Washington Legal Foundation v. Henney
(202 F. 2d 331, US Ct. Appeals, DC cir. Feb 11, 2000)

Briefed by: Anna Longwell, Esq., April 2000

Summary

This was a case in which a lower court had found that FDA regulations pertaining to some kinds of information dissemination, and the provisions of FDAMA relating to the same activity, were unconstitutional. The DC judge issued an injunction. “defendants shall not in any way prohibit …(pharma or device) manufacturers” from distributing specific types of literature, or conducting certain types of medical education classes, describing unapproved uses for medical products. Appeals Court dismisses FDAs appeal, but vacates the lower courts injunction, on the basis that FDA now admits it cannot prohibit such activity, but only that it can use such activity as evidence of intended use.

History

WLF, a non-profit organization, challenged FDA’s policies restricting the dissemination by manufacturer’s of medical textbooks and peer-reviewed articles, as well as manufacturer-sponsored CME describing uses for products that were not approved by FDA. By the time the case came to court, the guidances had become regulations, and by the time the case was decided, FDAMA, with other but similar restrictions, had been passed. The types of guidance at issue were 1) continuing Medical Education (CME) guidance detailing what the relationship between the provider and the sponsor could be in order for FDA to find the activity unobjectionable, 2) published paper guidance, which required that the principal topic of literature distributed by the firm must be the indication or use approved by FDA, and 3) medical book guidance, which required that the book not be edited or published by the manufacturer. The lower court performed a First Amendment analysis of the information dissemination activities and found that the activity was commercial speech and hence protected under the First Amendment. The lower court found that e this set of restrictions on commercial speech failed one of the tests for restrictions on commercial speech (e.g., it was more restrictive than it need to be to accomplish its intended purpose, which was encouraging sponsors to file their new uses with FDA). Therefore, the court issued an injunction prohibiting FDA from issuing regulations or guidances prohibiting such activity. In the meantime, FDAMA had become effective, with some provisions (21 USC 360aaa, et. seq.) which set conditions on the dissemination of material or the conduct of CME sessions were included. At the request of both parties, the lower court reviewed these provisions and also found them unconstitutional for the same reason. FDA appealed. During the appeal, FDA agreed that it did not have the right to restrict speech in this manner. FDA asserted it now interpreted both the law and the regulations to describe conditions of information dissemination that would preclude FDA from considering the dissemination evidence of a new intended use. (essentially, a “safe harbor”).

Findings

  1. The Appeals court did not address the basic First Amendment argument, however it appeared to concur with it.
    The court, in a footnote, says “we do not criticize the reasoning or conclusions of the district court”. But it refused to rule on an issue that had now become hypothetical, since FDA insists that “nothing in the provisions challenged in this case provide the FDA with independent authority to regulate manufacturer speech”, nor was it claiming such authority..
  2. The appeals court vacated the lower court’s decisions and injunctions insofar as they declare FDAMA. And the CME guidance unconstitutional
    In a footnote, the Court states that “part of its (lower court) injunction still stands”. Presumably, this is the part of the injunction that prohibits any regulation restricting manufacturer speech. However, as long as FDAMA is interpreted to provide, not an absolute restriction, but a description of a safe harbor, and regulations are crafted with this interpretation in mind, there is no constitutional question.

 

Results

FDA has interpreted 21 USC 360aaa, et.seq., to be a “safe harbor” description, not a speech restriction. The court has deferred to this interpretation.

Conclusions

Don’t disseminate literature on off-label use unless you are prepared to be a test case.