Judge Strikes Down FDA Off-Label Rules

WASHINGTON--A federal judge has ruled that FDA regulations governing the dissemination of research data supporting the off-label uses of approved drugs and medical devices violate the First Amendment’s guarantee of freedom of speech.

US district judge Royce C. Lamberth invalidated three FDA policy documents regulating the distribution of reprints from scientific journals and medical texts. In his decision, the jurist noted that off-label use is common and that many physicians "consider off-label use to constitute the standard of good medical care" in some diseases.

The FDA, after reviewing the 58-page opinion and consulting with the Justice Department, filed a motion asking Judge Lamberth to clarify several points in his decision and to stay his order that the FDA publish the ruling in the Federal Register until the clarifications are made. Specifically, the agency asked whether the injunction applies only to the three FDA guidance documents at issue and only to unapproved uses of products that have been approved for other uses, or extends to unapproved products as well.

Judge Lamberth’s ruling did not directly address changes in FDA guidelines dictated by the FDA Modernization Act of 1997 because the law does not become effective until this fall. FDA is currently evaluating public comments on its proposed regulations to implement the Act.

First Amendment Expanded

The suit against the FDA was brought by the Washington Legal Foundation (WLF), which has pursued a number of legal actions against federal regulators on the grounds that their rules constitute undue interference in the affairs of individuals and businesses. In pressing its lawsuits, the foundation draws on a 1978 Supreme Court decision that made clear that "commercial speech" is also covered by the First Amendment.

Richard A. Samp, WLF’s chief counsel, said that "many federal agencies adopted rules limiting speech long before 1978, and it has taken many of them, FDA included, a number of years to realize the implications of the expansion of the First Amendment to cover commercial speech. The decision by Judge Lamberth, Mr. Samp said, "places FDA squarely under the limitations of the First Amendment. The FDA tried to argue that they weren’t limiting speech; all they were doing was limiting conduct. The court gave short shrift to that argument."

Judge Lamberth wrote: "In asserting that any and all claims about the safety, effectiveness, contraindications, side effects, and the like regarding prescription drugs are presumptively untruthful or misleading until FDA has had the opportunity to evaluate them, the FDA exaggerates its overall place in the universe."

In his opinion, the judge acknowledged a strong FDA interest in encouraging companies to seek supplemental approval for recognized off-label uses of their products and that the restrictions imposed by the FDA advance that goal. But in striking down the FDA regulations, Judge Lamberth ruled that the agency had restricted truthful speech more extensively than necessary. His decision, however, upheld the agency’s power to regulate and suppress false and misleading claims and to require that companies that do circulate information include a disclaimer making clear that the FDA has not approved the off-label use described.

Mr. Samp suggested that the court’s decision will not have a huge immediate impact. "What we asked for was fairly limited," he said. "We wanted to limit what was disseminated only to information that was indisputably true."

Three FDA Documents

Judge Lamberth’s ruling applies to three FDA documents: the Dec. 3, 1997 "Final Guidelines" on financial support provided by manufacturers for continuing medical education; the Oct. 8, 1996 "Guidance" covering dissemination of materials from medical texts; and the "Guidance" issued the same day covering distribution of journal reprints.

The FDA Modernization Act requires the FDA to redraw its regulations regarding the dissemination of information about off-label uses of medications and medical devices. The agency issued its proposed new rules in June.

With these rules, no longer would manufacturers have to wait until FDA approved their supplemental applications before they could provide "reliable and balanced" information to groups that include physicians, pharmacy benefit managers, insurers, and group health plans. But companies would have to certify they would file a supplemental application or receive an exemption on grounds that the needed studies were unethical or economically prohibitive.

The off-label information distributed would be only for drugs already approved; be an unabridged copy of a peer-reviewed article or reference publication; be neither false nor misleading; make certain disclosures, including the fact that FDA has not approved the off-label use, and provide the approved official labeling.

Judge Lamberth’s decision could force FDA to revise its proposed rules. If not, it is "conceivable" that the WLF will once again sue the agency, Mr. Samp said. The foundation strongly criticized provisions in the anticipated off-label regulations.

"We thought FDA was using its regulations to gut the Modernization Act," Mr. Samp said, citing the supplemental applications exemption provision. Under the Act, a company could still disseminate off-label information if it could show that seeking supplemental approval for an off-label use was not economically feasible, he said. "FDA has through its [proposed] regulations defined that exemption out of existence. They have made it clear that they will rarely if ever approve such an application."