Comments to the FDA on “Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner”

June 28, 2010

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Comments of the Patient, Consumer, and Public Health Coalition

on

“Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner”

[Docket No. FDA-2009-N-0582 and/or RIN 0910-AG27]

The Patient, Consumer, and Public Health Coalition includes nonprofit organizations and individuals that represent patients, consumers, scientists, and researchers.  We generally support the FDA’s proposed amendments regarding the regulations of direct-to-consumer (DTC) radio and TV ads for prescription drugs.  We also support the FDA’s proposed standards for determining whether the major statement in the ad is presented in a “clear, conspicuous and neutral manner” as required by the Food and Drug Administration Amendments Act of 2007 (FDAAA).

These proposed changes are steps in the right direction, but we continue to have strong reservations about DTC prescription drug ads, and we will continue to urge Congress to restrict or ban DTC ads.  Like all advertising, the goal of DTC ads is to persuade, not to educate, and so DTC ads emphasize the benefits but not the risks of prescription drugs.  When patients are persuaded that a drug will help them, they pressure doctors to prescribe drugs that they may not need or that may be less safe or less effective than less expensive drugs that are available.

We support the FDAAA requirements for DTC radio and TV ads because they strengthen FDA’s existing authority by requiring prescription drug ads to present the major statement “in a clear, conspicuous, and neutral manner, regardless of the manner in which effectiveness information is presented in the advertisement.”[1]

Despite those who justify DTC ads as an important source of information to consumers, it is clear that DTC ads for prescription drugs intentionally focus on persuading consumers to want the drug, and minimize their understanding of the risks or caveats.  For example, researchers at the Harvard School of Public Health and Boston University School of Public Health found that “fewer participants correctly answered risk-related questions than benefits-related questions” after viewing prescription drug ads.[2] In addition, a Kaiser Family Foundation study showed low recall of side effects information from three DTC television advertisements.[3] Researchers at the University of Georgia, Southern Methodist University, and the University of Texas concluded that DTC TV ads “are not doing a good job of meeting the FDA’s fair balance requirement, particularly in presenting risk information in a comprehensible manner.”[4]

In proposing standards for the major statement for radio and TV ads, the FDA reviewed several other federal agencies that regulate the advertising of various products including The Department of Treasury and the Securities Exchange Commission, as well as the Federal Trade Commission (FTC), which regulates over-the-counter drugs.

The FDA noted the common elements of the standards for clear and conspicuous disclosures from the above agencies and they included “the formatting and location of textual information in the disclosure; audio considerations such as pacing, volume, and qualities of speech; and the presence of any distracting elements during the disclosure.”1

We agree with the FDA that these themes should be incorporated into its standards for determining whether the major statement in a radio or TV ad for a prescription drug is presented in a clear and conspicuous way.  We also agree with the FDA that the term “neutral manner” means that the ad information should be presented in an unbiased manner, and not aimed at persuading consumers that the product will help them.

The FDA has straightforwardly laid out the standards for determining whether a major statement is presented in a clear, conspicuous and neutral manner in proposed section 202.1(e)(1)(ii), which states:

  1. “Information is presented in language that is readily understandable by consumers;
  2. Audio information is understandable in terms of the volume, articulation and pacing used;
  3. Textual information is placed appropriately and is presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily; and
  4. The advertisement does not include distracting representations (including statements, text, images, or sounds or any combination thereof) that detract from the communication of the major statement.”1

    We support the four standards listed above for the following reasons:

    1. Information about prescription drugs must be presented in language readily understood by consumers.  This is important because researchers have found that “vocabulary differences in healthcare communications” between patients and providers lead to “potential misunderstandings” that may “result in poor health outcomes and…impact consumer access to health care information…”[5]
    2. Audio information must be presented clearly and at a pace that is comprehensible.  It is unacceptable for prescription drug information (especially side effects/risks) to be raced through as if being uttered by an auctioneer.  Instead, the pace for risk information and other caveats should be identical to the pace for the more positive information.
    3. The text information must be easy to read.  As noted in the Federal Register, “if a television ad presents risk information in a way that would make it difficult to discern (e.g., using white letters on a light gray background or gray letters on a black background), the presentation would lack appropriate conspicuousness…[and] the text must remain on the screen for sufficient time to allow for consumers to identify and read and process the information…[also] visual risk presentations must be in a type size and style that allows them to be easily read by viewers.”1 A 2004 study by Harvard School of Public Health and Boston University School of Public Health researchers found that 83% of the examined ads “contained at least some text that was judged difficult to read (e.g., too small, inadequate contrast with background, or on screen too briefly for coders to read).”[6]
    4. The major statement cannot be allowed to compete with distracting text, images, or sounds.  In a study published earlier this year, researchers found that “irrelevant speech disrupted reading comprehension performance.”[7] The implications for DTC ads are clear: even if a major statement is presented on a TV screen in easily read text, if the audio message that the consumer hears at the same time is different from the visual message, consumers will be distracted and have a difficult time comprehending either the oral or the written message.
    5. In addition to not allowing competing simultaneous oral and written messages, we support FDA’s recommendation to add a fifth standard that would require the major statement be included in both the audio and visual parts of the presentation (which is similar to the FTC standard).  As stated in the Federal Register notice, “Research has shown that presenting the same information in both the audio portion and as visual superimposed text increases the comprehension of that information compared with information presented in only one of those modes.”1 Researchers have found that if the intent is to teach information, it is best to simultaneously provide instructions in audio and visual modes, because the “audio-visual instructional format” is more effective than either mode separately, possibly because “the dual presentation mode allowed processing via separate memory systems.”[8]

      Although not mentioned in the proposed rule, we recommend that the FDA make the quick review of radio and TV DTC ads for newly approved prescription drugs a top priority, and require approval before they can be shown. Newly approved drugs have been tested on only a limited number of people in clinical trials and once they are available to millions of consumers, previously unknown side effects may appear.  For that reason, ads must be very carefully scrutinized before they can be shown to millions of consumers.  In addition, if preliminary findings suggest that a drug’s risks are higher or different than expected, then the radio and TV DTC ads should immediately be stopped.  A revised version of the ad that includes the new risks must be produced before the ad can resume.

      In summary, the public health is jeopardized by the current lax standards and enforcement regarding DTC drugs, and the proposed changes are the minimum requirement to protect consumers.  Pre-review of ads for new products is an important public health safeguard that the FDA should add to the other suggested improvements.

      DTC advertising means that the power of an expensive advertising campaign is used to persuade patients to use medical products that may not be safe or appropriate for them. Rather than empowering consumers, direct-to-consumer advertising exposes consumers to the most effective persuasion that money can buy.  To truly protect consumers, and reduce unnecessary healthcare costs, Congress and the FDA need to do even more than the proposed rules, particularly for drugs that have not been tested for long-term safety on a large population.

      Breast Cancer Action
      Center for Medical Consumers
      The Community Access National Network
      Consumers Union
      National Research Center for Women & Families / Cancer Prevention & Treatment Fund
      Our Bodies Ourselves
      THE TMJ Association, LTD
      U.S. Public Interest Research Group (US PIRG)
      WoodyMatters

      For additional information, contact Paul Brown at (202) 223-4000 or pb@center4research.org


      [1] Federal Register (2010, March 29).  Department of Health and Human Services, Food and Drug Administration, Docket No. FDA-2009-N-0582.  Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner.

      [2] Kaphingst KA, et al. (2005). Comprehension of Information in Three Direct-to-Consumer Television Prescription Drug Advertisements Among Adults With Limited Literacy, Journal of Health Communication, 10:609-619.

      [3] Kaiser Family Foundation (2001).  Understanding the effects of direct-to-consumer prescription drug advertising.  Menlo Park, CA.

      [4] Macias W, et al. (2007).  A Wonderful Life or Diarrhea and Dry Mouth? Policy Issues of Direct-to-Consumer Drug Advertising on Television, Health Communication, 22(3), 241-252.

      [5] Patrick TB, et al. (2001). Evaluation of Controlled Vocabulary Resources for Development of a Consumer Entry Vocabulary for Diabetes, Journal of  Med Internet Research. Jul-Sep; 3(3): e24.

      [6] Kaphingst KA et al. (2004).  A Content Analysis of Direct-to-Consumer Television Prescription Drug Advertisements,  Journal of Health Communication, Volume 9: 515-528.

      [7] Sorqvist P, et al. (2010).  Individual Differences in Susceptibility to the Effects Of  Speech on Reading Comprehension, Applied  Cognitive Psychology 24: 67-76.

      [8] Brewer N, et al. (2004).  Improving Comprehension of Jury Instructions with Audio-Visual Presentation, Applied Cognitive Psychology 18: 765-776.