[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