HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Wednesday, December 22, 2004

Drug Importation: HHS Report

Hhs The HHS Task Force on Drug Reimportation has issued its "Report on Prescription Drug Reimportation" (PDF).  Its findings are not terribly surprising:

  1. The current system of drug regulation in the U.S. has been very effective in protecting public safety, but is facing new threats. It should be modified only with great care to ensure continued high standards of safety and effectiveness of the U.S. drug supply.
  2. There are significant risks associated with the way individuals are currently
    importing drugs.
  3. It would be extraordinarily difficult and costly for “personal” importation to be
    implemented in a way that ensures the safety and effectiveness of the imported
  4. Overall national savings from legalized commercial importation will likely be a
    small percentage of total drug spending and developing and implementing such a program would incur significant costs and require significant additional authorities.
  5. The public expectation that most imported drugs are less expensive than American drugs is not generally true.
  6. Legalized importation will likely adversely affect the future development of
    new drugs for American consumers.
  7. The effects of legalized importation on intellectual property rights are uncertain
    but likely to be significant.
  8. Legalized importation raises liability concerns for consumers, manufacturers,
    distributors, pharmacies, and other entities.

Robert Pear has the story in the Wednesday N.Y. Times: "Administration Gives Mixed View on Drug Imports," with the following key points:

The Bush administration said Tuesday that commercial importation of some low-cost prescription drugs from Canada might be feasible. But the savings to consumers would be small, it said, and the federal government would have to spend hundreds of million dollars a year to ensure the drugs' safety.

The administration said in a report to Congress that legalizing imports would probably hurt the development of new drugs for Americans.

The report was released amid growing support for laws on importing drugs. Republican proponents include Senators Olympia J. Snowe of Maine, John McCain of Arizona and Trent Lott of Mississippi; Gov. Tim Pawlenty of Minnesota; and Representative Jo Ann Emerson of Missouri, as well as several newly elected members of Congress.

Sponsors of bills to legalize drug imports said they would keep pushing for it in the new Congress.

"I never had much confidence that this study was going to be objective," said the sponsor of one bill, Senator Byron L. Dorgan, Democrat of North Dakota.

Ms. Snowe said the administration had "failed to provide any meaningful recommendations" to Congress.

The conclusions of the report are generally consistent with studies by the drug industry, the Food and Drug Administration, and the Congressional Budget Office. Many economists and health care experts say importing drugs from countries that control their prices would do little to solve the problem of expensive drugs here.

On the other hand, consumer groups like AARP and some drugstore executives, including the chairman of CVS, have said commercial imports would be much safer than the current flood of largely unregulated imports by individuals.


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