FDA Opens Comment Period to Discuss First Amendment Issues

NPIcenter News

The FDA announced this week that it was seeking public comment regarding drug and supplement advertising and labels. Recent First Amendment defeats and frustrated efforts to enforce its position policing words used in advertising and labeling have been triggers for this request.

The FDA has been under pressure from both the pharmaceutical and dietary supplements industries in recent months. A few weeks ago, the Supreme Court voted against the FDA’s banning of advertising for a drug compounding company, hoping to prevent distribution of the compounded product. Many in the dietary supplements industry are familiar with First Amendment victories over the FDA in cases in recent years including Pearson versus Shalala, and the agency’s reluctance to budge even after First Amendment defeats.

In the text of the announcement, the FDA states it wishes to “ensure that its regulations, guidances, policies, and practices continue to comply with the governing First Amendment case law. Recent case law has emphasized the need for not imposing unnecessary restrictions on speech. FDA believes this action will help the agency continue to protect the public health, while giving full recognition to evolving judicial decisions.”

The FDA regulates what health claims drug and food companies may make about their products, on labels and in advertising to consumers and doctors ensuring it is not false or misleading.

The agency asks a number of questions, many concerning interpretations of ‘commercial speech’ and the effect of commercial speech on public health. These questions are meant to trigger comment rather than limit the feedback.

  • Are there arguments for regulating speech about drugs more comprehensively than for dietary supplements? Does it make any difference whether the speech is made to learned intermediaries or to consumers?
  • Is FDA’s current position regarding direct-to-consumer and other advertisements consistent with empirical research on the effects of those advertisements? Does the current regulatory approach and its implementation by industry lead to over-prescription of drugs, overuse, increased visits, increased compliance? Does it lead to adequate patient understanding of the potential risks associated with use of products?
  • Can the FDA distinguish claims concerning conventional foods from those relating to dietary supplements, taking into account limits on claims that can be made about foods in the Nutrition Labeling and Education Act, 21 U.S.C. 301, 321, 337, 343, 371? What must an administrative record contain to sustain or deny claims on food labels? How can information best be presented in a succinct but non-misleading fashion? To what extent do assertions in claims need qualifications or disclaimers added to the label to avoid any misconceptions that consumers may draw? Is there a basis to believe that consumers approach claims about conventional foods and dietary supplements differently?
  • Should disclaimers be required to be in the same (or smaller or larger) size of type and given equal prominence with claims?
  • How can warnings be made most effective in preventing harm while minimizing the chances of consumer confusion or inattention?
  • What arguments or evidence can be used to distinguish between advertisements and labels? Does the First Amendment and the relevant social science evidence afford the Government greater latitude over labels?
  • What is the extent of FDA’s ability to regulate speech concerning off-label uses?
  • Do FDA’s speech-related regulations advance the public health concerns they are designed to address? Are there other alternative approaches that FDA could pursue to accomplish those objectives with fewer restrictions on speech?
  • Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority?

The agency is requesting comments within 75 days and parties will then be given 45 days to reply to the comments of others. Full text of the document is available at www.fda.gov/dockets/ecomments. There is some concern among advocates that the agency may be in a cycle that will ultimately loosen its oversight of labeling and advertising. Initial industry response is cautiously optimistic at this chance to alter regulatory enforcement. Many are very supportive of measures to alter or curb the agency’s power and feel this comment period may be an important first step.

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