CQ TODAY – HEALTH
Drug Importation Provision Neutralized in Senate FDA Overhaul Measure

Opponents of a Senate proposal to allow the importation of prescription drugs claimed a surprisingly wide victory Monday, adopting an amendment that foiled the intent of a provision by North Dakota Democrat Byron L. Dorgan.

The Senate adopted, 49-40, a second- degree amendment by Thad Cochran, R-Miss., that would require the Health and Human Services Department to certify the safety and cost savings of any drug imports.

The Bush administration has said it cannot do that, so the effect of Dorgan’s drug importation language, subsequently adopted by voice vote, was rendered moot.

The decision played out as part of the Senate debate on legislation (S 1082) that would overhaul the Food and Drug Administration’s (FDA) prescription drug user-fee system.

The Senate also voted, 82-8, to cut off debate on the substitute amendment to the measure. But, despite some optimism expressed early in the day that the bill might speed to passage after the drug importation debate was settled, other points of contention remain, and the debate will resume Tuesday.

The Cochran amendment split both parties, with 15 Democrats and one independent joining 33 Republicans in voting for the amendment. Voting “no” were 28 Democrats, 11 Republicans and one independent.

Up until the vote, the outcome appeared to be in doubt. Vice President Dick Cheney was on hand in case he was needed to cast a tie-breaking vote. Dorgan and Debbie Stabenow, D-Mich., worked the room in an effort to persuade lawmakers to defeat the Cochran amendment.

They claimed one victory: Jeff Bingaman, D-N.M., switched his vote to “no,” but it was not nearly enough.

Edward M. Kennedy, D-Mass., the bill’s manager, said the substitute amendment addressed the concerns of a number of members on his side of the aisle.

But some members still have ideas about ways to change the bill.

Kansas Republican Pat Roberts wants to strip the bill’s controls over direct-to-consumer drug advertising.

“If the bill were to pass in its current form, we would have a situation where the secretary — at his discretion — is mandating certain warning requirements for all advertisements,” Roberts said in a statement. He called such requirements a violation of the First Amendment and said that instead drug companies should pay fines for misleading ads.

The Senate is expected to finish work on the bill this week. The measure is considered must-pass legislation both by the pharmaceutical industry, which pays the fees to have its products reviewed by the FDA, and by the agency.

The House has yet to take up FDA overhaul legislation, but drug importation language is expected to get a more sympathetic hearing in that chamber.

Rep. Rahm Emanuel, D-Ill., has sponsored a companion measure (HR 380) to Dorgan’s proposal.

According to a House Democratic aide, the importation bill will get a vote either as a stand-alone bill or as an amendment to a House FDA overhaul bill.

Matthew Speiler contributed to this story.

First posted May 7, 2007 8:10 p.m.

Correction
Corrects to say Bingaman switched his vote to "no."
Source: CQ Today
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