[Federal Register: February 20, 2008 (Volume 73, Number 34)]
[Notices]
[Page 9342]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20fe08-79]
[[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Draft Guidance for Industry on Good Reprint Practices for the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availability of a draft guidance for industry entitled ``Good Reprint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 The draft guidance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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Policy (HF-11), Office of Commissioner, Food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 Submit electronic requests for copies of the draft
guidance to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/op/goodreprint.html.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comments on the draft guidance to the Division of Dockets Management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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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electronic access to the draft guidance document.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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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