[Congressional Record Volume 149, Number 104 (Tuesday, July 15, 2003)]
[Extensions of Remarks]
[Page E1489]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




          REGARDING H.R. 2673 AND THE REIMPORTATION PROVISIONS

                               speech of

                                 ______
                                 

                           HON. JOHN SULLIVAN

                              of oklahoma

                    in the house of representatives

                         Monday, July 14, 2003

       The House in Committee of the Whole House on the State of 
     the Union had under consideration the bill, H.R. 2673:

  Mr. SULLIVAN. Mr. Chairman, H.R. 1, the Medicare Prescription Drug 
bill, which I supported, contains a provision which allowed for the 
importation of foreign medicines. However, it also included important 
safeguards that are not present in the importation provision included 
in this legislation. These new safeguards include: (1) Limiting 
reimportation to drugs being reimported from Canada; (2) requiring 
drugs reimported under its provisions to bear a statement designed to 
inform the patient that the drug was reimported by someone other than 
the manufacturer; (3) requiring the use of packaging that is reasonably 
certain to be tamper-resistant and not capable of counterfeiting; (4) 
preventing ``transshipment'' through third world countries by 
permitting the reimportation only of drugs that have not left the 
possession of the first Canadian recipient after receipt from the 
manufacturer; and (5) allowing the Secretary to designate one port of 
entry in the U.S.
  The provision included in the legislation before us allows 
reimportation from any country. Importing medicines from foreign 
countries weakens the U.S. pharmaceuticals distribution system by 
allowing the entry of pharmaceuticals from all over the world--even 
from countries with demonstrated counterfeiting problems. For example, 
this proposal would allow importation from South Africa, a country 
where ``Up to 20% of the medicines . . . are fakes or stolen and are 
almost impossible to distinguish from the real thing.''
  The provision included in H.R. 1 also requires imported drugs to say 
they are imported, the provision in this bill does not. Without proper 
labeling, patients won't know what drugs they are getting. Those of us 
who are not willing to take the risk with our health will have no way 
of knowing if they have purchased an imported prescription drug that is 
contaminated from their neighborhood pharmacy. Proper labeling gives 
Americans who choose not to use import prescription drugs the means to 
do so.
  This provision would also allow the transshipment of drugs, the 
provision included in Medicare Prescription Drug bill would not. 
Transshipment of prescription drugs from country to country provides no 
pedigree or record of where a particular prescription has been. Without 
a record of shipment, there is no guarantee of safety. H.R. 1 requires 
documentation, such as the origin, destination, and lot number assigned 
to the prescription drug that provides this safety.
  It also requires tamper resistant packaging, the provision in this 
bill does not. H.R. 1 requires prescription drugs from Canada be 
contained in packaging which the Secretary of Health and Human Services 
has ``determine[d] to be reasonably certain to be tamper-resistant and 
not capable of counterfeiting.'' Tamper-resistant packaging provides an 
extra layer of security to prescription drugs.
  Most importantly, the importation provision included in the Medicare 
Prescription Drug legislation contains language that allows the Health 
and Human Services Secretary to ensure the safety of the American drug 
supply and those drugs being imported, the provision included in the 
Agriculture Appropriations bill does not. The Medicare bill contains 
language that requires the Secretary of HHS to certify to the Congress 
that the new imports will (1) pose no additional health and safety 
risks, and (2) result in significant savings to consumers. This is 
important, since the safety and cost-savings provision was signed into 
law by Congress and President Clinton, as part of the ``Medicine Equity 
and Drug Safety Act of 2000,'' to ensure consumers are protected and 
that they save money. Since that time, two HHS Secretaries, one 
Democrat and one Republican, could not demonstrate cost-savings or 
safety from importation.
  The importation provision in the bill before us does not include any 
safeguards to ensure that the medicines patients receive are safe. I do 
not support taking this type of risk with the health of patients in my 
district. While I am voting in favor of H.R. 2673 because of numerous 
other provisions in the bill, I believe reimportation is poor policy 
and a serious safety concern to Americans.

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