# Drug Reimportation Bill Approved



## Mike NoLomotil (Jun 6, 2000)

Senate Approves Drug Reimportation BillList of How Senators Voted Is AttachedThe drug industry took another hit yesterday as the Senate voted to approve a drug reimportation bill, allowing wholesalers and pharmacists to reimport into the U.S. FDA-approved drugs that sell for much lower prices abroad. While it is no guarantee that the full cost savings would be passed on, it is likely that it could put downward pressure on U.S. prices. An amendment to the amendment was also approved that requires the Department of Health & Human Services to certify to Congress that reimportation "(1) pose no risk to the public's health and safety; and (2) result in a significant reduction in the cost of covered products to the American consumer." If HHS can't make this certification the reimportation amendment would be voided. We are not sure whether HHS can make these assurances. Moreover, the appropriations bill does not provide the tens of millions of dollars that would be needed to conduct the reviews to make sure that products are not counterfeit or have not been tampered with. All of this is to be resolved in a House-Senate conference. The text of the Jeffords amendment is at: http://thomas.loc.gov/cgi-bin/query/D?r106...p/~r1066xJQAI:: Below is a summary of the issue from Congress Daily.---------------------------------------------Senate OKs Drug Reimportation Bill, But With A CatchAlthough a bill to loosen restrictions on the reimportation of FDA-approved prescription drugs passed the Senate Wednesday, 74-21, it was amended to include a high hurdle for the Clinton administration. The amendment would require the HHS to certify it poses no additional safety risks to public health. The amendment to the FY2001 Agriculture spending bill would allow pharmacists and drug wholesalers to import lower cost, FDA- approved prescription drugs from other countries. It also would allow the FDA to enforce safety laws but provides no additional funds for the agency to do so. "It would be very difficult to do [the certification] prospectively, and the secretary's ability to do so would depend on whether Congress provides the additional money necessary," said HHS Assistant Secretary for Legislation Richard Tarplin after the vote. Tarplin said that while the amendment has addressed the administration's safety concerns, its success will "hinge on whether the funds are provided." The administration's preliminary estimates suggest that tens of millions of dollars may be needed for the FDA to enforce the provisions of the amendment, although no new money is provided. The drug industry and opponents said it would raise serious safety concerns and undermine free trade. Opponents, such as Judiciary Chairman Hatch, warned against the measure, saying it could create a "gray market" of questionable drug imports and flatten efforts of U.S. drug companies to create new products and do research. "A fake Rolex may be right two times a day, but a fake drug could kill you," Hatch said. And some Democrats who supported the bill raised concerns that Republicans would use the vote as a way to avoid passing a prescription drug coverage bill this year. "Republicans who support this drug import amendment but vote against our proposal to cover prescription drugs under Medicare are guilty of the worst kind of hypocrisy," said Health, Education, Labor and Pensions ranking member Edward Kennedy, D-Mass. "This amendment may have a positive impact on drug prices, but it is no substitute for a meaningful Medicare benefit," he said. But HELP Chairman Jeffords, the chief sponsor of the amendment, dismissed that concern. He said after the vote the amendment was just a "shot across the bow. We've got to get the thinkers at the table to justify why Americans pay the highest prices." The amendment, Jeffords said in his statement, is about the equitable treatment of Americans, particularly those without health insurance. "As I have said before, this is not the only solution and may not be the best solution. I strongly believe that we need a prescription drug benefit in the Medicare system," he said. Sens. Byron Dorgan, D-N.D., Paul Wellstone, D-Minn., Slade Gorton, R-Wash., Tim Johnson, D-S.D., Carl Levin, D-Mich., and Richard Bryan, D-Nev., were cosponsors of the Jeffords' amendment. The second degree amendment, which requires HHS to certify that there would be no new safety risk under the Jeffords amendment, was sponsored by Agriculture Appropriations Subcommittee Chairman Thad Cochran, R-Miss., and Sen. Herb Kohl, D-Wis. The amendment passed 96-0. -- By April Fulton _______________________________________________


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