On January 28, 2002 the FDA rejected a Washington Legal Foundation (WLF) petition filed on May 29,2001 and supporting comments filed by the Coalition for Healthcare Communication on November 13, 2001. These filings challenged current FDA interpretation of court rulings as set forth in the March 16, 2000 Federal Register concerning the dissemination by pharmaceutical manufacturers of peer review journal articles and textbooks as well as support of Continuing Medical Education(CME) programs that contained off-label information . The filings were the latest salvo in the battle over First Amendment rights of both pharmaceutical manufacturers and physicians.

While rejecting the objections made by WLF and the Coalition, the FDA acknowledged the need for its enforcement personnel to be respectful of First Amendment rights. In addition FDA indicated that it was "unlikely to initiate an enforcement action where the only evidence of an unapproved intended use is the distribution of enduring materials or sponsorship of CME." It was the Coalition's position that FDA would run afoul of the First Amendment should they try to act against mere dissemination or sponsorship of CME.

While the Coalition disagrees with the FDA position, it is clear that the FDA has become extremely sensitive to potential First Amendment conflicts with governmental enforcement efforts involving marketing and promotional activities. The Coalition intends to remain vigilant in scrutinizing FDA enforcement activities to ensure that they do not impede the dissemination of important and truthful health care information.