HHS NEWS

P97-02                             Food and Drug Administration
FOR IMMEDIATE RELEASE              Donald McLearn
January 14, 1997
                                   Media Inquiries: 301-827-6242
                                   Consumer Inquiries: 1-888-INFO-FDA                                      
                   

            PRESCRIPTION INFORMATION PROGRAM LAUNCHED

     HHS Secretary Donna E. Shalala today launched a cooperative
public-private plan designed to provide consumers with better and
easy-to-read information about their prescription drugs.  The
plan is aimed at improving patient understanding of prescription
drugs and reducing the misuses of medications that currently lead
to thousands of hospitalizations each year. 
     Assisted by the Keystone Center, a nationally recognized,
non-profit public policy mediating organization, a 34-member
steering committee representing the pharmaceutical industry,
pharmacists, physicians, consumer and patient advocacy groups,
patient drug information data base companies and other interested
groups participated in developing the plan. 
     "Industry, consumers and government have cooperated to
produce a plan that will work for patients," Secretary Shalala
said. "Working together and using todayœs computer technology, we
can make prescription information more widely available, more
understandable and more relevant for each individual patient."
     Under the plan, useful drug information must reach 75
percent of patients by the year 2000 and virtually all patients
(95 percent) by 2006.  The "Action Plan for the Provision of
Useful Prescription Medicine Information" was delivered to
Secretary Shalala last month.
     In a letter to Keystone Vice President John R. Ehrmann,
released today, Shalala accepted the plan and set the new program
into action.
     HHS Assistant Secretary for Health Philip R. Lee, M.D., said
the plan "will help patients correctly adhere to medical regimens
and prevent inappropriate use of prescription drugs. 
Hospitalizations caused by improper use of prescription drugs
cost an estimated $20 billion per year."
     The action plan, which was developed by the representatives
of all involved parties, puts on track an effort that has long
been high on the public health agenda, said Dr. Lee, who chaired
the original HEW Task Force on Prescription Drugs from 1968 to
1969.
     FDA Commissioner David A. Kessler said: "When patients get
prescription drugs, they deserve the same kind of easy-to-read
and easy-to-understand information they get when buying a box of
cereal with the Food Label. That's what this is about."
     The plan, which was developed under a 1996 law, parallels
the requirements of a proposal made by FDA in 1995 for the
development and distribution of medication guides that are easily
understood, non-promotional in tone and content, and
scientifically accurate.  Following publication of the FDA
proposal, Congress directed the HHS Secretary to convene a
committee of diverse interest groups to develop a long-range,
comprehensive action plan to voluntarily improve oral and written
communication to patients about their prescription medicines.
     The plan fulfills the Congressional mandate by addressing
the following requirements:
œ encourage health care professionals to improve their
  communications with consumers about prescription medicines;
œ identify mechanisms and incentives to ensure voluntary efforts
  to meet the distribution targets for the years 2000 and 2006;
œ establish criteria for the development and distribution of
  written information with drug information for patients;
œ encourage activities to increase consumer understanding of the
  benefits of such information;
œœdevelop mechanisms for periodic evaluation of the voluntary
  program; and
œ promote consistency with relevant state board regulations.
     In two areas, the steering group presented the Secretary
with options rather than recommendations.   
     Responding in today's letter, Shalala said the information
provided to patients will cover all uses of the medication that
are approved by FDA, and in addition, physicians and pharmacists
will be able to provide any further needed information about
"off-label" uses as long as it is customized for each individual
patient.  Thus, information can be made available about uses that
generally lack the strong scientific base required for FDA
approval, but which are deemed appropriate by the prescriber or
dispenser. 
     In addition, the Secretary said she would continue to
evaluate progress made by the private sector in meeting the goals
of the plan, and would welcome similar monitoring efforts by
industry and consumer organizations. ####