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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2009-N-0295]

# 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                               ( print 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 (§ 310.501 (21 CFR 310.501) and § 310.515 ( 21 CFR 310.515)). PPIs for estrogens (§ 310.515) and oral contraceptives (§ 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.                          ( print 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]

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