Law firm identifies failings in US FDA proposed rule that allows for flexibility in DTC drug ads

The US Food and Drug Administration has recently published a proposed rule to amend its direct-to-consumer (DTC) regulations to require that prescription drug advertisements present information about side effects and contraindications in a 'clear, conspicuous, and neutral manner.'

Current regulations, found in 21 C.F.R. 202.1, require the disclosure of major side effects and contraindications (commonly known as the 'major statement') in either the audio or audio and visual parts of an advertisement and that they be presented in a comparable manner to any statements regarding the drug's efficacy, explains US law firm Hyman, Phelps & McNamara in its FDA Law Blog

With the passage of the FDA Amendments Act of 2007 (FDAAA), Section 502(n) of the Food and Drug Cosmetic Act now requires that the major statement in television and radio advertisements to consumers be presented in a 'clear, conspicuous and neutral manner.' The agency looked to standards set by other agencies for guidance, including the Federal Trade Commission, the Department of Treasury and the Securities and Exchange Commission. The law firm points out that the FDA now proposes to amend Section 202.1(e)(1) to include four criteria as to when a major statement would be considered 'clear, conspicuous and neutral.'