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Re: Judge Fallon’s opinion, Congress had a chance to speak on preemption as part of the FDARA legislation. There was such a clause in the House version. But it was removed after very heavy objections from preemption’s defenders.

Sorry to repeat myself, but the “fraud exception” is, in practice, meaningless. The only way one would know if “a company knowingly hid or falsified info that would have led the FDA to make a different decision about approving a drug” would be if, once the info had been discovered, the drug was, in fact, withdrawn. There are many other possibilities - label change, fine plus some kind of remedial action required, and so on.

Further, “knowingly” hiding and falsifying info from the FDA is felony fraud, which would have to be proven in court. As the law now stands, only the FDA can bring action against a company for intentionally defrauding the agency. As written in an earlier comment, in the context of pharma, that has happened 0 (zero ) times in the past 25 years. FDA/Justice has brought misdemeanor charges instead, even in egregious and clear cases, rather than making the effort to prove intent.

We know this well in Michigan because we have lived under an FDA preemption statute, with such a “fraud exception,” for eleven years.

Good question. I was referring to prescription drugs, specifically. From what I gather there’s a preemption clause in the Medical Device Act, but no language like it in the Food and Drug act. Fallon refers to the FDA’s regulatory “preamble.”

Of course, the Supremes may well decide something in the Medtronic case that affects pharma, but who knows?

Thanks for taking the time to write in,

ed s
pharmalot editor