FDA Publishes Proposed Rule on Broadcast Direct-to-Consumer Prescription Drug Advertisement; the 4 New Standards


On March 29, 2010, FDA published a proposed rule setting forth how it would interpret the Congressionally mandated requirement that “major statements” in broadcast Director-to-Consumer (“DTC”) advertisements for prescription drugs be presented in a “clear, conspicuous and neutral manner." See proposed 21 C.F.R. § 202.1(e), 75 Fed. Reg. 15376 (March 20, 2010).

Under current rules, each DTC broadcast (TV/Radio) advertisement for a prescription drug must contain a “major statement” of the “major side effects and contraindications” of the advertised prescription drug, along with identification of means to obtain the approved labeling for the advertised product (referred to as “adequate provision”). Under current regulations, the “major statement” is required to be “comparable in prominence and readability to the presentation of effectiveness information in the advertisement.”

The Food and Drug Administration Amendments Act of 2007 (“FDAAA”) amended Section 502(n) of the Federal Food Drug and Cosmetic Act by requiring that “[i]n the case of a prescription drug subject to section 503(b)(1) presented directly to consumers in television or radio format and stating the name of the drug and its conditions for use, the major statement relating to side effects and contraindications shall be presented in a clear, conspicuous and neutral manner.” See Section 901(d)(3)(A) of FDAAA.

FDA has proposed four standards that it intends to use in interpreting the Congressional mandate. It will regard a broadcast DTC advertisement to meet the “clear, conspicuous, neutral” test if...

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