[Federal Register: October 3, 2005 (Volume 70, Number 190)]
[Page 57607-57609]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0394]

Food and Drug Administration's Communication of Drug Safety 
Information; Public Hearing

AGENCY: Food and Drug Administration, HHS.

[[Page 57608]]

ACTION: Notice of public hearing; request for comments.


SUMMARY: The Center for Drug Evaluation and Research (CDER) of the Food 
and Drug Administration (FDA) is announcing a public hearing on the 
Center's current risk communication strategies for human drugs. The 
public hearing announced in this notice is part of the agency's ongoing 
effort to improve CDER's risk communication. The purpose of the public 
hearing is to obtain public input on CDER's current risk communication 
tools, identify stakeholders for collaboration and implementation of 
additional tools, and obtain greater understanding of the strengths and 
weaknesses of CDER's existing risk communication.

DATES: The public hearing will be held on December 7 and 8, 2005, from 
8 a.m. to 4:30 p.m. Submit written or electronic notices of 
participation and comments for consideration at the hearing by November 
7, 2005. Written or electronic comments will be accepted after the 
hearing until January 9, 2006. The administrative record of the hearing 
will remain open until January 9, 2006.

ADDRESSES: The public hearing will be held at the National 
Transportation and Safety Board Boardroom and Conference Center, 429 
L'Enfant Plaza, SW., Washington, DC 20594 (Metro: L'Enfant Plaza 
Station on the Green, Yellow, Blue, and Orange Lines). Submit written 
or electronic notices of participation and comments to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852; http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 Transcripts of the hearing will be available for 

review at the Division of Dockets Management 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/default.htm approximately 30 days 

after the hearing.

FOR FURTHER INFORMATION CONTACT: Lee Lemley, Office of Executive 
Programs (HFD-006), Center for Drug Evaluation and Research, Food and 
Drug Administration, 5515 Security Lane, rm. 5107, Rockville, MD 20852, 


I. Background

    FDA approves human drugs and therapeutic biologics when the agency 
determines that the benefits of using a product outweigh the risks for 
the intended population and use. Once a drug product is marketed, 
however, ensuring its safety becomes a complicated responsibility 
shared by many parties. These include health care professionals (who 
must weigh both the risks and the benefits of drugs in deciding whether 
to prescribe a particular drug for a particular patient to achieve an 
optimal therapeutic outcome); patients and caregivers (who must 
understand both the benefits and risks of drugs so they can have 
informed discussions with their health care professionals about their 
medicines and make informed decisions about their use); manufacturers, 
and others. Therefore, it is critical that risk communication be 
timely, accurate, and easily accessible. Information must also be 
communicated in a way that recognizes health literacy limitations, 
including the needs of a multicultural population.
    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. In February 2005, 
the Department of Health and Human Services Secretary Mike Leavitt and 
former FDA Commissioner Lester Crawford announced plans to establish 
new communication channels and expand existing channels to provide 
targeted drug safety information to the public.
    Although outside the scope of this hearing, FDA-approved human drug 
labeling is the primary tool the agency uses to communicate risk and 
benefit to the public. However, CDER also provides drug safety 
information to the public through a variety of other risk communication 
tools. For example, FDA has recently initiated communication tools 
called Patient and Healthcare Professional Information Sheets. In 
addition, FDA releases Talk Papers, Public Health Advisories, Press 
Releases, MedWatch Safety Updates and a monthly video news program for 
health professionals called the Patient Safety News. FDA also conducts 
educational campaigns and conveys drug safety information through the 
CDER Internet site (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder).

II. Scope of the Hearing

    FDA is interested in obtaining public comment on the following risk 
communication tools:
     Patient Information Sheets (for example, see: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/drug/infosheets/patient/adderallpt.htm

     Healthcare Professional Information Sheets (for example, 
see: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/drug/infosheets/hcp/fluoxetinehcp.htm)     Talk Papers (for example see: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/opacom/


     Public Health Advisories (for example, see: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/news/pubpress.htm

     Press Releases (for example, see: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/opacom/hpnews.html

     MedWatch Listserv Safety Updates (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/medwatch/index.html

     Patient Safety News (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/psn)     CDER Educational Campaigns (for example see: http://


     CDER Internet site (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder)

    Specifically, FDA is inviting public comment from external 
stakeholders on the following issues:
    1. What are the strengths and weaknesses of the communication tools 
listed previously in this section of the document?
    2. What information is available about awareness, use, and 
perceptions of the effectiveness of these communication tools by health 
care professionals and by the public in general?
    3. Do these tools provide the right kind and amount of risk and 
other information that health care professionals need to make informed 
decisions about whether to prescribe drug products, and that the public 
needs to make informed decisions about whether to use those products?
    4. How easily accessible and understandable are FDA's Internet-
based sources of drug information?
    5. To what extent do CDER's patient-focused communication tools 
provide useful information for people with low health literacy skills?
    6. What mechanisms should CDER consider to convey risk information 
to special populations (e.g., elderly, non-English speaking)?
    The following topics are outside the scope of this hearing: 
Consumer medication information (and the draft guidance entitled 
``Useful Written Consumer Medication Information [CMI]''); industry 
promotional materials, including Direct to Consumer Advertising; drug 
labeling (including Medication Guides and patient package inserts); and 
the draft guidance entitled ``FDA's `Drug Watch' for Emerging Drug 
Safety Information.'' Comments have been solicited on these issues at 
other times in separate proceedings.

III. Notice of Hearing Under 21 CFR Part 15

    The Acting Commissioner of Food and Drugs (the Acting Commissioner) 
is announcing that the public hearing will be held in accordance with 
part 15 (21 CFR part 15). The presiding officer will

[[Page 57609]]

be the Acting 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 Division of 
Dockets Management (see ADDRESSES and DATES). To ensure timely 
handling, any outer envelope should be clearly marked with the docket 
number listed in brackets in the heading of this notice along with the 
statement ``FDA's Communication of Drug Safety Information; Public 
Hearing.'' Groups should submit two written copies. The notice of 
participation should contain the potential presenter'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 the 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 of the time 
allotted to the presenter and the approximate time that presenter's 
oral testimony 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 schedule will 
be placed on file in the Division of Dockets Management (see ADDRESSES) 
under the docket number listed in brackets in the heading of this 
    Under Sec.  15.30(f), the hearing is informal, and the rules of 
evidence do not apply. No participant may interrupt 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 (21 CFR part 10, subpart C). Under Sec.  10.205 (21 CFR 
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 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/default.htm
, and orders for copies of the 

transcript can be placed at the meeting or through the Division of 
Dockets Management (see ADDRESSES).
    Any handicapped persons requiring special accommodations to attend 
the hearing should direct those needs to the contact person (see FOR 
    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 these provisions as specified in Sec.  

IV. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic notices of participation and 
comments for consideration at the hearing (see DATES). Submit a single 
copy of written or electronic notices of participation and comments, or 
two paper copies of any mailed notices of participation and comments, 
except that individuals may submit one 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.

    Dated: September 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-19759 Filed 9-30-05; 8:45 am]