US Court of Appeals endorses FDA pre-emption

In what the Legal Intelligencer has termed "a big win for drug manufacturers," the 3rd US Circuit Court of Appeals for the Western District of Pennsylvania has upheld the US Food and Drug Administration's pre-emption of state law on the issue of prescription drug advertising. The decision means that the pharmaceutical industry faces more certainty in the regulatory sphere and fewer avenues for litigation.

In a 51-page opinion, Judge Brooks Smith stated: "to allow generalized state consumer fraud laws to dictate the parameters of false and misleading advertising in the prescription drug context would pose an undue obstacle to both Congress' and the FDA's objectives in protecting the nation's prescription drug users."

A dissenting judge argued that, because the federal agency nether has the power to require the pre-approval of advertisements nor, allegedly, the resources to enforce standards, the pre-emption argument should not be accepted.