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Taking on big pharma - and the FDA: the fight against federal preemption is far from over, but some courts have rejected drug company claims that an FDA preamble should be granted sweeping deference.

Article Excerpt
Our American system of drug regulation is heavily frontloaded. The FDA spends a lot of time and energy (though not always enough) evaluating a proposed drug's safety and efficacy before approving it. But this initial evaluation is inherently constrained by the limited data available from clinical trials conducted before the product enters the marketplace. Ultimately, the FDA makes a judgment based on the limited data available about whether a drug should be approved.

Once a drug receives its initial approval, however, the FDA backs way off. In most cases, the agency does not initiate postmarketing reviews of a drug's safety. Instead, the FDA leaves it to the drug manufacturers to alert it when actual use of a product reveals greater hazards. And postapproval enforcement has declined precipitously under the current administration.

Under these circumstances, you might imagine that the FDA would welcome state tort law as a complementary set of protections for consumers of drug products. Indeed, the chief counsel of the agency during the Clinton administration once wrote: "FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection." (2)

But under the Bush administration, all that has changed. The FDA has thrown its considerable administrative weight behind a dangerous argument that drug companies are advancing to get out from under state tort liability. The companies argue that state products liability claims--especially claims for failure to warn about a drug's risks--are preempted by federal laws and regulations. And the Bush FDA is backing them up.

Fortunately, these efforts are facing resistance from the plaintiff bar and advocates for drug consumers. The battle is far from over, but several recent decisions suggest that the law may be heading in the right direction.

A little history

For decades, state products liability law and federal regulation of drugs have happily coexisted. State tort actions against drug companies have been recognized for well over a century. When Congress enacted the Food, Drug, and Cosmetic Act (FDCA) in 1934, it decided not to include a private right of action for damages on the ground that it was "unnecessary," because a "common law right of action exists." (3)

In recent decades, the FDA repeatedly acknowledged that there was no conflict between these two systems for consumer protection. In the 1979 preamble to an FDA labeling regulation, for example, the agency expressly acknowledged that "it is not the intent of the FDA to influence the civil tort liability of the manufacturer." (4)

Similarly, two decades later, when the agency issued a regulation concerning medication guides for prescription drugs, the FDA rejected a drug company suggestion that it preempt "state regulation with respect to civil tort liability claims and other labeling requirements." To the contrary, the FDA said it "does not believe that the evolution of state tort law will cause the development of standards that would be at odds with the agency's regulations." (5)

Drug companies periodically argued in court that some plaintiffs' claims against them were preempted by federal...

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