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Alex Sugerman-Brozan

House Subcommittee Caves In to Big Pharma on FDA Preemption provision

Cross-posted from Prescription Access Litigation (PAL) Project Blog

FDANews Drug Daily Bulletin reported today:

The House Subcommittee on Health passed legislation renewing the Prescription Drug User Fee Act (PDUFA) and other provisions with few amendments after staff meetings resolved concerns including language eliminating the FDA’s preemption authority. The bill now goes to the House Committee on Energy and Commerce for a markup June 21.

That language would have said:

“Nothing in this act or the amendments made by this act may be construed as having any legal effect on any cause of action for damages under the law of any state (including statutes, regulations, and common law.”

It would have clarified that the FDA’s approval of a drug does not preempt a lawsuit brought under state law alleging that a drug company injured a patient who took a drug, or failed to warn them about risks of the drug. This would reverse the FDA’s attempt to establish that its authority preempts such claims, which we addressed earlier this week in this blog (“‘The Hill’ gets it (partially) wrong on FDA & Preemption”). Henry Greenspan addressed this further in an excellent post over at TortDeform.com (“Preempting Preemption: Will Congress have the will to state its will?”)

The FDA and industry had taken great pains to characterize this provision as a change in the law, rather than what it was, a restatement and reestablishment of long-standing practice regarding the FDA and preemption: that state law claims are NOT preempted by the FDA’s approval of a drug (except in Michigan, which has the most draconian law in the country on this subject, denying even the most grievously injured patients the right to sue drug makers).

With the House version of the bill going before the full Energy and Commerce Committee now mirroring the Senate bill in saying nothing on this, the issue seems to be a dead letter.

I predict that before the ink is dry on this bill we will see drug companies arguing in such lawsuits that the Subcommittee’s removal of this language somehow demonstrates Congress’s intent to have the FDA preempt all state law claims on personal injury and failure to warn. Legislative intent, like beauty, is so often in the eye of the beholder. Can we say that a Subcommittee’s removal of a proposed particular clarifying provision means that the entire Congress intended that its passage of a bill express the exact OPPOSITE? (I.e. “since the bill didn’t say that the FDA doesn’t have preemptive authority, then the FDA does have such authority”) That seems like one heck of a stretch, but stay tuned — it will soon be appearing in a Motion to Dismiss near you.

Alex Sugerman-Brozan: Author Bio | Other Posts
Posted at 12:17 PM, Jun 21, 2007 in FDA | Federal Preemption | Legislation | Preemption
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Comments

The dreaded negative inference will raise its head. Actually, it's not the argument that's annoying -- it's the fact that any number of Republican judges will leap at the opportunity to embrace it.

Posted by: dp | June 22, 2007 2:45 AM