Blog Post #3: Direct to Consumer Prescription Drug Advertisements

Rosalyn Finlayson

October 30, 2010

Name of Guidance:

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

Status of Guidance

Proposed Rule

Date of Guidance

March 29, 2010

Link to the Guidance

http://edocket.access.gpo.gov/2010/pdf/2010-6996.pdf

Target audience

Manufacturers of prescription drugs, advertising agencies and the general public.

Laws An Regulations Referenced

21 USC 352 Section 502n: stipulations for “true statements” in advertising

21 CFR 202.1: describes requirements for print and broadcast advertising

58 FR 42364: outlines “clear and conspicuous” disclosure in advertising

63 FR 24996: outlines “clear and conspicuous” disclosure in audio advertisements

Public Law 102-556: Telephone Disclosure & Dispute Resolution Act of 1992

Public Law 110-85 Section 901: Food Drug Administration Amendments Act of 2007

Public Law 106-102: Gramm Leach Bliley Act

Summary

This proposed rule is a follow up to the Food & Drug Administrations May 2009 guideline for Presenting Risk Information in Prescription Drug and Medical Device Promotion. Under this proposed rule the authority of the FDA would expand from making recommendations to having legal authority to enforce compliance. The proposed rule clarifies terminology of the following terms; neutral, major statement, and clear and conspicuous nature. Discussed in this proposal are the Eastern Research Groups findings of peer-reviewed literature on direct to consumer advertising published from 2004 through 2008. The proposed rule also discusses the FDA’s decision to adhere to standards that are consistent with previous regulations adopted by a number of other federal agencies. The proposed effective date of this particular rule will be 90 days after publication in the Federal Register. The FDA solicits public comment on several segments of this proposed rule.

Rationale

This proposed rule was developed because of the growing body of research indicating that there is an influence of direct to consumer advertising on public health. The FDA has taken into consideration the research findings of the Eastern Research Group and revised some of the recommendations contained in the May 2009 guideline Presenting Risk Information in Prescription Drug and Medical Device Promotion. The FDA has revised its previous recommendations in order to be aligned with the disclosure regulations and standards presented by other federal agencies. This proposed rule could potentially have a positive effect on the health outcomes of the general public through better communication of risk information in prescription drug television and radio advertisements.

Resulting Recommendations

Based on the regulations of a number of other federal agencies and the findings presented by the Eastern Research Group the FDA is presenting the following regulations in this proposed rule.

All risk factors, major side effects and any contraindications of prescriptions drugs must be presented in a neutral, clear and conspicuous manner regardless of how the benefit is presented.

Communication of risk information in major statements in consumer-directed prescription drug advertisements must be presented so that the consumer receives a fair and accurate impression of the drug being promoted.

The major statement in television advertisements must be included in both the audio and visual parts of the presentation.

Advertisements for prescription drugs must follow FTC regulations for the ease of comprehension of the language as well as the formatting and location of textual information in the disclosure.

Advertisements for prescription drugs must follow FTC regulations for the audio components of advertisements such as pacing, volume and quality of speech.

Impact

The implementation of this proposed rule would further regulate the manner in which manufacturers of prescription drugs would be able to present drug information in directly to consumer advertisements. This proposed rule is designed to ensure information about a prescription drug is clearly presented in advertisements targeting the general public.