[Federal Register Volume 74, Number 131 (Friday, July 10, 2009)]
[Pages 33265-33267]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-16335]



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.


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.

Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6178, Silver Spring, MD 20993, 301-796-
3519, e-mail: [email protected]; 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: [email protected].


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 
    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 
     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 
    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 
[email protected]. 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]