[Federal Register: May 5, 2004 (Volume 69, Number 87)]
[Notices]
[Page 25130-25132]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05my04-87]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2004D-0187, 2004D-0188, and 2004D-0189]
Draft Guidances for Industry on Premarketing Risk Assessment;
Development and Use of Risk Minimization Action Plans; and Good
Pharmacovigilance Practices and Pharmacoepidemiologic Assessment;
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 three draft guidances for industry entitled
``Premarketing Risk Assessment,'' ``Development and Use of Risk
Minimization Action Plans,'' and ``Good Pharmacovigilance Practices and
Pharmacoepidemiologic Assessment.'' All are dated May 2004. These draft
guidances provide guidance to industry on risk management activities
for drug products, including biological drug products, in the Center
for Drug Evaluation and Research (CDER) and the Center for Biologics
Evaluation and Research (CBER). The draft guidances address,
respectively, premarket risk assessment; the development,
implementation, and evaluation of risk minimization action plans for
drug products; and good pharmacovigilance practices and
pharmacoepidemiologic assessment of observational data.
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DATES: Submit written or electronic comments on the draft guidances by
July 6, 2004. General comments on agency guidance documents are welcome
at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidances to the Division of Drug Information (HFD-240), Center for
Drug Evaluation and Research, 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 written
comments on the draft guidances 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.fda.gov/dockets/ecomments.
Identify each set of comments with the corresponding
docket number of the draft guidance as follows: Docket No. [2004D-0187]
``Premarketing Risk Assessment,'' Docket No. [2004D-0188] ``Development
and Use of Risk Minimization Action Plans,'' and Docket No. [2004D-
0189] ``Good Pharmacovigilance Practices and Pharmacoepidemiologic
Assessment.'' See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance documents.
FOR FURTHER INFORMATION CONTACT: For ``Premarketing Risk Assessment'':
Barbara Gould, Center for Drug Evaluation and Research (HFD-550), Food
and Drug Administration, 9201 Corporate Blvd., Rockville, MD 20850,
301-827-2504, or
Patricia Rohan, Center for Biologics Evaluation and Research (HFM-
485), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD
20852-1448, 301-827-3070.
For ``Development and Use of Risk Minimization Action Plans'':
Christine Bechtel, Center for Drug Evaluation and Research (HFD-006),
Food and Drug Administration, 1451 Rockville Pike, Rockville, MD 20852,
301-443-5572, or
Mark Weinstein, Center for Biologics Evaluation and Research (HFM-
300), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD
20852, 301-827-3518.
For ``Good Pharmacovigilance Practices and Pharmacoepidemiologic
Assessment'': Patrick Guinn, Center for Drug Evaluation and Research
(HFD-6), Food and Drug Administration, 5515 Security Lane, Rockville,
MD 20852, 301-443-5590, or
Miles Braun, Center for Biologics Evaluation and Research (HFM-
220), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD
20852, 301-827-6090.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of three draft guidances for
industry entitled ``Premarketing Risk Assessment,'' ``Development and
Use of Risk Minimization Action Plans,'' and ``Good Pharmacovigilance
Practices and Pharmacoepidemiologic Assessment.'' These three guidances
were produced in part to fulfill FDA's commitment to certain risk
management performance goals agreed to in relation to the Prescription
Drug User Fee Act upon its reauthorization in June 2002. As an initial
step, FDA announced on March 7, 2003 (68 FR 11120), the availability of
three concept papers. Each concept paper focused on one aspect of risk
management. FDA held a public workshop on April 9-11, 2003, to obtain
comment on the concept papers. The comments submitted on the concept
papers and at the public meeting were considered in developing these
draft guidances.
These three draft guidances address risk management issues
pertinent to the successive stages of a product's lifecycle,
specifically: (1) During medical product development, (2) during
product application review and approval, and (3) during the
postmarketing period. The approaches recommended in the draft guidances
should not be viewed as a new collection of generalized and discrete
tools for risk minimization but rather as part of much broader,
ongoing, and comprehensive efforts to provide additional guidance to
industry on measures that can be employed to minimize the risks while
preserving benefits of medical products.
The draft guidances recommend that sponsors consider specific risk
minimization efforts beyond routine risk minimization measures for the
few products presenting unusual types or levels of risk. In these
circumstances, using strategies that go beyond routine risk assessment
and minimization may further improve the product's benefit-risk
balance. FDA is specifically soliciting public comment on how to best
characterize the types and levels of risk that might suggest the need
for a risk management plan.
FDA understands that risk management programs generate costs and
place new burdens on product developers, health care practitioners, and
patients. FDA recommends that, whenever possible, sponsors give every
consideration to using the least burdensome method to achieve the
desired public health outcome. For example, making increasing use of
automatic reporting and future notification systems for adverse events
will help the agency learn quickly of potential problems. Use of
networks for electronic prescribing can enable the real-time, efficient
collection of data on adverse events and even alert physicians to
adverse events at the time of prescribing.
As new products are developed, FDA recommends that sponsors seek to
identify risk signals as early as possible in a product's development
cycle, to evaluate the risks, to communicate predictable risk and
benefit information effectively and thoroughly, and to employ efforts
to manage these risks as efficiently as possible.
These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidances,
when finalized, will represent the agency's current thinking on these
topics. They do not create or confer any rights for or on any person
and do 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 on the draft guidances.
Two copies of mailed comments are to be submitted, except that
individuals may submit one copy. Comments are to be identified with the
docket numbers found in brackets in the heading of this document.
Identify each set of comments with the corresponding docket number of
the draft guidance as follows: Docket No. [2004D-0187] ``Premarketing
Risk Assessment,'' Docket No. [2004D-0188] ``Development and Use of
Risk Minimization Action Plans,'' and Docket No. [2004D-0189] ``Good
Pharmacovigilance Practices and Pharmacoepidemiologic Assessment.'' The
draft guidances 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.
III. Paperwork Reduction Act of 1995
These guidances contain information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection(s) of information in the guidances were approved under OMB
control numbers 0910-0001 (until
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March 31, 2005) and 0910-0338 (until August 31, 2005).
IV. Electronic Access
Persons with access to the Internet may obtain the documents at
http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.
ets/default.htm.
Dated: April 26, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-10028 Filed 5-4-04; 8:45 am]
BILLING CODE 4160-01-S