[Congressional Record Volume 142, Number 49 (Wednesday, April 17, 1996)]
[Extensions of Remarks]
[Pages E558-E559]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




              PHARMACIST'S PATIENTS PROTECTION ACT OF 1996

                                 ______


                         HON. MICHAEL D. CRAPO

                                of idaho

                    in the house of representatives

                       Wednesday, April 17, 1996

  Mr. CRAPO. Mr. Speaker, I rise today to introduce the Pharmacist's 
Patients Protection Act of 1996. This legislation relates to an 
everyday common occurrence, namely getting a prescription filled at 
your local pharmacy. As we all know, when you go to your pharmacy for a 
prescription, the pharmacist not only offers to counsel you on how to 
take your medication safely and effectively, but the pharmacist also 
provides detailed written information that is understandable and user 
friendly when the prescription is dispensed.
  Through the use of computer technology, consumers routinely receive 
written information about prescription drugs from their pharmacist in a 
variety of retail settings, such as pharmacies located in supermarkets, 
chain drug stores and independent pharmacies. And not only are 
pharmacists providing the information voluntarily, more importantly 
this written information is often specifically tailored to the 
particular needs of the patient in order to achieve the maximum benefit 
from the prescribed medication.
  I applaud community pharmacists for their dedication and commitment 
in this important area of patient education and information, but 
apparently these voluntary efforts aren't good enough for the Food and 
Drug Administration. Even though every survey conducted since 1994 
shows that patients routinely receive written information on both new 
prescriptions

[[Page E559]]

and refills, FDA has decided that it wants to mandate this aspect of 
pharmacy practice and to restrict pharmacists so that only the 
information that FDA deems appropriate is distributed to patients.

  In other words, FDA knows better than your personal physician and 
your pharmacist regarding the information you should receive. And on 
top of this, FDA wants everybody to get the same information, no matter 
whether you are elderly, a young child, male, female or pregnant.
  The cost of this particular FDA initiative, called the Medguide 
Program will exceed $100 million each year to mandate what pharmacists 
are already doing voluntarily right now. FDA's Medguide Program is 
unnecessary, very costly and is the wrong approach.
  Additionally, I should mention that FDA's Medguide Program exceeds 
the agency's statutory authority. While FDA does have legal authority 
over the content of a drug manufacturer's labeling and advertising, FDA 
has no authority whatsoever over the professional practice of pharmacy. 
Standards of professional practice, including patient care, counseling 
and the dissemination of written information to patients has always 
been and still are the responsibility of state boards of pharmacy--not 
FDA.
  In summary, Mr. Speaker, the legislation I am introducing will 
prohibit the FDA from using any of its funding to implement its 
proposed Medguide Program.
  We don't need this costly mandate from the FDA when the competitive 
retail pharmacy marketplace is making great strides in providing 
consumers with meaningful, accurate and easily understood written 
information about prescription drugs. I urge my colleagues to cosponsor 
and support the Pharmacist's Patients Protection Act of 1996. Let's 
stop the misguides Medguide Program.

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