Judge rules FDA cannot impede literature about off-label uses

Companies can freely distribute peer review articles that discuss off-label uses.

Issue: September 15, 1999

[Sidebar: FDA issues final guidance for direct-to-consumer ads]

WASHINGTON — A court ruled July 28 that the Food and Drug Administration (FDA) cannot stop drug and device manufacturers from distributing copies of peer reviewed articles and textbooks about off-label uses of their approved products.

The court’s final decision limited the FDA’s regulation of reprinting and distributing peer review articles or textbooks that discuss off-label uses. The court upheld the right to redistribute peer-reviewed articles and textbooks not on arcane points of law, but on the most basic American right — free speech.

The U.S. District Court for the District of Columbia issued its final decision in a suit filed by a private advocacy group that had railed against the FDA’s policy of restricting when and how drug and device makers gave out reprints of articles and books that addressed off-label uses.

The Washington Legal Foundation filed its first case against the FDA in 1994, and the July 28 decision is the final ruling needed at the district court level.

Richard Samp, JD, chief counsel for the Washington Legal Foundation, said, “This is the death knell to FDA’s claims that it is not subject to the First Amendment. Throughout our litigation, FDA essentially said that the First Amendment does not apply. I just don’t believe that they will be able to make that argument any more.”

According to Mr. Samp, the ruling does not give manufacturers free rein. They cannot lie about their products, advertise any way they want, or put any claim desired within their labels. The injunction is limited to peer reviewed journal articles and medical textbooks.

“As long as materials meet the criteria that the judge has established, then manufacturers are free to act without having to give any submissions to FDA in advance to distribute them,” Mr. Samp said.

Strong, stern decision

The ruling leaves the FDA in the position of deciding what to do next. According to spokesman Brad Stone, FDA staff is talking with the Department of Justice about whether to appeal and what strategies exist.

“The FDA Modernization Act set forth a balance between, on the one hand, providing physicians with potentially useful information about the off-label uses of products and, on the other, ensuring that there was going to be balance in those presentations and an incentive to develop more information about those potential uses,” he said.

The FDA passed a final rule in the Federal Register on Nov. 20, which implemented the FDA Modernization Act provision, that required that drug and device makers who hand out articles about off-label uses present balanced information — as determined by the agency — and seek agency approval for the use.

The court struck down the stabilizing provision and FDA’s rules in a strong, stern decision. It prohibits the agency from restricting drug and device makers from distributing peer reviewed articles or books about off-label uses, or from suggesting content or speakers to an independent program.

The agency has only one power left, Mr. Samp said. It can require drug or device makers that sponsor article distribution to disclose interest in the product and that the product has not been approved by the FDA.

Free speech at stake

In the decision, district court Judge Royce C. Lamberth wrote that, “The principal issue in this case has always been whether the FDA has unconstitutionally burdened plaintiff’s’ First Amendment rights.”

According to the decision, the FDA had argued that free speech rights did not apply because the act “affirmatively permits” speech that complied with its provisions of balance and disclosure.

The judge wrote, “This is, of course, preposterous. The First Amendment is premised upon the idea that people do not need the government’s permission to engage in truthful, nonmisleading speech about lawful activity.”

The FDA argued that drug and device makers could present one-sided, positive articles that would be misleading.

The judge responded, “The government, however benign its motivations, simply cannot justify a restriction of truthful nonmisleading speech on the paternalistic assumption that such restriction is necessary to protect the listener from ignorantly or inadvertently misusing the information.”

He continued, “This axiom is particularly powerful where the recipient of information is a sophisticated listener trained extensively in the use of such information — as are the doctors and other health care providers in this case.”

He added that the FDA admitted the importance of peer review articles, that the FDA cannot restrict articles it perceives may mislead, and that the agency only objects to articles when the drug or device makers initiate the distribution, instead of when a physician requests the article.

“Constitutional blackmail”

The FDA Modernization Act and FDA’s regulation had required drug and device makers who handed out copies of peer review articles to submit an approval application to the agency within 3 years.

The judge did not dispute the FDA’s interests in wanting drug and device makers to submit their products for approval of supplemental uses. The way the agency went about that goal took a beating, however.

“The supplemental application requirement of the act amounts to a kind of constitutional blackmail — comply with the statute or sacrifice your First Amendment rights. It should go without saying that this tactic cannot survive judicial scrutiny.”

The court pointed out the FDA did not ban off-label uses, did not try to fine those who did not seek approval, nor did it tighten enforcement of misbranding. Instead, the agency put conditions on Constitutional rights after a supplemental drug application was submitted.

“The supplemental application requirement burdens substantially more speech than necessary to advance the government’s legitimate interest, and it therefore violates the First Amendment.”

For Your Information:

Richard Samp, JD, is chief counsel for the Washington Legal Foundation. He can be reached at 2009 Massachusetts Ave. NW, Washington, DC 20036; (202) 588-0303; fax: (202) 588-0386. Mr. Samp has no direct financial interest in any of the products mentioned in this article, nor is he a paid consultant for any companies mentioned.

Brad Stone is a spokesman for the Food and Drug Administration. He can be reached at (HFI-2) 5600 Fishers Lane, Rockville, MD 20857; (301) 827-6250; fax: (301) 827-1219. Mr. Stone has no direct financial interest in any of the products mentioned in this article, nor is he a paid consultant for any companies mentioned.