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FEDERAL FDA PREEMPTION LEGISLATION

August 7th, 2007 by Dawn Mefford

The issue of federal FDA preemption, the beloved safety net for pharmaceutical companies, has once again reared its ugly head as the Senate and House attempt to reconcile their differences in re-authorization bills for the Prescription Drug User Fee Act (FDUFA).  In a product liability suit relating to insufficient warnings for prescription drugs, a pharmaceutical manufacturer will often argue that by meeting FDA labeling requirements, any suit alleging that the warning is insufficient is statutorily preempted by the FDA approval of such warnings.  With the legislative attempts to re-authorize the FDUFA, the Senate and House have currently standing bills which contain subtle differences in regards to this important issue. 

Although neither chamber’s version contains explicit preemption language, the Senate’s version, 1082, is the preferred version for pharmaceutical companies.  In particular, the Senate version deposits greater control in the hands of the FDA by requiring that the FDA approve all labeling changes through a newly accelerated process.  By placing more authority with the FDA, the pharmaceutical industry is hoping that responsibility for updating and changing warnings will shift from themselves to the FDA, thereby eliminating liability in situations where the FDA reviews and approves label warnings.
 House bill 2900 at one point contained explicit anti-preemption language.  Although this explicit language has since been omitted, both consumer groups and the plaintiffs’ bar have spoken in favor of this version.  House bill 2900 now states that it would have no effect on labeling changes which do not require FDA pre-approval.  Further, the bill does not alter a pharmaceutical manufacturer’s responsibility to maintain its own warnings and labels.

If and when the FDUFA differences are reconciled and it is re-authorized, there is little doubt that the issue of preemption will continue to be hotly debated and litigated.

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