US FDA Draft Rules "Should Be Challenged In Court"

The lawsuit brought by the Washington Legal Foundation against the US Food and Drug Administration's draft policy on promotion on unapproved uses of approved drugs and devices and industry-sponsored scientific and educational activities (Marketletter February 27), is to proceed in court, a DC federal court judge has ruled this month.

Judge Royce Lamberth rejected the FDA's motion to have the suit dismissed on the grounds that the draft policy, which dates from November 1992, is not a completed regulation, and that it only addresses activities by manufacturers. While the policy is still only a draft, it has had the regulatory effect of a final rule and can therefore be challenged in court, he said. "The collective effect of the FDA's conduct has been to discourage manufacturers from disseminating information that they would otherwise have chosen to distribute," he said, and thus the impact of the effect on free speech could be challenged.

Without Challenge, "FDA Could Make Its Own Rules" Unless proposed rules such as this, which take a very long time to become final, are challenged in court, the FDA would effectively be able to regulate the industry through the rules without ever exposing them to judicial review, said Judge Lamberth. If the courts were not permitted to challenge the effects of a rule until the agency had declared it final, he said, the FDA would in effect be able to make its own rules. It could achieve this "through the simple expedient" of first, never formally declaring a policy to be final, and second, by "threatening, but never actually initiating enforcement procedures against companies which failed to comply with the agency's de facto policy."