Drug Importation Amendment Rendered Impotent

Yesterday, the Senate attached by a voice vote a drug importation amendment to the PDUFA reauthorization/FDA reform bill moving through the chamber. However, the amendment passed with its own amendment (called a second-degree amendment) which requires the Department of Health and Human Services to certify the safety and cost-effectiveness of all imported drugs. The FDA does not have the resources to assure the safety of all domestic drugs, let alone imported ones. Therefore, the second-degree amendment renders the drug importation amendment impotent. Nonetheless, the second-degree amendment passed 49-40, with 33 misguided Republicans, 15 wayward Democrats, and Sen. Joe Lieberman voting in the affirmative. (Here's the roll call.) Proponents of second-degree amendment raised safety concerns about drugs coming into the U.S. from Canada or the E.U. But this argument is specious. The drugs being imported are manufactured by American companies and are subject to strict safety tests in the exporting country. It is unclear what this amendment will mean for the fate of the overall bill. President Bush has vowed to veto a bill containing a drug importation provision. However, since this provision is mere rhetoric, the bill may now be more palatable to the White House. A final vote on the Senate bill is expected this week.
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