FDA's request for comments on First Amendment issues creates a forum for stakeholders to submit comments on FDA's policy regarding off-label claims.

The ¹ May 16 Federal Register notice poses nine questions that are meant to facilitate discussion. Among them is one asking: "Would permitting speech by manufacturer, distributor, and marketer about off-label uses undermine the [FD&C] Act's requirement that new uses must be approved by the FDA?" and "What is the extent of FDA's ability to regulate speech concerning off-label uses?"

In the notice, FDA explains that the agency "wishes to learn what empirical evidence exists concerning the effect of commercial speech on the public health, and whether its regulations in this field in fact advance public health."

The agency seeks comments on the legal basis for its regulatory policies in light of recent First Amendment case law, which "has emphasized the need for not imposing unnecessary restrictions on speech," according to the notice.

A particularly salient case is the April 29 U.S. Supreme Court ruling on Thompson v. Western States Medical Center. The decision overturned FDA's restrictions on the advertising of compounded drugs, and states that the agency's interest in preserving the integrity of the new drug approval process could be advanced by means other than limiting commercial speech.

The notice makes the case that a more restrained approach to the regulation of commercial speech may be in order to preserve the agency's credibility, a position more in line with the philosophy promoted by FDA Chief Counsel Daniel Troy (² Also see "FDA Guidance Practices Are Good Model For HHS – General Counsel Azar" - Medtech Insight, 29 April, 2002., p. 11).

The agency will have to strike a delicate balance in attempting to reconcile its public health mission with judicial trends that suggest regulatory restraint in dealing with commercial speech, the Federal Register notice suggests. "There may be tension between some aspects of FDA's authority and judicial developments," FDA acknowledges.

The notice emphasizes that the agency is not announcing a wholesale policy change. "To be sure, FDA will continue to regulate commercial speech as part of its mandate."

Nevertheless, the boundaries of FDA policies presumably could shift somewhat on certain issues, depending upon the strength of the legal arguments submitted.

The issue of off-label use, for example, was left largely unresolved in the wake of the Washington Legal Foundation v. Henney ruling (³ Also see "Lawyers Struggle To Clarify "Muddy Waters" In Wake OF WLF Decision" - Medtech Insight, 6 March, 2000., p. 19).

Troy, in particular, is very familiar with that issue. Before he joined the agency, Troy was one of the attorneys for the Washington Legal Foundation during its challenge of FDA's regulation of off-label journal reprint dissemination.

Since the WLF case, FDA has avoided a clear declaration of limits on off-label promotion, which some feel has increased confusion about where the boundaries lie (⁴ Also see "Internet Device Promotion Policies Still Evolving, PAPS Staffer Wolf Tells FDLI" - Medtech Insight, 22 October, 2001., p. 10).

Earlier this year, FDA issued a notice affirming its off-label dissemination policy, saying that distribution of off-label journal reprints alone is "unlikely" to trigger enforcement action against a manufacturer (⁵ Also see "FDA Denies WLF Petition To Allow Dissemination Of Off-Label Information" - Medtech Insight, 4 February, 2002., p. 5).

The May notice, however, indicates that the agency could be reopening the issue. WLF said that it plans to submit comments to FDA on the topic. The group expressed concern that the way in which the request was written might suggest that FDA believes truthful information could be suppressed if it could negatively affect the public health.

The notice requests initial comments by July 30. Reactions to those responses must be submitted to the agency by Sept. 13.

The request for comments on First Amendment issues follows an early pattern of the approach to legal trends during the Troy era at FDA. The FDA attorney previously convened a "moot court" to hear arguments on Waxman/Hatch issues, with the goal of having both sides explain the legal underpinnings of their positions so that FDA would be on more certain footing for future decisions.

One potential benefit of that approach is that it forces interested parties to state a position publicly and in the relatively dispassionate format of a legal brief, which in turn can make it easier for FDA to identify the areas of genuine disagreement.

FDA Opens Floor For Debate Of Off-Label Claims, First Amendment Issues

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