FDA Slow to Tackle Free Speech Challenges

After months of anticipation, pharmaceutical marketers and the Washington legal community continue to wait for FDA to address options for updating its policies governing sponsor communications involving unapproved drug uses. FDA officials said more than a year ago that they would hold a public meeting to discuss agency policy related to industry “speech” on regulated products. That event now appears on hold until the agency issues further advisories on these issues. A draft guidance on communication of off-label information evidently is in development, a document that has become more critical – and more complicated – in the wake of court rulings challenging FDA restrictions on company communications as unconstitutional.

Additional guidance also is in the works to address the related issue of disseminating health care economic information, a key area of expanded communications sought by pharma companies. The 21^st Century Cures legislation approved by the House includes language authorizing greater flexibility for marketers to provide comparative effectiveness data to payers and formulary committees. FDA clarification of this issue is important, though, especially as prospects dim for fast Congressional action on this and related topics.

Pressure has mounted for FDA to address these concerns following rulings by the Supreme Court and other federal courts that support First Amendment protection for pharmaceutical marketers to present truthful and non-misleading information on approved therapies. In fact, the courts have indicated that a government agency needs highly compelling reasons to restrict commercial speech, and that more open discussion of treatment options involving biomedical therapies could be highly beneficial and save lives.

To avoid further legal confusion following the landmark Amarin v. FDA decision issued in August, standards are needed to clarify when marketing communication is truthful and non-misleading, commented attorney Douglas Hallward-Driemeier of Ropes & Gray at the recent advertising & promotion conference sponsored by the Food & Drug Law Institute (FDLI). Further discussion of FDA speech restrictions, he noted, should clarify what “substantial evidence” is needed to support promotional and comparative claims for drugs. These are “difficult, challenging and critically important questions” for FDA and industry to address, Hallward-Driemeier noted. But it is important to do so, he concluded, to avoid claims based on unreliable studies that could have “serious adverse health consequences,” while also ensuring the “free sharing of information” about pharmaceutical products.

Further delays in tackling these issues could mean that the courts take over this regulatory function, Hallward-Driemeier suggested. Soon after the Amarin ruling, Pacira Pharmaceuticals filed a suit challenging FDA efforts to block it from providing truthful information to doctors about using its anesthetic product Exparel for a broader range of surgical procedures than specified in its labeling. “It didn’t take long for the next shoe to drop after this summer’s dramatic Amarin decision,” said John Kamp, executive director of the Coalition for Healthcare Communication, referring to this latest legal action. At issue in this case is a warning letter sent Pacira by FDA’s Office of Prescription Drug Promotion (OPDP) instructing the company to halt such off-label marketing, and a favorable court ruling could further undermine OPDP enforcement authority.