FDA Appeals Court Ruling About Off-Label Drug Materials

WASHINGTON—A federal appeals court has granted expeditious status to an appeal seeking to overturn a US District Court decision that found parts of the Food and Drug Administration Modernization Act (FDAMA) unconstitutional. The district court ruling restricted the FDA’s powers to regulate the distribution by pharmaceutical companies to physicians of materials regarding off-label uses of drugs. [See Oncology News International, Oct. 1999, page 1.] The US Court of Appeals for the District of Columbia will hear oral arguments in the case on Jan. 4, 2000.

“We said all along that we were disappointed by the ruling and wanted to keep our options open, and we have decided to appeal,” said FDA spokesman Brad Stone.

Last July, Judge Royce C. Lamberth, of the US District Court for the District of Columbia, ruled that the FDAMA provisions were a violation of free speech. He barred the FDA from enforcing certain restrictions that prohibited drug companies from providing physicians published, peer-reviewed scientific papers and book sections that discuss the off-label uses of drugs.

Judge Lamberth’s July ruling followed a similar one by the jurist in 1998 that overturned then-existing FDA rules. The agency then argued that provisions in FDAMA superseded those ruled unconstitutional by the district court, an argument the jurist did not accept.

“The First Amendment is premised upon the idea that the people do not need the government’s permission to engage in truthful, nonmisleading speech about lawful activity,” Judge Lamberth wrote in his latest decision.