The Food and Drug Administration recently published proposed regulations for broadcasting direct-to-consumer prescription drug ads, with a comment period open until June 28.

Under the FDA Amendments Act of 2007, the agency is required to provide guidance on a provision that requires drug manufacturers to disclose information related to the major side effects of drugs in a “clear, conspicuous, and neutral manner.”

“FDA recognizes that these standards require judgment in their application,” the notice of the proposed regulations said. “Therefore, the agency does not intend to prescribe a set formula for ‘clear, conspicuous, and neutral’ major statements because there is more than one way to achieve these standards in a television or radio ad. FDA intends to be flexible enough to consider the variety of techniques sponsors may use to appropriately convey required risk information in prescription drug ads.”

The proposed regulations set out four requirements for the information to be acceptably clear:

  • The information must be presented in language that is readily understandable by consumers; medical jargon is not acceptable. For example, if a drug’s prescribing information includes a risk of “syncope,” a direct-to-consumer ad should mention a risk of “fainting” rather than using the medical term “syncope,” according to the proposed regulations.
  • Audio information must be understandable in terms of volume, articulation, and pacing; “rushed” reading by an announcer will not comply. “Risk information must be presented at a pace that allows the audience to hear and process it,” the proposed regulations said.
  • Text must be placed appropriately and presented for sufficient duration and in a size and style of font that allows the information to be read easily. White letters on a gray background, or gray letters on a black background, would not be conspicuous enough.
  • The advertisement should not include distracting representations (images, text, music, graphics, or any combination thereof) that take away from the communication of the major statement – particularly if the distractions highlight benefits of the drug.

Several examples are provided of unacceptable advertisements, including ads that use vague information such as “some patients experience this side effect.” Instead, the ad should accurately convey the frequency of the risk – “more than half of patients,” for example – of the adverse event.

If the proposed regulations are finalized, they will go into effect 90 days after their publication in the Federal Register.

Why it matters: Drug manufacturers should take a close look at the proposed rules as they include greater detail about how the FDA will review direct-to-consumer broadcast advertisements. The FDA noted that it took a random sample of 35 drug ads that aired in 2008 and found that one-third could be judged as being in violation of the newly proposed regulations. Any ad that airs after the effective date will be required to comply with the regulations, so drug manufacturers should follow the road map provided by the proposed regulations for both new and existing advertisements.