[Federal Register Volume 73, Number 34 (Wednesday, February 20, 2008)]
[Notices]
[Page 9342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 08-746]



[[Page 9342]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry on Good Reprint Practices for the 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availability of a draft guidance for industry entitled ``Good Reprint 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.'' The draft guidance 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 health care professionals and health care entities.

DATES: Submit written or electronic comments on the draft guidance by 
April 21, 2008. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Policy (HF-11), Office of Commissioner, Food 
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. Submit electronic requests for copies of the draft 
guidance to http://www.fda.gov/oc/op/goodreprint.html. 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comments on the draft guidance to the Division of Dockets Management 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electronic access to the draft guidance document.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: Jarilyn Dupont, Office of Policy, 
Office of Commissioner, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-3360.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing 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.'' The draft 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 health care 
professionals and health care entities.
    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 health care 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 health care professionals of receiving 
scientific and medical information, FDA is providing 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. 
FDA's legal authority to determine whether distribution 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.
    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 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 health care professionals and 
health care 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 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.
    Please note that as of January 15, 2008, the FDA Web site 
transitioned to the Federal Dockets Management System (FDMS). FDMS is a 
Government-wide, electronic docket management system. Electronic 
submissions will be accepted by FDA only through FDMS.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: February 13, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 08-746 Filed 2-15-08; 8:45 am]
BILLING CODE 4160-01-S