Is FDA Guidance on Direct to Consumer Ads Unconstitutional?

Is FDA Guidance on Direct to Consumer Ads Unconstitutional?

May 25th, 2012 // 12:35 pm @


Two months ago, the FDA issued a draft guidance that stipulates when drugmakers must submit their direct-to-consumer TV ads for agency review. These include initial ads for any prescription drug, or for a new or expanded indication; all TV ads for drugs that are subject to a Risk Evaluation and Mitigation Strategy; all TV ads for Schedule II controlled substances, and the first TV ad following a safety labeling update or an enforcement letter, among other things (here is the draft guidance).

“These categories reflect a risk-based approach that will enable the Agency to leverage its limited resources to best protect the public health by ensuring that certain high risk and high impact TV ads accurately and effectively communicate key information about advertised products, including their major risks and indications,” the FDA wrote in its March draft guidance.

Drugmakers are not happy, though. Sanofi, for instance, complained to the FDA that submitting TV ads prior to airing could be very costly if the FDA requires revisions and, as a result, may prohibit DTC TV ads from running. Since then, the PhRMA trade group wrote a letter of its own to charge that a mandatory requirement that TV ads be reviewed prior to broadcast is overly broad and, therefore, unconstitutional.

In its letter, PhRMA complains that the mandatory nature amounts to “prior restraint of valuable, constitutionally protected commercial speech.” Instead of a draft guidance that would implement regulations, PhRMA wants the FDA to pursue “notice and comment rulemaking in a tailored, risk-based approach that conforms with the Supreme Court’s directive that the First Amendment mandates that speech restrictions be narrowly drawn.”

PhRMA also maintains the FDA has not offered “empirical evidence” to support its position and, meanwhile, argues that the agency has issued only four warning or so-called untitled letters since 2008 that alleged any regulatory violations stemming from DTC TV ads, even though “hundreds (perhaps thousands)” of ads have aired since then. At the same time, PhRMA questions whether the agency can handle the workload – the FDA estimates 82 ads may require review annually, which will be decided on a case-by-case basis – and argues that delays may dissuade drugmakers from creating ads, which may rob patients of needed health information.

“In order to address these concerns in a manner consistent with the Supreme Court’s First Amendment jurisprudence,” the trade group writes, “PhRMA recommends that FDA reconsider the proposed broad scope of the DTC Review Program and narrowly target those advertisements where it can provide justification supported by empirical evidence to support a legitimate need for a pre-dissemination review and delay of commercial speech and the absence of other less restrictive alternatives,”

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