[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]
[[Page 1694]]
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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