[Federal Register: April 15, 2002 (Volume 67, Number 72)]
[Notices]
[Page 18230-18232]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15ap02-86]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02N-0115]
Risk Management of Prescription Drugs; Public Hearing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public hearing; request for comments.
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SUMMARY: The Center for Drug Evaluation and Research (CDER) of the Food
and Drug Administration (FDA) is announcing a public hearing on the
agency's approach to risk management of prescription drugs. In May
1999, FDA published ``Managing the Risks From Medical Product Use,''
which laid a framework for the agency's efforts to reduce the risks
involved with medical product use. The public hearing announced in this
notice is part of the agency's ongoing efforts to improve CDER's risk
communication and to develop new and effective risk management tools.
The purpose of the
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hearing is to obtain public input on improving risk management of
prescription drugs; identify stakeholders for further collaboration on
development and implementation of risk management tools; obtain greater
understanding of the strengths and weaknesses of existing risk
management tools, which should help guide improvements or creation of
new tools; and obtain input on strategies to assess the effectiveness
of tools used for risk management of prescription drugs.
DATES: The public hearing will be held on Wednesday, May 22, 2002, from
8 a.m. to 4:30 p.m. Submit written or electronic notices of
participation and comments for consideration at the hearing by April
23, 2002. Written or electronic comments will be accepted after the
hearing until June 21, 2002.
ADDRESSES: The public hearing will be held at the National
Transportation Safety Board Boardroom and Conference Center, 429
L'Enfant Plaza, SW., Washington, DC 20594 (Phone: 202-314-6421; Metro:
L'Enfant Plaza Station on the green, yellow, blue, and orange lines).
Submit written or electronic notices of participation and comments to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852; email:
FDADockets@oc.fda.gov; or on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdocket.cfm.
Transcripts of the hearing will be available for review at the Dockets
Management Branch (address above) and on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.
FOR FURTHER INFORMATION CONTACT: Christine Bechtel, Center for Drug
Evaluation and Research (HFD-006), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-5458, bechtelc@cder.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA approves medical products when the agency determines that the
benefits of using a product outweigh the risks for the intended
population and use. The product must be labeled with adequate
information on its risks and benefits. The labeling must also provide
sufficient information to ensure the product is safely used to produce
the stated effect. Labeling is given considerable emphasis because it
is the primary tool the agency uses to communicate risk and benefit to
the public. Once the medical product is marketed, however, ensuring
safety becomes a complicated responsibility shared by many parties,
including health care providers, manufacturers, patients, and others.
New information on safety that needs dissemination often arises
postmarketing. Occasionally, a product's safety and efficacy profile
changes, resulting in the need for safety intervention beyond labeling
(e.g., to protect the public or a population subgroup from increased
risks). When such situations arise, effective risk management tools are
needed.
Many critics have expressed concern that the current risk
management system for drugs is inadequate. The number of drugs
available on the market is increasing along with their complexity. The
potential for interactions among various treatments is also growing and
is beyond the ability of many busy physicians to track. In addition,
changes in the health care delivery system, advertising, third-party
payer programs, and other forces are challenging the current risk
management system. Recent studies of the effectiveness of FDA's
traditional risk communication tools (i.e., the ``dear health care
practitioner letter'' and the black box warning in product labeling)
have demonstrated that these tools have limited effect in changing the
behavior of health care providers with regard to prescribing and
monitoring patients' health (Refs. 1, 2, and 3).
II. Scope of the Hearing
FDA is interested in obtaining public comment on the following
issues:
A. Risk Communication
What improvements are needed to enhance communication
about safety issues for drugs?
What improvements are needed to communicate information
about the efficacy of drugs?
What are the strengths and weaknesses of the agency's
current risk labeling approach?
How can communication with health care practitioners
become more effective (e.g., improve the ``dear health care
practitioner letter'' and other current communication strategies)?
What other steps should FDA be taking to communicate risks
and benefits?
B. Tools for Risk Management
What methods should FDA be using to manage risk?
What new tools can be created to better address specific
drug risks?
What are the advantages and disadvantages of restricted
marketing as a risk management tool?
What risk interventions can FDA initiate for pharmacists,
physicians, patients, and drug manufacturers?
C. Evaluation of Risk Management Strategies and Interventions
What risk management interventions should be studied for
effectiveness?
What criteria should be used to judge if a risk management
intervention is effective?
III. Notice of Hearing Under 21 CFR Part 15
The Commissioner of Food and Drugs (the Commissioner) is announcing
that the public hearing will be held in accordance with part 15 (21 CFR
part 15). The presiding officer will be the Commissioner or his
designee. The presiding officer will be accompanied by a panel of FDA
employees with relevant expertise.
Persons who wish to participate in the part 15 hearing must file a
written or electronic notice of participation with the Dockets
Management Branch (see ADDRESSES) before April 23, 2002. To ensure
timely handling, any outer envelope should be clearly marked with the
docket number listed at the head of this notice along with the
statement ``Risk Management of Prescription Drugs Hearing.'' Groups
should submit two written copies. The notice of participation should
contain the person's name; address; telephone number; affiliation, if
any; the sponsor of the presentation (e.g., the organization paying
travel expenses or fees), if any; a brief summary of the presentation;
and approximate amount of time requested for the presentation. The
agency requests that interested persons and groups having similar
interests consolidate their comments and present them through a single
representative. After reviewing the notices of participation and
accompanying information, FDA will schedule each appearance and notify
each participant by telephone of the time allotted to the person and
the approximate time the person's oral presentation is scheduled to
begin. If time permits, FDA may allow interested persons attending the
hearing who did not submit a written or electronic notice of
participation in advance to make an oral presentation at the conclusion
of the hearing. The hearing schedule will be available at the hearing.
After the hearing, the hearing schedule will be placed on file in the
Dockets Management Branch under the docket number listed at the head of
this notice.
Under Sec. 15.30(f), the hearing is informal, and the rules of
evidence do not apply. No participant may interrupt
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the presentation of another participant. Only the presiding officer and
panel members may question any person during or at the conclusion of
each presentation.
Public hearings under part 15 are subject to FDA's policy and
procedures for electronic media coverage of FDA's public administrative
proceedings (part 10, subpart C (21 CFR part 10, subpart C)). Under
Sec. 10.205, representatives of the electronic media may be permitted,
subject to certain limitations, to videotape, film, or otherwise record
FDA's public administrative proceedings, including presentations by
participants. The hearing will be transcribed as stipulated in
Sec. 15.30(b). The transcript of the hearing will be available on the
Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets, and orders for copies of
the transcript can be placed at the meeting or through the Dockets
Management Branch (see ADDRESSES).
Any handicapped persons requiring special accommodations to attend
the hearing should direct those needs to the contact person (see FOR
FURTHER INFORMATION CONTACT).
To the extent that the conditions for the hearing, as described in
this notice, conflict with any provisions set out in part 15, this
notice acts as a waiver of those provisions as specified in
Sec. 15.30(h).
IV. Request for Comments
Interested persons may submit to the Dockets Management Branch
(address above) written or electronic notices of participation and
comments for consideration at the hearing by April 23, 2002. To permit
time for all interested persons to submit data, information, or views
on this subject, the administrative record of the hearing will remain
open following the hearing until June 21, 2002. Persons who wish to
provide additional materials for consideration should file these
materials with the Dockets Management Branch (see ADDRESSES) by June
21, 2002. Two copies of any written comments are to be submitted,
except that individuals may submit one copy. Comments are to be
identified with the docket number at the heading of this document.
Received comments may be seen in the office above between 9 a.m. and 4
p.m., Monday through Friday.
V. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Jones, J. K., D. Fife, S. Curkendall et al., ``Coprescribing
and Codispensing of Cisapride and Contraindicated Drugs,'' Journal
of the American Medical Association, 286:1607-1609, 2001.
2. Graham, D. J., C. R. Drinkhard, D. Shatin et al., ``Liver
Enzyme Monitoring in Patients Treated With Troglitazone,'' Journal
of the American Medical Association, 286:831-833, 2001.
3. Smalley, W., D. Shatin, D. K. Wysowski et al.,
``Contraindicated Use of Cisapride: Impact of Food and Drug
Administration Regulatory Action,'' Journal of the American Medical
Association, 284: 3036-3039, 2002.
Dated: April 8, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-9096 Filed 4-12-02; 8:45 am]
BILLING CODE 4160-01-S