[Federal Register Volume 74, Number 100 (Wednesday, May 27, 2009)]
[Notices]
[Pages 25245-25246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-12255]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0253]


Draft Guidance for Industry on Presenting Risk Information in 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

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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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availability of a draft guidance for industry entitled ``Presenting 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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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 Submit written comments on the draft guidance to the 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

[[Page 25246]]

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.
[FR Doc. E9-12255 Filed 5-26-09; 8:45 am]
BILLING CODE 4160-01-S