retarding research and development, would encourage “defensive labeling” by manufacturers to avoid state liability and would result in scientifically unsubstantiated warnings and underutilization of beneficial treatments.

This bill is part of a multi-front trial-lawyer war against the FDA. Trial lawyers are also attempting to force the release of unpublished safety and efficacy data so that private researchers can more effectively second-guess the agency. This also would let them use scientifically dubious information in their lawsuits.

The comments that kind readers posted yesterday are convincing me that this FDA policy has wisdom. I have major problems with pharmaceutical company marketing practices. I would disallow direct to consumer advertising. However, they should not have liability on safety issues if the FDA has reviewed the data. The trial lawyers want to sue using uninformed juries. Sophistry works well in the courtroom. It does not sway scientific panels.

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4 Responses to More on the FDA controversy

Avatar

arf

July 26th, 2004 at 12:26 pm

Maybe it’s ’cause its Monday and my brain ain’t in gear yet.

Federal law regarding safety of a drug trumps state rules.

How to reconcile that with the states that allow medical marijuana?

If the issue of medical marijuana becomes settled; that is, states can allow it even if the feds do not…..does that open up the floodgates to liability suits over more “conventional” prescription drugs?

Avatar

RGL

July 26th, 2004 at 10:26 pm

Like Dr. Centor, I would have deep misgivings about handing decisions about drugs approved by the FDA to uninformed juries. That is indeed what would open the floodgates to a flurry of lawsuits based on junk science generated by trial lawyers. It has happened in the past, and it is going to happen in the future if the Senate does not see see this anti-Troy bill differently.

The only ofshoot of this bill, if approved, would be more lawsuits and a new territory for trial lawyers to poach upon. They have made off with $14 billion in the tobacco lawsuit, carted off more billions with the never-ending asbestos saga, and currently are firing their initial shots at Mcdonalds and other fast-food outlets.

Is nothing safe anymore from the predatory instincts of the trial bar? It’s time to call a HALT!

Avatar

Bernie Simon

July 27th, 2004 at 9:12 pm

Sophistry works well in the courtroom. It does not sway scientific panels.

Have you ever been to a scientific conference? Hand waving arguments, extrapolation from small data sets, cherry picking observations? The only difference is that in a courtroom there’s someone to present the other side.

Avatar

Bernie Simon

July 27th, 2004 at 9:16 pm

OT link of the day:

Prince Charles praises Gerson therapy for cance. BMJ editorial blasts him for it and alt med supporters shoot back with both barrels.

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