[Federal Register Volume 61, Number 166 (Monday, August 26, 1996)]
[Notices]
[Pages 43769-43770]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-21942]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. 93N-0371]


Prescription Drug Information for Patients: Notice of Request for 
Collaboration to Develop an Action Plan

AGENCY: Department of Health and Human Services.

ACTION: Notice.

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SUMMARY: The Department of Health and Human Services (the Department) 
is requesting that national organizations which have an interest in 
providing prescription drug information to patients collaborate to 
develop a long-range action plan for distributing useful written 
prescription information to 75 percent of individuals receiving new 
prescriptions by the year 2000, and to 95 percent of individuals 
receiving new prescriptions by the year 2006. This document also 
describes the mechanism that the Department is instituting to 
facilitate collaboration among national organizations. This action is 
being taken under certain provisions of the Agriculture, Rural 
Development, Food and Drug Administration, and Related Agencies 
Appropriations Act, 1997.

DATES: Submit written requests for participation in this process by 
September 3, 1996.

ADDRESSES: Submission of notice of desire to participate should be 
addressed to: Keystone Center; 1001 G Street, NW., Suite 430 West, 
Washington, DC. 20001.

FOR FURTHER INFORMATION CONTACT:
Kevin S. Curtis, Keystone Center, 1001 G Street, NW., 430 West, 
Washington, DC., 20001, 202-783-0248 or via FAX 202-783-0328, or 
Internet [email protected]; or Betty Palsgrove, (HFY-40), Office of 
Health Affairs, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-1652, or via FAX 301-443-2446, or Internet 
E[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Under section 601 of the Agriculture, Rural Development, Food and 
Drug Administration, and Related Agencies Appropriations Act, 1997 
(Pub. L. 104-180) (The Appropriations Act), the Department is 
requesting the collaborative development and submission of an 
acceptable long-range, comprehensive action plan that will meet the 
goals for providing useful written prescription drug information to 
patients. This notice summarizes the Appropriations Act's requirements 
for the development and submission of the plan. It also describes a 
mechanism to facilitate development of a single unified plan.

A. Summary of the Appropriations Act

    The Appropriations Act directs the Secretary of Health and Human 
Services (the Secretary) to request that national organizations 
representing health care professionals, consumer organizations, 
voluntary health agencies, the pharmaceutical industry, drug 
wholesalers, patient information data base companies, and other 
relevant parties collaborate to develop a long-range, comprehensive 
action plan. The goals of this long-range, comprehensive action plan 
are the distribution of useful written information to 75 percent of 
individuals receiving new prescriptions by the year 2000, and to 95 
percent of individuals receiving new prescriptions by the year 2006.
    The Appropriations Act identifies six elements that must be part of 
this plan: (1) Goal identification, (2) assessment of the effectiveness 
of current private-sector approaches to providing oral and written 
information, (3) development of guidelines for providing effective oral 
and written information, (4) inclusion of elements necessary for the 
transmittal of useful information (scientifically accurate, 
nonpromotional in tone and content, sufficiently specific and 
comprehensive, and presented in an understandable and legible format 
readily comprehensible to product users), (5) development of a 
mechanism for periodic assessment of information quality and frequency 
of provision, and (6) provision for compliance with State Board 
regulations.
    If an acceptable long-range, comprehensive action plan is submitted 
to the Secretary not later than 120 days after the enactment of this 
Appropriations Act (i.e., by December 4, 1996), the Secretary will have 
no authority to implement FDA's proposed rule, Prescription Drug 
Product Labeling: Medication Guide Requirements (60 FR 44182, August 
24, 1995). The Secretary is to, in good faith and after due 
consideration, accept, reject, or suggest modifications to the plan 
within 30 days of the plan's submission. If the Secretary takes no 
action on the plan within 30 days of its submission, the submitted plan 
commences within 60 days of its submission. The Appropriations Act also 
states that the Secretary may confer with and assist private parties in 
the development of this plan.
    The Appropriations Act requires that, not later than January 1, 
2001, the Secretary is to review the status of the private sector 
initiative. If the specified goals are not achieved, the limitation on 
the Secretary's authority to implement the proposed rule would not 
apply. At that juncture, the Department would seek public comment on 
other initiatives that could be carried out to meet the previously 
stated goals.

B. The Collaborative Process

    The Appropriations Act specifies that the Department request a 
collaborative process to develop this plan, which would include a full 
range of representative national organizations. The Appropriations Act 
envisions the development of a single plan that would be submitted for 
review. However, the Appropriations Act does not specify a mechanism to 
ensure that a single plan be submitted, or how the Secretary should 
react if multiple plans are submitted. Thus, it is important to assure 
that a single unified plan representing the broad range of national 
organizations be submitted so that all parties interested in and 
responsible for the provision of patient information understand the 
goals and criteria for evaluating progress towards meeting these goals.
    Numerous national organizations representing health care 
professionals, consumer organizations, voluntary health agencies, the 
pharmaceutical industry, drug wholesalers, patient drug information 
data base companies, and other relevant parties have an interest in 
patient information. Many of these organizations have commented on 
FDA's proposed rule or attended conferences or meetings hosted by FDA 
and others to discuss this topic. However, no one single organization 
fully represents all of the interests, views, and capabilities of all 
the relevant organizations. Therefore, in order to assure a broad and 
balanced collaborative process and to aid in the

[[Page 43770]]

development of an acceptable, long-range, comprehensive action plan, 
the Department has asked the Keystone Center to serve as a facilitator 
to provide the organizational and logistical services and expertise for 
the development of this plan. The Keystone Center is a private, 
nonprofit public policy, science, and education organization that has 
broad experience in bringing together the diverse views of industry, 
consumer, and health professional groups. Additionally, the Department 
has asked the Keystone Center to form, in consultation with the 
Department, a steering committee that will solicit and coordinate input 
from all interested parties and oversee the development of the plan.
    The Department requests that all parties who represent national 
organizations and wish to participate on the steering committee, submit 
the following information to the Keystone Center (address above): (1) 
Name of individual and organization, (2) specification or certification 
that the organization is of national standing, (3) type of group 
represented (e.g., health care professionals, consumers, pharmaceutical 
manufacturers), (4) size of membership, (5) relevance of the 
organization to the plan goals or organizational interest in 
participation in development of the plan, and (6) address, e-mail, 
telephone number, and facsimile number of individual and alternate 
contact. Due to the shore timeframes specified in the Appropriations 
Act, this submission should be received [by] no later than 5 p.m. 
(EDT), September 3, 1996.
    The Keystone Center, in consultation with the Department, will 
select organization representatives from the submissions to become 
members of the steering committee. The committee will then solicit 
input from all interested parties and may hold a series of meetings to 
allow the parties to discuss and develop the plan. The first meeting of 
the steering committee will be hosted by the Department at a time and 
place to be announced. Invitations will be issued to the selected 
representatives. At this meeting, representatives from the Department 
and from the Keystone Center will discuss the development of an action 
plan and be available to answer questions.

    Dated: August 23, 1996.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 96-21942 Filed 8-23-96; 12:08 am]
BILLING CODE 4110-60-M