Drug imports amendment passes, with strings attached

The Senate Monday approved language designed to permit the importation of less expensive medications from abroad, but not before attaching language opposed by supporters of “reimportation.”

Sen. Byron Dorgan’s (D-N.D.) amendment to a Food and Drug Administration (FDA) bill passed by voice vote Monday, following a 63–28 cloture vote on the language last Thursday. Dorgan’s legislation would allow individuals and wholesalers to import drugs from other countries for sale in the United States.

{mosads}But Dorgan and his allies were unable to beat back legislation sponsored by Sen. Thad Cochran (R-Miss.), which was favored by the Senate Republican leadership and the drug industry. Cochran’s measure would require the Department of Health and Human Services (HHS) to certify the safety of drugs brought in from abroad. The Cochran amendment passed 49–40.

The White House indicated last week that President Bush would veto any bill that contained reimportation provisions. The addition of the Cochran language, however, may free the president from rejecting the entire FDA bill. During both the current and Clinton administrations, HHS refused to guarantee that it could certify the safety of drugs imported from other countries.

Following the votes, senators were poised to vote on final passage of the underlying vehicle, which would reauthorize programs through which the pharmaceutical and medical device industries pay user fees to the FDA for reviews of their new products.