Court Says FDA Can’t Restrict Off-Label Drug Use Materials

WASHINGTON—A federal judge has declared unconstitutional several sections of the Food and Drug Administration Modernization Act (FDAMA) that regulate the ability of pharmaceutical companies to distribute to physicians certain materials regarding off-label uses of drugs.

The decision, by Judge Royce C. Lamberth of the US District Court for the District of Columbia, follows a similar ruling last year that overturned then-existing FDA rules. FDA had argued that provisions in FDAMA superseded the regulations previously ruled unconstitutional and that the new regulations fell within constitutional limits. The judge resoundingly rejected this argument.

The Court’s Order

In his decision, Judge Royce C. Lamberth enjoined the FDA from prohibiting, restricting, sanctioning, or seeking to limit any maker of drugs or medical devices, or any person, from:

Distributing to physicians or other medical professionals “any article concerning prescription drugs or medical devices previously published in a bona fide peer-reviewed professional journal, regardless of whether such article includes a significant or exclusive focus on unapproved uses for drugs or medical devices that are approved by FDA for other uses and regardless of whether such article reports the original study on which FDA approval of the drug or device in question was based.”

Providing “any reference textbook (including any medical textbook or compendium) or any portion thereof published by a bona fide independent publisher and otherwise generally available for sale in bookstores or other distribution channels . . . regardless of whether such reference textbook or portion thereof includes a significant or exclusive focus on unapproved uses of drugs . . .”

“Suggesting content or speakers to an independent program provider in connection with a continuing medical education seminar program or other symposium, regardless of whether unapproved uses for drugs or medical devices that are approved by FDA for other uses are to be discussed.”

A copy of the court injunction was published in the Aug. 12, 1999, issue of the Federal Register.

“FDAMA largely perpetuates the policies held unconstitutional by the court on July 30, 1998, and therefore may not be applied or enforced by FDA,” Judge Lamberth wrote in his 16-page decision. “The principal issue in this case has always been whether the FDA has unconstitutionally burdened plaintiff’s First Amendment rights.”

The FDA was given 60 days in which to appeal the judge’s decision, and the agency is expected to do so.

The ruling is the latest in a legal action that was initially filed in 1994 by the Washington Legal Foundation (WLF), a public interest law and policy center devoted to “relieving consumers and free enterprise from undue interference from government regulations.”

At issue in the case were FDA regulations that prohibit pharmaceutical companies from providing to physicians published, peer-reviewed scientific papers and book sections that discuss the off-label uses of drugs. Glenn G. Lammi, chief counsel of WLF’s Legal Studies Division, said that the court’s decision “will benefit patients and doctors while sending a signal to government in general that censorship is not an acceptable substitute for regulating behavior.”

The FDA contended that the FDAMA rules in question did not violate the First Amendment’s protection of commercial speech because the law “affirmatively permits speech so long as it complies with the requirements of the statute,” a concept that Judge Lamberth ridiculed. “This is, of course, preposterous,” he said. “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 restated the finding in his 1998 decision that the scientific materials at issue were not false, misleading, or, as the FDA contended, “inherently misleading.” He rejected the government’s argument that valid scientific publications would be misleading because drug companies have an incentive to provide physicians only materials that show their products in a favorable light and to omit negative publications.

The judge found that argument wanting because “‘potentially misleading’ speech is not proscribed under the First Amendment” and because the FDA took a different view toward the same materials when they were disseminated under other circumstances. For example, Judge Lamberth noted, the FDA had “no concern over the exchange of article reprints and reference texts among physicians; more telling, defendants [the FDA] do not even object to a manufacturer providing such information to a health care provider upon such person’s request.”

The judge did uphold the government’s contention that the FDA has a public interest in encouraging drug companies to seek approval for off-label uses of their products. He ruled that a drug company may distribute information on off-label uses only if it has complied with one of three requirements:

It has submitted a supplemental application for approval of the off-label use.

It has certified to the FDA that such supplemental application will be forthcoming as provided in the statute.

The Secretary of Health and Human Services has determined that the manufacturer is exempt from this requirement because the supplemental application would be economically prohibitive or would require unethical studies.

At a WLF press briefing on the decision, attorney Daniel E. Troy of Wiley, Rein & Fielding, who served as WLF’s co-counsel in the case, predicted that Judge Lamberth’s ruling would be upheld, if appealed. He noted that during the 1990s, the Supreme Court has extended the First Amendment protection of commercial speech.

“Given the Supreme Court precedence on this issue, we certainly expect the courts will continue to protect the dissemination of independently generated, truthful, peer-reviewed scientific information about life-saving uses of drugs,” Mr. Troy said.