Editorial: Paxil court order undercuts FDA

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One set of national rules for the advertising of nationally marketed products makes sense. It's a philosophy that's been regularly supported in this space but sometimes undermined elsewhere-by state and local governments, private litigants and sometimes even by marketers (who should know better). Last week, the battle was joined again when a U.S. district court judge in Los Angeles, ruling in a private lawsuit, ordered GlaxoSmithKline to halt current TV advertising for its Paxil anti-depressant drug by Sept. 1-even though the ads had previously won FDA approval.

In the wake of Judge Mariana Pfaelzer's move to ban the Paxil commercials, U.S. Justice Department lawyers quickly defended the "scientific and carefully considered view" of the FDA and said they would appeal (as did GlaxoSmithKline). They should do so, with ad-industry support if need be. Once federal trial judges in 50 states can set aside the FDA determinations, the idea of a national market for prescription drugs with one national regulator will soon be in tatters.

FDA ad decisions are not above ultimate review by the appeals courts. Nor should they be. The issue in this case-the adequacy of "warnings" in prescription drug ads-can be the focus of heated, and beneficial, debate. (In the Paxil case, the plaintiffs say they suffered difficult "withdrawal" symptoms when they stopped using the drug; the ad says Paxil is not habit-forming.) Someone has to decide such issues in a timely, consistent manner that protects drug users and drug makers. If FDA decisions offer no safe harbor, every drug ad claim would become fair game for litigants in courts around the country.

The ruling in this case is based at least in part on California law. If Judge Pfaelzer feels that law enables her to ultimately substitute her reading of the scientific evidence for that of the FDA, preserving the one-market/one-regulator idea for prescription ads is at risk.

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