FDA and Rep. Waxman Forget a Little Thing Called the First Amendment.

Late last week, a yet-to-be released FDA draft guidance on “Good Reprint Practices” was made public by Rep. Henry Waxman (D-CA). Waxman, on behalf of the Committee on Oversight and Government Reform, issued a letter to FDA strongly urging it to refrain from finalizing and disseminating this “ill-advised” guidance as it would “open the door to abusive marketing practices that will jeopardize safety, undermine public health, and lead to an increase in unapproved uses of powerful drugs.” A copy of Waxman’s letter and the FDA guidance can be found here.

Despite the hoopla over the Waxman letter, the guidance really does not represent any new general policy by FDA – it merely clarifies the types of reprints to be disseminated and how they should be disseminated.  The general principles of the guidance are consistent with FDA’s prior approach, as understood through the framework of FDA’s battles with Washington Legal Foundation (WLF):

the distribution of reprints is not an independent violation of law;

FDA has the authority to use reprints as evidence that a manufacturer has illegally promoted its product; and

FDA will not initiate an enforcement action where the only evidence of an unapproved intended use is the distribution of reprints.

Although the guidance does not represent any new general policy by FDA, its clarifications and the introduction of several new requirements for the dissemination of reprints make it a more restrictive approach.  The guidance clarifies that letters to the editor, abstracts, Phase I study reports, and reference publications that contain little to no discussion of investigations or data do not qualify as scientifically sound reprints.  (There is some debate among practitioners as to whether these types of publications are appropriate to disseminate.)  New and more restrictive requirements on how the reprint must be disseminated include the attachment of a comprehensive bibliography of publications discussing adequate and well-controlled clinical studies for the product’s use as disseminated in the reprint and the attachment of a representative article that calls into question the results published in the reprint.

The Waxman letter does not meaningfully acknowledge that the guidance does not represent a radical new approach by FDA.  Instead, the letter addresses the guidance as a departure from the more stringent requirements on reprint dissemination from the Safe Harbor provision of the FDA Modernization Act (which expired in September 2006).  Waxman fails to recognize, however, that although the Safe Harbor provision remained in effect after the WLF decision, FDA’s policy was not as restrictive after that decision and was largely the same as in the guidance.  Further, Waxman fails to address the fundamental decision of the WLF case – that manufacturers have a constitutional right to disseminate truthful, non-misleading reprints under the First Amendment

Much of Waxman’s letter cites to “abuses” of reprint distribution by the manufacturers of anti-depressants, Vioxx, Celebrex, Neurontin and antiarrhythmic drugs.  His letter to FDA includes a Committee Request for information on the development of the guidance and how FDA expects to enforce the principles outlined.  An FDA response is due by December 21, 2007.