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July 10, 2003

PRESCRIPTION DRUG REIMPORTATION:
ACCESS VERSUS SAFETY

Dear Democratic Colleague:

As we address the issue of allowing reimportation of prescription pharmaceuticals, I urge you to consider the issue of safety. It is not merely a makeweight matter trotted out as part of this debate -- it is a legitimate issue that all must confront. To that end, please review the attached Committee on Energy and Commerce staff memorandum outlining one example of the Food and Drug Administration’s lack of enforcement of existing drug safety laws. (The accompanying photos can be viewed at the Committee’s Minority website.)

The Gutknecht legislation may be viewed by some as sufficiently safe, or at least safer than the present "anything goes" non-enforcement mentality. It is not. H.R. 2427 would greatly expand the amount of importation, as well as loosen or eliminate important regulatory safeguards:

  • H.R. 2427 permits commercial shipments to pharmacists and wholesalers as well as imports for personal use, vastly expanding the quantities being brought in under relaxed standards;
  • H.R. 2427 lacks a prescription requirement or limits on individual quantities, thus eliminating doctors from drug therapy determinations and further opening the floodgates;
  • H.R. 2427 lacks authority for the Secretary to put in place adequate safeguards, including documentation, labeling, suspension authority against importers of counterfeits, and authority to prevent importation from countries with weak regulatory schemes; and
  • H.R. 2427 lacks the requirement for the Secretary to certify that implementation will not result in increased risk.

Of course, there are real health concerns caused by the inability to afford needed prescription drugs. Not taking needed medicine is neither safe nor effective. So I understand the desires of many to substitute the risks of reimportation for the risks of unaffordable drugs. I cannot agree; I oppose the Gutknecht bill.

But the problem addressed by the Gutknecht bill -- high drug prices -- remains. More needs to be done to make prescription drugs more affordable. In particular, the House Republican Medicare bill is wholly deficient in providing our seniors reasonable access to affordable drugs. And the gross and unfair disparity between drug prices here and abroad continues. So the current avalanche of foreign drugs into the U.S. from suspect sources will worsen. We must continue our fight for the ability of Medicare to negotiate drug prices on behalf of seniors, for the increased availability of generic drugs for all, and for other measures that address the high cost of prescription drugs without risking safety.

Sincerely,


JOHN D. DINGELL
RANKING MEMBER

Attachment

Prepared by the Committee on Energy and Commerce
2125 Rayburn House Office Building, Washington, DC 20515