[Congressional Record Volume 145, Number 74 (Thursday, May 20, 1999)]
[Senate]
[Page S5757]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      BY MR. CRAPO:
  S. 1092. A bill to amend the Federal Food, Drug, and Cosmetic Act 
with respect to regulation of pharmacists, and for other purposes; to 
the Committee on Health, Education, Labor, and Pensions.


              PHARMACIST'S PATIENT PROTECTION ACT OF 1999

 Mr. CRAPO. Mr. President. I rise today to introduce the 
``Pharmacist's Patient Protection Act of 1999.'' The purpose of the 
legislation is to stop the implementation of final regulations that 
have been issued by the Food and Drug Administration that will require 
community pharmacists to provide agency sanctioned information when 
certain prescription drugs are dispensed to a patient. Such 
regulations, commonly called ``MedGuides'', were issued in final form 
on December 1, 1998.
  Now why would Congress want to prohibit a regulation which would give 
patients written information about their medications? The answer is 
very simple. During the 104th Congress, the House and Senate debated 
this very same issue, and ultimately a compromise was reached whereby 
FDA agreed not to promulgate its MedGuide regulations for a period of 
time so that the private sector would have the opportunity to work with 
the Administration to develop a voluntary action plan to continue to 
increase the quality and quantity of written information already being 
provided to consumers with prescription medication. Under the agreement 
which was enacted into law as part of the FY 97 Agriculture 
Appropriations, FDA is prohibited from implementing any part of the 
MedGuide regulations until the year 2001. When we get to the year 2001, 
FDA would be permitted to move forward with the MedGuide initiative 
only if voluntary efforts failed to get written information to 75 
percent of all patients receiving a new prescription.
  Regrettably, FDA has chosen not to live up to its part of the 
agreement. The agency's final rule to require Medication Guides for 
selected prescription drugs, which will take effect on June 1, 1999, is 
in clear violation of federal law. It appears that FDA is deliberately 
ignoring the law. It would be my hope that the Administration would 
hold in abeyance the implementation of the MedGuide regulations, and 
honor the remainder of the moratorium relating to this rule making. 
However, I am not confident that this will occur, and therefore this 
bill is necessary so that we can put back into place the terms of the 
agreement that were made with the Administration during the 104th 
Congress.
  Finally, I should point out that holding off the implementation of 
the MedGuide rule will not deny patients access to prescription drug 
information, nor will it preclude FDA from communicating with 
pharmaceutical companies and community pharmacists about the importance 
of providing information to patients about their prescription drugs. In 
other words, nothing in this bill should be construed as restricting 
the ability of the FDA to use its existing authority regarding the 
provision of written patient information on a product-by-product basis 
with certain prescription medications.
  Let the competitive retail pharmacy marketplace continue to make 
great strides in providing consumers with meaningful, accurate and 
easily understood written information about prescription drugs. I urge 
my colleagues to co-sponsor the ``Pharmacist's Patient Protection Act 
of 1999.''
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