Industry may rue its win against FDA

Medical Marketing and Media, Sep 1999 by Dickinson, James G

The First Amendment rules! After three years battling FDA encroachments on health product companies' free speech, the final victory that came in July in the Washington Legal Foundation's case against three FDA guidance documents surely seemed sweet indeed.

But it was almost immediately assailed by legal authorities as going too far. One even suggested that U.S. District Court Judge Royce G. Lamberth, a Reagan appointee who seems to delight in harassing the Clinton Administration whenever he can, could not have known how sweeping his latest, conclusory opinion in the case could be.

Former (Nixon era) FDA Chief Counsel Peter Barton Hutt, often regarded as the "dean" of Washington food and drug lawyers, said Lamberth's opinion -- which invalidated key sections of the recent FDA Modernization Act dealing with dissemination of off-label use information struck at half of everything the FDA does.

The FDA does only two things, Hutt said. It regulates substances and it regulates speech, chiefly in the form of product labeling but also advertising and promotion. Because of Lamberth's latest ruling, together with other recent negative court decisions on the FDAs First Amendment intrusions, the agency must now "reformulate" its entire approach to that second thing it does.

Other eminent FDA law experts agree with Hutt as to the huge impact Lamberth's ruling could have, but differ on how the agency should respond to the challenge. The bottom line in their assessments is that the FDA is greatly weakened in its authority to act on marketing activities. This is something industry may at first cheer but later come to have second thoughts about.

The essence of the new and evolving legal landscape for marketers is that, unless the FDA is able to restore its status quo on appeal (unlikely, given that the relevant appeals court has already just trounced the agency on similar First Amendment grounds in the Durk, Pearson dietary supplements labeling case), the FDA intervention in product marketing will likely become a public rarity.

But lest we get too far ahead of ourselves, let's first look briefly at the Lamberth decision itself.

He found (as he already had in July, 1998) that the FDAs three guidances on dissemination of reprints, textbooks, and continuing medical education (CME) materials and their underlying policies, rules, and regulations violated the First Amendment because they were more sweeping than the FDA's legitimate governmental interest required.

He also found that the FDA Modernization Act's sections controlling the dissemination of unapproved-use information and requiring the filing of supplemental new drug/device applications covering such uses also violated the First Amendment.

He enjoined the FDA from "in any way" seeking to limit anyone from disseminating to medical professionals any article about drugs or devices published in a bona fide peer-review professional journal "regardless of whether such article includes a significant or exclusive focus on unapproved uses ... and regardless of whether such article reports the original study on which the FDA approval ... was based." Lamberth extended this injunction to protect the dissemination of independently published textbooks and product manufacturers' suggestions of speakers and content to independent CME providers.

University of Florida law professor Lars Noah, a frequently published authority on FDA law, said Lamberth's ruling when taken in context with the Durk, Pearson case and others, means the FDA may have to abandon broad-based public rulemaking in labeling matters. Instead, he suggested, the FDA may have to rely on behind-the-scenes arm-twisting, and resort to precedent-setting, after-the-fact litigation in especially egregious cases of false and misleading statements.

"This is, of course, much less efficient," Noah acknowledged. "But it would also, perhaps, put the FDA in a better position to avoid these sort of First Amendment objections. They can still be raised in an enforcement context, but then you wouldn't have a judge looking at a broad, prophylactic rule that seems to be dealing with all sorts of truthful and non-misleading speech. Presumably, the agency will pick its targets carefully and have very good facts."

Noah predicted that a net result of this approach could be to make the FDA behave more like the National Labor Relations Board or the Federal Trade Commission, bargaining with individual entities, ruling more after-the-fact than it has customarily done in the past, and using less-formal methods of accomplishing its objectives. "The FDA might have to allow more questionable information out there than it is comfortable with," Noah said.

Former Chief Counsel Hutt's view of the new legal landscape is so serious for the agency that he believes the FDA should not appeal the Lamberth ruling. Given that the only court the agency can appeal to has already ruled so crushingly against it in the closely related Durk, Pearson case, the FDA "could get something ten times worse," Hutt said. The FDA's plight is given added emphasis by the recent decision of the Solicitor General not to allow the agency to appeal the Durk, Pearson decision to the Supreme Court. Hutt interprets that turndown as a clear signal that the Administration thinks the FDA cannot win.