[Federal Register Volume 67, Number 72 (Monday, April 15, 2002)]
[Notices]
[Pages 18230-18232]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-9096]


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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: 
[email protected]; or on the Internet at 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://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, [email protected].

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://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