June 4, 2012 – In recent comments to the FDA regarding a draft guidance that would call for prior review of six categories of direct-to-consumer (DTC) television ads, the Pharmaceutical Research and Manufacturers of America (PhRMA) stated that it is “concerned” that the FDA’s proposal infringes on the drug industry’s First Amendment rights.

Coalition for Healthcare Communication Executive John Kamp predicted back in April that a First Amendment challenge to the draft guidance – which describes the full array of DTC TV ads the FDA intends to make subject to a pre-dissemination ad review provision mandated by the Food and Drug Administration Amendments Act of 2007

– was possible. See http://www.cohealthcom.org/2012/04/09/fda-draft-guidance-on-dtc-tv-ads-raises-important-questions/

“I suspect the draft guidance will spark some interesting comments,” Kamp said in an April 9 column on the Coalition Web site. “Indeed, the guidance may be challenged under a provision in the FDA statute limiting pre-reviews, or perhaps even more dramatically as a violation of the ‘prior restraint’ limit on speech under the First Amendment.”

According to PhRMA, the draft guidance is, “in important respects, overbroad, unduly burdensome and lacking in narrow, objective, and definitive standards” and should be withdrawn, with any new proposal implemented “by means of notice and comment rulemaking in a tailored, risk-based approach that conforms with the Supreme Court’s directive [in Central Hudson] that ‘the First Amendment mandates that speech restrictions be narrowly drawn.’”

To support its position that pharmaceutical marketing is a form of speech protected by the First Amendment, PhRMA cites the June 2011 U.S. Supreme Court decision in Sorrell v. IMS Health and states that “DTC promotion – like other forms of advertising and promotion – is commercial speech that is protected by the First Amendment.” Later in the comment, PhRMA states that it is “concerned that FDA’s proposed pre-dissemination review of DTC television advertisements raises significant First Amendment concerns.”

PhRMA and industry commenters on the draft guidance also take issue with the FDA’s proposal that companies submit final recorded versions of TV ads before they are disseminated. “The requirement to submit a final recorded version of a TV advertisement will place a substantial financial burden on submitting companies,” because any FDA comments could force a company to “rework material that has already been fully produced at a significant cost,” PhRMA’s comment states.

This sentiment is echoed in other comments which assert that annotated storyboards of proposed TV ads should suffice for pre-dissemination review.

“The costs of submitting final broadcast ads and then re-shooting them because the FDA takes issue with a few aspects of the ads would most certainly be prohibitive,” Kamp said. “If this provision remains, it would be a huge blow both to industry and to the consumers who seek information about promising treatments.”

The comment period on the draft guidance closed May 14. “FDA’s next steps should be very interesting,” Kamp noted.