[Federal Register Volume 74, Number 8 (Tuesday, January 13, 2009)]
[Notices]
[Pages 1694-1695]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-452]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0053]


Guidance for Industry on Good Reprint Practices for the 
Distribution of Medical Journal Articles and Medical or Scientific 
Reference Publications on Unapproved New Uses of Approved Drugs and 
Approved or Cleared Medical Devices; 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 guidance for industry entitled ``Good Reprint 
Practices for the Distribution of Medical Journal Articles and Medical 
or Scientific Reference Publications on Unapproved New Uses of Approved 
Drugs and Approved or Cleared Medical Devices.'' The guidance provides 
drug, biologics, and device manufacturers with the agency's views on 
the distribution of medical journal articles and scientific or medical 
reference publications that discuss unapproved new uses for FDA-
approved drugs or biologics or FDA-approved or cleared medical devices 
to healthcare professionals and healthcare entities.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Policy, Office of the Commissioner, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, rm. 4305, Silver 
Spring, MD, 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your requests. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.
    Submit written comments 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.

FOR FURTHER INFORMATION CONTACT: Jarilyn Dupont, Office of Policy, 
Office of the Commissioner, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 1, rm. 4305, Silver Spring, MD, 20993-0002, 301-
796-4830.

SUPPLEMENTARY INFORMATION:

I. Background

    The guidance provides drug, biologics, and device manufacturers 
with the agency's views on the distribution of medical journal articles 
and scientific or medical reference publications that discuss 
unapproved new uses for FDA-approved drugs (including biologics) or 
FDA-approved or cleared medical devices to healthcare professionals and 
healthcare entities. In the Federal Register of February 20, 2008 (73 
FR 9342), FDA announced the availability of a draft guidance for 
industry entitled ``Good Reprint Practices for the Distribution of 
Medical Journal Articles and Medical or Scientific Reference 
Publications on Unapproved New Uses of Approved Drugs and Approved or 
Cleared Medical Devices.'' FDA received several comments on the draft 
guidance and those comments were considered as the guidance was 
finalized.
    On September 30, 2006, section 401 of the Food and Drug 
Administration Modernization Act (FDAMA) (section 551 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360aaa)) ceased to be in 
effect. The provision described certain conditions under which a drug 
or medical device manufacturer could disseminate medical and scientific 
information discussing unapproved uses of approved drugs and cleared or 
approved medical devices to healthcare professionals and certain 
entities (including pharmacy benefits managers, health insurance 
issuers, group health plans, and Federal or State governmental 
agencies). Section 401 of FDAMA provided that, if the described 
conditions were met, dissemination of such journal articles or 
reference publications would not be considered as evidence of the 
manufacturer's intent that the product be used for an unapproved new 
use. FDA-implementing regulations were codified at 21 CFR part 99. In 
light of the sunset of section 401 of FDAMA and in recognition of the 
public health value to healthcare professionals of receiving scientific 
and medical information, FDA determined that its current views and 
recommendations concerning ``Good Reprint Practices'' for the 
dissemination of medical journal articles and medical or scientific 
reference publications on unapproved uses of drugs and medical devices 
were important. The sunset of the statutory provision eliminated the 
authority of FDA to require submission of articles for the agency's 
review before dissemination by the manufacturers in instances where the 
manufacturer chose to disseminate information under these provisions. 
In the absence of that ability to require such submissions and the fact 
that the implementing regulations are no longer applicable, the agency 
determined that guidance to manufacturers was appropriate because the 
agency no longer reviews individual articles.
    With this guidance, FDA is providing its current views on the 
dissemination of medical journal articles and medical or scientific 
reference publications on unapproved uses of approved drugs and 
approved or cleared medical devices to healthcare professionals and 
healthcare entities. FDA's legal authority to determine whether certain 
distributions of medical or scientific information constitutes 
promotion of an unapproved ``new use,'' or whether such activities 
cause a product to be misbranded or adulterated has not changed.
    Some of the changes made to the guidance based on comments 
received, and on FDA's own initiative, include a specific reference 
encouraging manufacturers to seek approvals and clearance for new 
indications and intended uses for medical products. FDA recognizes the 
value of new indications and uses for approved products and wants these 
to be studied so that patients and healthcare professionals receive 
safe and effective treatments. Many comments suggested that FDA 
continue to require pre-submission of the articles and suggested other 
mandatory review practices. However, given the sunset of section 401 of 
FDAMA these were not within FDA's authority and thus outside the scope 
of this guidance. Section IV of the guidance clarifies a number of 
bullet points to address comments expressing confusion as to some of 
the terms and practices expressed. Additional information was provided 
to distinguish the dissemination of these types of articles from other 
industry practices.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on the dissemination of medical journal 
articles and medical or scientific reference publications on unapproved 
uses of approved drugs and approved or cleared medical devices to 
healthcare professionals and healthcare entities. 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 applicable statutes and regulations.

II. Comments

    Interested persons may, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) written or electronic comments 
regarding the guidance. Submit a single copy of

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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. A copy of the guidance and received comments are 
available for public examination in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/oc/op/goodreprint.html or http://www.regulations.gov.

    Dated: January 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-452 Filed 1-12-09; 8:45 am]
BILLING CODE 4160-01-S