[Federal Register Volume 74, Number 131 (Friday, July 10, 2009)]
[Notices]
[Pages 33265-33267]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-16335]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0295]
Providing Effective Information to Consumers About Prescription
Drug Risks and Benefits; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) Center for Drug
Evaluation and Research (CDER), in collaboration with FDA's Office of
the Commissioner (OC), is announcing a public workshop entitled
``Providing Effective Information to Consumers About Prescription Drug
Risks and Benefits.'' This public workshop is intended to explore
potential approaches that will result in written
[[Page 33266]]
prescription drug information for consumers that is comprehensible,
accurate, and easy to access.
DATES: The public workshop will be held on September 24 and 25, 2009,
from 8 a.m. to 5:30 p.m. Written or electronic comments on the posted
information or on the workshop must be submitted to the docket by
November 25, 2009.
ADDRESSES: The public workshop will be held at the Hilton Washington
DC/North Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. All comments should be identified with the docket number found
in the brackets in the heading of this document. A transcript of
plenary sessions will be available for review at the Division of
Dockets Management and on the Internet at http://www.regulations.gov
approximately 30 days after the workshop.
FOR FURTHER INFORMATION CONTACT: Mary Gross, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6178, Silver Spring, MD 20993, 301-796-
3519, e-mail: mary.gross@fda.hhs.gov; or Marsha Holloman, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6173, Silver Spring, MD 20993, 301-796-
0731, e-mail: marsha.holloman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In order to make informed decisions about health care, patients
need to have easy access to up-to-date and accurate information about
the risks and benefits of the prescription drugs they take. Currently,
consumers are receiving multiple pieces of written information with
their prescription drugs from the pharmacy, information that is
developed and distributed through various sources. Over the years, FDA
has undertaken a number of initiatives in an effort to ensure that
consumers receive useful written information when they obtain their
prescription medicines from the pharmacy. The following is a short
description of both required and voluntary patient labeling.
Since 1968, FDA regulations have required that patient package
inserts (PPIs), written specifically for patients, be distributed to
patients when certain prescription drugs, or classes of prescription
drugs are dispensed (Sec. 310.501 (21 CFR 310.501) and Sec. 310.515 (
21 CFR 310.515)). PPIs for estrogens (Sec. 310.515) and oral
contraceptives (Sec. 310.501) are FDA-approved and are considered part
of the product labeling. They must be given to the patient when the
product is dispensed. Other PPIs are submitted to FDA voluntarily by
manufacturers and approved by FDA, but their distribution is not
mandated by regulation. For example, many PPIs have been submitted to
the agency for review in response to the FDA draft guidance entitled
``Brief Summary: Disclosing Risk Information in Consumer-Directed Print
Advertisements'' issued in April 2001. Under the Food and Drug
Administration Amendments Act (FDAAA), FDA can require a PPI as part of
a risk evaluation and mitigation strategy (REMS).
Medication Guides are patient labeling (21 CFR part 208) and
accompany those drugs deemed by the agency to have serious and
significant risks. Medication Guides address issues that are specific
to particular drugs or in some cases, drug classes, and they contain
FDA-approved information that can help patients avoid serious adverse
reactions. Medication Guides are developed by manufacturers and
reviewed by FDA and they are required to be distributed by pharmacies
with each prescription. In the Federal Register of August 24, 1995 (60
FR 44182), FDA published a proposed rule entitled ``Prescription Drug
Product Labeling: Medication Guide Requirements.'' In the Federal
Register of December 1, 1998 (63 FR 66378), the final rule with the
same title was published. On June 12 and 13, 2007, a public meeting
entitled ``Use of Medication Guides to Distribute Drug Risk Information
to Patients'' was held. The public testified that the Medication Guide
distribution process needed improvement including providing a means for
electronic printing, waiving certain format requirements and ensuring
that a complete list of Medication Guides were posted in a central
location on the Web. Some expressed the view that Medication Guides
should be shorter and easier to read. Finally, comments indicated that
the sources of patient information should be consolidated into a single
document.
In September 2007, Congress amended the Federal Food, Drug, and
Cosmetic Act and included Medication Guides as one potential element of
a REMS. FDA may require a sponsor to develop a REMS if it determines a
REMS is necessary to ensure that the benefits of a drug outweigh the
risks. Between September 2007 when FDAAA was enacted and May 31, 2009,
FDA has approved 50 REMS with Medication Guides, including 43 REMS that
consisted only of a Medication Guide and a timetable for assessment of
the REMS. The use of Medication Guides as part of REMS, particularly as
part of REMS that affect whole classes of drugs, has provided further
impetus to evaluate different approaches to providing the type of
prescription drug information that is normally provided in a Medication
Guide to consumers.
Consumer Medication Information (CMI) is based on Public Law 104-
180. Under Public Law 104-180, prescription drug information is
developed and distributed by the private sector and the development of
this information is voluntary. Public Law 104-180 adopted certain goals
and timeframes consistent with FDA's proposed rule (60 FR 44182) which
were:
By the year 2000, 75 percent of people receiving new
prescriptions would receive ``useful'' patient information with their
prescriptions; and
By the year 2006, 95 percent of people receiving new
prescriptions would receive ``useful'' written patient information with
their prescriptions.
FDA was charged with evaluating the private sector's progress in
meeting these goals and to establish guidelines for usefulness
criteria. By passing this legislation, FDA was also enjoined from
further rulemaking that would require patient information for all
prescription drugs, so long as these goals were met within specified
timeframes.
CMI has failed to meet the statutory goals based on two independent
evaluations performed in 2001 and 2008. In the 2001 evaluation, 89
percent of patients received some form of information, with 50 percent
of this information determined to be useful. On July 6, 2006, FDA
issued a guidance entitled ``Useful Written Consumer Medication
Information (CMI).'' The second CMI evaluation, conducted in 2008,
found that patients received information 94 percent of the time, but
only 75 percent of that information was deemed useful, missing the goal
set out in Public Law 104-180 that 95 percent of consumers would
receive useful prescription drug information by 2006.
With a CMI effort that does not meet Congressional goals and
reports indicating that many patients may not be understanding (or even
receiving) Medication Guides from the pharmacy, FDA is reexamining the
current process whereby prescription drug information is developed and
disseminated to patients.
[[Page 33267]]
By September 21, 2009, FDA will post the following information:
Workshop agenda;
FDA Issues Paper that describes past history, current
challenges, and possible approaches to improve the current system;
A series of prototypes that explore different written
approaches to conveying prescription drug information to consumers; and
A list of FDA speakers, invited workshop participants, and
meeting registrants.
This public workshop is intended to explore potential approaches
that will result in written prescription drug information that is
comprehensible, accurate, and more easily accessible to consumers. The
purpose of this public workshop is to assemble stakeholder groups to
determine appropriate steps towards improving the content, format,
distribution, and evaluation of patient information.
Registration: To register for the meeting either: (1) Mail your
registration information to one of the contact persons (see FOR FURTHER
INFORMATION CONTACT) or (2) e-mail your registration information to
PatientInfoPublicWkshp@fda.hhs.gov. Registration information should
include registrant name, company or organization, address, phone
number, and e-address. Registration requests should be received by
August 17, 2009. Registration is free. Seats are limited. FDA may limit
the numbers of participants from each organization based on space
limitations. Registrants will receive confirmation once they have been
accepted for participation in the workshop. Onsite registration on the
day of the meeting will be based on space availability on the day of
the event starting at 7:30 a.m. If registration reaches maximum
capacity, FDA will post a notice closing meeting registration for the
workshop at http://www.fda.gov/Drugs/NewsEvents/ucm168106.htm. If you
need special accommodations due to a disability, please contact Mary
Gross or Marsha Holloman (see FOR FURTHER INFORMATION CONTACT) at least
7 days in advance.
Dated:July 2, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-16335 Filed 7-9-09; 8:45 am]
BILLING CODE 4160-01-S