E9-12255. Draft Guidance for Industry on Presenting Risk Information in Prescription Drug and Medical Device Promotion; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Presenting Risk Information in Prescription Drug and Medical Device Promotion.” This guidance responds to stakeholder requests for specific guidance on how FDA evaluates prescription drug and device promotional pieces to determine whether they adequately present risk information. The guidance describes and discusses the factors FDA considers when evaluating prescription drug advertisements (ads), restricted device ads, and prescription drug and device promotional labeling for their compliance with the Federal Food, Drug, and Cosmetic Act (the act) and relevant regulations. The guidance gives examples to illustrate FDA's thinking on these factors and is intended to help regulated industry gain a better understanding of what they should consider as they develop the content and format of their promotional communications.

DATES:

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by August 25, 2009. General comments on agency guidance documents are welcome at any time.

ADDRESSES:

Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:

Regarding human prescription drugs: Kristin Davis, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 Hampshire Ave., Bldg. 22, Silver Spring, MD 20993, 301-796-1200.

Regarding prescription human biological products: Ele Ibarra-Pratt, Center for Biologics Evaluation and Research (HFM-602), Food and Drug Administration, 5515 Security Lane, Rockville, MD 20852-1448, 301-827-3028.

Regarding medical device products: Ann Simoneau, Center for Devices and Radiological Health (HFZ-302), 2094 Gaither Rd., Rockville, MD 20850, 240-276-0100.

Regarding prescription animal drug products: Martine Hartogensis, Center for Veterinary Medicine (HFV-216), 7519 Standish Pl., Rockville, MD 20855, 240-453-6833.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Presenting Risk Information in Prescription Drug and Medical Device Promotion.” FDA has responsibility under the act for regulating promotional labeling for prescription drugs and devices and advertising for prescription drugs and restricted devices. As required by the act and regulations, FDA evaluates the promotional materials for these products to determine whether the promotional materials for the product convey an accurate and nonmisleading net impression about the risks and benefits of the product. The draft guidance describes factors FDA considers when evaluating the risk information in promotional materials for these products.

FDA relies on an extensive body of knowledge regarding human cognition in assessing which factors to consider in evaluating promotional materials and making regulatory decisions about the presentation of risk information. In this draft guidance, FDA discusses both the content and format factors that are relevant to its determination of whether promotional materials adequately present risk information and provides numerous examples to illustrate FDA's thinking on these factors. The agency also makes recommendations about how manufacturers can develop the content and format of their promotional materials to comply with the requirements. The recommendations in the guidance apply to both consumer- and professional-directed promotional materials.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on risk information in prescription drug and medical device promotion. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet may obtain the document at either http://www.fda.gov/​cder/​guidance/​index.htm or http://www.regulations.gov.

Dated: May 13, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.