F.  FDA Seeks Public Comment

on Its First Amendment Approach

 

      Following a string of First Amendment setbacks in federal courts, the Food and Drug Administration in May 2002 published a notice requesting public comment on its First Amendment policies.  The notice was a milestone.  It acknowledged  that the FDA faced constitutional limitations in regulating speech about medical products, and went so far as to seek advice on how the agency might comply with the First Amendment.  Request for Comment on First Amendment Issues, FDA Docket No. 02N-0209, 67 Fed. Reg. 34,942 (2002) (“Request”). 

 

Background

      For years, the FDA acted as if its regulatory actions were immune from First Amendment scrutiny.  This stance was the result of three factors: (1) the FDA’s assertion that speech about pharmaceutical products was a “special case” because drugs, without explanatory words, were merely useless (and potentially dangerous) chemicals; (2) the unusual arrangement in place since 1962 by which the FDA regulates not only pharmaceutical products themselves, but also the speech of pharmaceutical companies about those products; and (3) the FDA’s expansive definition of “promotional activity” to include the regulation of virtually all speech involved in drug labeling, advertising, and marketing.  The FDA’s definition of “labeling” alone includes not only packaging materials, but also mailing pieces, calendars, catalogs, letters, videos, audio recordings, and myriad other forms of speech not remotely connected to the product label.  21 C.F.R. Sec. 202.1 (1)(2).

      The FDA’s expansive reach went largely unchecked because drug companies, beholden to the agency for lucrative new-drug approvals, were reluctant to antagonize the FDA over free-speech issues.

      The tide began to turn in the early 1990s when the nonprofit Washington Legal Foundation (WLF) challenged the FDA in federal court over the agency’s attempts to restrict information about “off-label” uses of drugs.  WLF claimed that the FDA’s efforts to prohibit drug makers from distributing textbook reprints and journal articles, and to regulate the content of medical seminars about such off-label (but legal) uses, violated drug makers’ First Amendment rights.

      After a protracted legal battle, the U.S. District Court for the District of Columbia agreed that the FDA had indeed overstepped the First Amendment boundary.  Washington Legal Foundation v. Friedman, 13 F. Supp. 2d 51 (D.D.C. 1998); Washington Legal Foundation v. Friedman, 56 F. Supp. 2d 81 (D.D.C. 1999).  In 2001, the same court ruled that the FDA had violated the commercial speech rights of dietary supplement manufacturers and sellers seeking FDA approval for a folic acid health claim.  Pearson v.  Shalala, 130 F. Supp. 2d 105 (D.D.C. 2001).  And in April 2002, the U.S. Supreme Court upheld the First Amendment right of pharmacists to advertise “compounded” drugs.  Thompson v. Western States Medical Center, 535 U.S. 357 (2002).  (See Chapter A in this section.)

 

Revealing Questions

      These rulings, and other lower court decisions upholding commercial speech rights at the FDA’s expense, appear to have spurred the agency to seek comment on its First Amendment policies.  “FDA must continue to pursue regulation of products for purposes of protecting the public with a full recognition of the evolving judicial landscape in areas that directly affect its ability to regulate words.”  Request at para. 6.

      The Request posed a total of 31 questions on which the agency sought comment, divided into eight sections.  The initial questions in several of the sections give a sense of the FDA’s scope of interest:

 

·        Are there arguments for regulating speech about drugs more comprehensively than, for example, about dietary supplements?

·        Is FDA’s current position regarding direct-to-consumer and other advertisements consistent with empirical research on the effects of those advertisements, as well as with relevant legal authority?

·        May 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?

·        What arguments or social science evidence, if any, can be used to support distinguishing between claims made in advertisements and those made on labels?

·        Would permitting speech by manufacturer, distributor, and marketer about off-label uses undermine the [Federal Food, Drug, and Cosmetic] act’s requirement that new uses must be approved by the FDA?

·        Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority?

 

      A number of follow-up questions show a keen interest in the effects of drug advertising and promotion.  The FDA wonders, for instance, if the current regulatory approach and its implementation by industry leads to over-prescription of drugs, more visits to physicians, and adequate treatment for under-diagnosed diseases.  The agency also asks if the current scheme creates “impediments to the ability of doctors to give optimal medical advice or prescribe optimal treatment.”  Request at para. 9.

      The questions also reveal the FDA’s growing interest in regulating dietary supplements and the health claims accompanying them, which was the subject of Pearson.  Queries about disclaimers and consumer warnings suggest the FDA may be considering a more lenient approach toward health claims generally, including those for food products, provided the claims are countered with adequate cautions.

 

Central Hudson Sensitive

      Many of the questions seem designed to elicit a fuller understanding of what the FDA must do to comply with the Supreme Court’s test for commercial speech regulations contained in Central Hudson Gas & Electric Corp. v. Public Service Commission, 447 U.S. 557 (1980).  In recent court rulings, the agency has tended to run afoul of the third and fourth parts of the four-part test. 

      Part 3 requires that a speech restriction directly and materially advance the government’s substantial interest in restricting speech.  Thus, the Request asks: “Do FDA’s speech-related regulations advance the public health concerns they are designed to address?”  Part 4 of Central Hudson requires that a regulation be narrowly tailored to achieve the government’s interest.  The Request asks: “Are there other alternative approaches that FDA could pursue to accomplish those objectives with fewer restrictions on speech?”

       Other questions aim at establishing quantifiable measures on which to base agency actions.  The Request repeatedly asks commenters for an “evidentiary basis,” “empirical research,” “relevant authority,” “social science research,” “social science evidence,” and the information an administrative record must contain to sustain a challenge.  These references are a direct nod to recent commercial speech rulings in which courts have demanded empirical data – rather than mere speculation – to demonstrate that a regulation directly and materially advances the government’s interest. 

 

Reaction to Inquiry Mixed

      The FDA drew both kudos and complaints for undertaking the First Amendment inquiry.  Manufacturers of pharmaceuticals, dietary supplements, and food products generally welcomed the initiative, praising the agency for changing with the times and being willing to reevaluate its First Amendment policies.  Consumer groups and other critics, however, warned the FDA not to use the inquiry as an excuse to loosen regulations on drug promotion and health claims.  Sen. Edward M. Kennedy (D-Mass.) and Rep. Henry Waxman (D-Calif.) were among lawmakers who wrote the FDA on Sept. 13, 2002 – the day comments were due – angrily urging the agency to drop the proceeding.   At year end, however, the FDA was sifting through hundreds of comments and reply comments as it pondered possible revisions to its First Amendment approach.

 

--Richard T. Kaplar

 

The Media Institute filed comments in response to the FDA’s Request for Comment on First Amendment Issues, urging a return to established rulemaking procedures and a heightened awareness of First Amendment concerns.