Ruling: reps can discuss off-label uses

Some Food and Drug Administration restrictions on the dissemination of off-label drug and medical device information are unconstitutional, according to a federal court ruling in February.

Judge Royce C. Lamberth, who presided over U.S. District Court for the District of Columbia, ruled that a decision he rendered last July was correct when it stated that some FDA regulatory restrictions violate freedom of speech, which is protected by the First Amendment.

How the ruling will affect promotional guidances outlined in the Food and Drug Modernization Act remains to be decided.

However, when the FDA asked Judge Lamberth to state that his ruling would not invalidate the new law, which was enacted prior to last July's ruling, Lamberth replied: "Clearly, it was not the court's intention that implementation of the new legislation would render its decision moot."

The case at hand

Washington Legal Foundation filed the suit against the commissioner of the FDA and the secretary of the Department of Health and Human Services. Washington Legal Foundation is a non-profit public interest law and policy center whose mission is to defend "the rights of individuals and businesses to go about their affairs without undue influence from government regulators."

The foundation's legal team argued that physicians can legally prescribe an FDA-approved drug for any medical condition, regardless of the indication for which it was originally approved. Therefore, open dissemination of reliable clinical information about off-label treatments is legal and useful for physicians, regardless of who delivers the data.

The FDA and Department of Health and Human Services did not contest that off-label uses are legal but countered that "most physicians, well-educated and experienced though they may be, do not have the resources, experience or education to critically evaluate evidence concerning off-label uses. While physicians may believe that they are in a better position than the FDA to evaluate off-label claims, both the evidence and the law say otherwise."

Judge Lamberth reinforced three key points of his original ruling. They pertained to journal articles, reference textbooks and continuing education seminars.

Lamberth ruled that the FDA and Department of Health and Human Services should not prohibit, restrict, sanction or "otherwise seek to limit" pharmaceutical manufacturers or others from disseminating or redistributing articles concerning prescription drugs previously published in a bona fide peer-reviewed professional journal, regardless of whether the articles focus on drug uses not approved by the FDA.

The court defined a "bona fide peer-reviewed professional journal" as one that "uses experts to objectively review and select, reject or provide comments about proposed articles" and that those experts should have "demonstrated expertise in the subject of the article under review and be independent of the journal."

Lamberth ruled that the same rules applied to independently published textbooks and seminars. Neither the FDA nor the Department of Health and Human Services should prohibit or restrict pharmaceutical companies from "suggesting content or speakers to an independent program provider in connection with a continuing medical education seminar," regardless of whether the drug uses to be discussed were approved by the FDA or not.

Reactions to the ruling

Washington Legal Foundation was happy that it took on the case and won. "We are very pleased with the ruling," said Richard Samp, the foundation's lead counsel. "Essentially, Judge Lamberth agreed with us that the First Amendment protected those activities in the pharmaceutical industry and struck down these policies."

Anna Marie Kempic, lead counsel for the FDA, did not respond with comment.

Individual manufacturers may have been less likely to pursue this kind of lawsuit in the past because of the unique and complex role the FDA plays in pharmaceutical regulation and approval.

"We became involved in this lawsuit because the FDA seemed to be one agency that was particularly reluctant to recognize the First Amendment rights of those it was regulating," Samp said. "Pharmaceutical companies have been reluctant to pursue this issue because the FDA has regulatory authority, and it also has approval authority. Companies fear that if they develop the reputation of one who challenges FDA's regulatory authority, then they will be retaliated against when they try to have a new product approved." For this reason, Samp said, the Washington Legal Foundation felt it could play "a productive role in the debate."

The plaintiffs won't be resting on their laurel leaves for long, however. Lamberth directed both the defendants and WLF to file legal briefs addressing whether or not regulations issued by FDA pursuant to FDAMA are subject to the same ruling as those presented in Washington Legal Foundation vs. Freidman.

In the meantime, pharmaceutical companies are free to begin disseminating information about off-label uses that fits the criteria laid out by Lamberth.

"A manufacturer is not free to write up its own report about what it thinks are the good uses of its products off-label," Samp explained. "It can only send journal articles, and there haven't been a flood of such articles, because there is a finite number of journals that fit the criteria. But when it comes to these highly credible sources, the FDA has no right to restrict dissemination of the information." PR