[Congressional Record (Bound Edition), Volume 146 (2000), Part 13]
[Senate]
[Pages 19355-19356]
[From the U.S. Government Publishing Office, www.gpo.gov]



                  REIMPORTATION OF PRESCRIPTION DRUGS

  Mr. DORGAN. Mr. President, in recent days we have heard a lot about 
various proposals that would allow for the reimportation of 
prescription drugs. Patients pay more for the prescription drugs in the 
United States than anywhere else in the world. That is just not right. 
The Senate passed a proposal that Senator Jeffords and I authored that 
would allow for the reimportation of prescription drugs as long as 
certain steps are taken to ensure safety for American consumers.
  I am pleased that the Administration and the Republican leaders in 
Congress have agreed to work together to take this common sense step 
towards making prescription drugs more affordable for everyone. Dr. 
David Kessler, former head of the FDA, has sent me a letter expressing 
his support for the Senate version of the reimportation language. Dr. 
Kessler agrees that we must reform the current system so that American 
consumers have access to safe and affordable medicine. At this time, I 
ask unanimous consent to have printed in the Record a letter from David 
Kessler for the Dorgan-Jeffords proposal in which he expresses support 
for our approach.
  There being no objection, the letter was ordered to be printed in the 
Record as follows:

                                               September 13, 2000.
     Hon. Byron Dorgan,
     719 Hart Senate Office Building,
     Washington, DC.
       Dear Senator Dorgan: Thank you very much for your letter of 
     Sept. 12, 2000. I very much applaud the effort that you and 
     your colleagues are making to assure that the American people 
     have access to the highest quality medicines. As you know, my 
     concerns about the re-importation of prescription drugs 
     center around the issues of assuring quality products. The 
     Senate Bill which allows only the importation of FDA approved 
     drugs, manufactured in approved FDA facilities, and for which 
     the chain of custody has been maintained, addresses my 
     fundamental concerns. The requirement that the importer 
     maintain a written record of the chain of custody and batch 
     testing to assure the product is both authentic and 
     unadulterated provides an important safety net for consumers.

[[Page 19356]]

       Let me address your specific questions. First, I believe 
     U.S. licensed pharmacists and wholesalers--who know how drugs 
     need to be stored and handled and who would be importing them 
     under the strict oversight of the FDA are well positioned to 
     safely import quality products rather than having American 
     consumers do this on their own. Second, if the FDA is given 
     the resources necessary to ensure that imported, FDA-approved 
     prescription drugs are the authentic product, made in an FDA-
     approved manufacturing facility, I believe the importation of 
     these produces could be done without causing a greater health 
     risk to American consumers that currently exists. Finally, as 
     a nation we have the best medical armamentarium in the world. 
     Over the years FDA and the Congress have worked hard to 
     assure that the American public has access to important 
     medicine as soon as possible. But developing life saving 
     medications doesn't do any good unless Americans can afford 
     to buy the drugs their doctors prescribe. The price of 
     prescription drugs poses a major public health challenge. 
     While we should do nothing that compromises the safety and 
     quality of our medicine it is important to take steps to make 
     prescription drugs more affordable.
       I applaud your efforts to provide American consumers with 
     both safe and affordable medicine.
           Sincerely,
     David A. Kessler, M.D.

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