[Federal Register: April 9, 2007 (Volume 72, Number 67)]
[Notices]
[Page 17559-17561]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ap07-86]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0121]
Use of Medication Guides to Distribute Drug Risk Information to
Patients; Public Hearing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public hearing; request for comments.
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SUMMARY: The Food and Drug Administration (FDA), Center for Drug
Evaluation and Research (CDER), is announcing a public hearing to
obtain feedback on FDA's Medication Guide program, which provides for
the distribution of FDA-approved written patient information for
certain drug and biological products that pose serious and significant
public health concerns. FDA is interested in obtaining public comment
on ways to improve communication to patients who receive Medication
Guides. The purpose of the public hearing is to solicit information and
views from interested persons on specific issues associated with the
development, distribution, comprehensibility, and accessibility of
Medication Guides, which are required to convey risk information to
patients.
Dates and Times: The public hearing will be held on June 12 and 13,
2007, from 8:30 a.m. to 4:30 p.m. on both days. Submit written or
electronic notices of participation by 4:30 p.m. on May 12, 2007.
Written and electronic comments will be accepted until July 12, 2007.
Location: 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).
Addresses: Submit written or electronic notices of participation to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 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.
Submit written or electronic comments to
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.accessdata.fda.gov/scripts/oc/dockets/commentdocket.cfm or
to the Division of Dockets Management. 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 approximately 21 days
after the hearing.
For Registration to Attend and/or to Participate in the Meeting:
Seating at the meeting is limited. People interested in attending
should register 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
or submit a written request for registration
to the Division of Dockets Management (see Addresses) by 4:30 p.m. on
May 12, 2007. Registration is free and will be on a first-come, first-
served basis.
If you wish to make an oral presentation during the open session of
the meeting, you must state this intention on your notice of
participation (see Addresses) and provide an abstract of your
presentation by May 12, 2007. In the notice, submit your name, title,
business affiliation, address, telephone and fax numbers, and e-mail
address. FDA has identified questions and subject matter of special
interest in section II of this document. You should also identify the
subject matter and question number you wish to address in your
presentation, and the approximate time requested for your presentation.
Individuals and organizations with common interests are urged to
consolidate or coordinate their presentations and to request time for a
joint presentation. FDA may require joint presentations by persons with
common interests. We will determine the amount of time allotted to each
presenter and the approximate time that each oral presentation is
scheduled to begin. You must submit final electronic presentations, if
any, to Mary Gross (see Contacts) by no later than June 6, 2007.
Contacts: Mary C. Gross, Safety Policy and Communication Staff
(HFD-001), Center for Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane,
[[Page 17560]]
Rockville, MD 20857, 301-443-5421, e-mail: mary.gross@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is committed to ensuring that prescribers, patients, and their
families have the information needed to support the safe and effective
use of prescription medications. In the Federal Register of December 1,
1998 (63 FR 66378), FDA published its final rule entitled
``Prescription Drug Product Labeling; Medication Guide Requirements''
(effective June 1, 1999). The final rule included provisions that
require the distribution of FDA-approved written patient information,
Medication Guides, for certain prescription drug and biological
products that pose a serious and significant public health concern (see
part 208 (21 CFR part 208)). Medication Guides are intended to provide
information that FDA has determined is necessary to patients' safe and
effective use of drug products. Under Sec. 208.24, manufacturers who
ship drug products for which Medication Guides are required are
responsible for ensuring that Medication Guides are provided in
sufficient numbers to allow distributors, packers, or authorized
dispensers to provide the guides to all patients who receive the drug
product. Alternatively, manufacturers may provide the means for
distributors, packers, or authorized dispensers to produce and provide
Medication Guides to patients.
Section 208.24 also requires each authorized dispenser of a
prescription drug for which a Medication Guide is required to provide
the guide to the patient, or to the patient's agent, when the product
is dispensed, unless exempt from this requirement under Sec. 208.26.
The failure to provide a Medication Guide when such a product is
dispensed would cause the product to be misbranded in violation of the
Federal Food, Drug, and Cosmetic Act (the act) (see sections 502(a),
201(n), and 503(b)(2) of the act (21 U.S.C. 352(a), 321(n), and
353(b)(2)).
Consumers may receive prescription drug information through sources
other than Medication Guides. For example, patient package inserts
(PPIs) are FDA-approved patient information required to be dispensed
with certain drugs such as estrogens (21 CFR 310.515) and oral
contraceptives (21 CFR 310.501) to ensure the safe and effective use of
these products. PPIs are considered part of the product labeling.
Products with Medication Guides do not have PPIs; a required Medication
Guide would replace an existing PPI for a product. Consumer medication
information (CMI) is another source of prescription drug information.
CMI, which is not FDA-approved, is a private sector initiative based on
Public Law 104-180. This law sets specific distribution and quality
goals and timeframes for the private sector distribution of written
prescription drug information to consumers. The law requires that the
Secretary of the Department of Health and Human Services evaluate the
private sector progress toward meeting these goals, including that, by
2006, 95 percent of people receiving new prescriptions would receive
useful written patient information with their prescriptions. For this
public hearing, FDA is not soliciting comments on PPIs or the CMI
initiative. Comments should be limited to the Medication Guide program,
including the questions listed in section II of this document.
A list of drug products with Medication Guides is available on
FDA's Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/offices/ods/medication_guides.htm
.
II. Scope of Hearing
FDA is interested in obtaining public comment on ways to improve
communication to patients consistent with the requirement that
Medication Guides, FDA-approved patient information, be distributed for
selected prescription drugs that pose a serious and significant public
health concern. As stated in Sec. 208.1, patient labeling in the form
of a Medication Guide is required if one or more of the following
circumstances exist:
1. The drug product is one for which patient labeling could help
prevent serious adverse effects.
2. The drug product is one that has serious risk(s) (relative to
benefits) of which patients should be made aware because information
concerning the risk(s) could affect the patients' decision to use, or
continue to use, the product.
3. The drug product is important to health and patient adherence to
directions for use is crucial to the effectiveness of the drug.
The following questions are organized according to consumers,
pharmacies/mail order pharmacies, manufacturers, information vendors/
wholesalers, and academicians/researchers. Specifically, we are seeking
input on the following issues:
Consumers
1. What is the best way for consumers to be informed about the
serious risks of a drug product or other important prescribing
information? Do Medication Guides have a unique or important role in
educating consumers about these risks compared to other written
medication information distributed at the pharmacy? Should the
information be combined or simplified into fewer or one communication
vehicle(s)?
2. How do consumers prefer to receive Medication Guide information
(e.g., paper, e-mail, Internet)? When should they receive Medication
Guide information (e.g., when prescribed, when dispensed, when they
download it from a Web site or e-mail message)?
3. Are Medication Guides easy to read and understand? How can
Medication Guides be improved? Do they serve as useful adjuncts to
counseling by physicians or pharmacists?
Pharmacies/Mail Order Pharmacies
1. Currently, how are you informed that a Medication Guide is
required to be distributed with a specific medication?
2. How do you receive Medication Guides from the manufacturers
(e.g., in what format)? Should the way you receive these be changed? If
so, how?
3. What are the challenges in complying with the Medication Guide
regulation, maintaining an adequate supply of Medication Guides, and
distributing Medication Guides to consumers? What changes should be
made to the Medication Guide program to address these challenges?
4. What steps would you need to take to facilitate electronic
distribution of Medication Guides (e.g., e-mailed to patients)?
5. Do you consider the Medication Guide to be a valuable tool in
counseling patients about drugs with serious risks?
6. Do Medication Guides have a unique role compared to other
communication vehicles that patients receive at the pharmacy? Should
the information be combined or simplified into fewer communication
vehicles?
7. What process improvements could be made to ensure that patients
receive appropriate drug risk information at the pharmacy?
8. What are the advantages and disadvantages of having Medication
Guides to cover a class of drugs versus Medication Guides for each
individual product in a class?
Manufacturers
1. What steps do you take to ensure compliance with the Medication
Guide requirements? What challenges do you encounter in complying with
the requirement to distribute Medication Guides with the product to
pharmacies and others? How do you ensure that pharmacies are receiving
a sufficient supply of Medication Guides?
2. Have means other than paper, such as electronic files, been used
to supply Medication Guides to pharmacies or
[[Page 17561]]
third-party vendors? If so, please describe your experience. If not,
please explain why not.
3. How do you instruct pharmacies that Medication Guides must be
dispensed with certain prescription drugs per Sec. 208.24(d)?
4. Should standardized language and/or a uniform symbol on the
container label be used for the required instruction to dispensers? If
so, please propose standardized language and suggest a uniform symbol
that might be appropriate.
5. What can be done by means of packaging, such as ``unit-of-use,''
to ensure that a Medication Guide is shipped with the drug product so
that it is distributed with each prescription? What are the advantages
and disadvantages of using unit-of-use packaging for any product that
requires a Medication Guide?
6. What are the advantages and disadvantages of developing
Medication Guides to cover a class of drugs rather than having a
separate Medication Guide for each product in a class?
Information Vendors/Wholesalers
1. What challenges or issues regarding distribution of Medication
Guides have you encountered? What changes should be made to the
Medication Guide program to address these challenges?
2. What challenges do information vendors face when offering
electronic versions of Medication Guides in the FDA-approved format?
What ideas do you have regarding how Medication Guides could be
integrated into other consumer information?
Academicians/Researchers
1. Please describe any research that is available regarding how
often patients receive, read, and/or understand Medication Guides.
2. What research is available about Medication Guide
comprehensibility and understandability for the diverse range of health
literacy levels or special populations (e.g., elderly, adolescents,
non-English speaking)? Please describe your recommendations as to how
FDA should modify Medication Guides to more effectively inform a
broader audience about drug risk information.
III. Notice of Hearing Under 21 CFR Part 15
The Commissioner of the FDA 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 Division of
Dockets Management (see Addresses). To ensure timely handling, any
outer envelope should be clearly marked with the docket number listed
in brackets in the heading of this document along with the statement
``FDA Public Hearing: Use of Medication Guides to Distribute Drug Risk
Information to Patients.'' Groups should submit two written copies.
Requests to make a presentation 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 under the docket number listed in brackets in the heading of
this document.
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 (part 10 (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.
Any handicapped persons requiring special accommodations to attend
the hearing should direct those needs to the contact person (see
Contacts).
To the extent that the conditions for the hearing, as described in
this document, conflict with any provisions set out in part 15, this
document acts as a waiver of these provisions as specified in Sec.
15.30(h).
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 and Times). 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 until July 12, 2007. Persons who wish to provide additional
materials for consideration should file these materials with the
Division of Dockets Management (see Addresses). You should annotate and
organize your comments to identify the specific questions to which they
refer (see section II of this document). Two copies of any mailed
comments are to be submitted, 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. Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
V. Transcripts
The hearing will be transcribed as stipulated in Sec. 15.30(b).
The transcript of the hearing will be available 30 days after the
hearing 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 Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, at a
cost of 10 cents per page.
Dated: April 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-6506 Filed 4-6-07; 8:45 am]
BILLING CODE 4160-01-S