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Senators Optimistic About Passing Drug Importation Bill

The Democratic takeover of the Senate, coupled with the retirement of a once-powerful Congressional opponent, greatly improves the chances of Congress allowing prescription drug importation, lawmakers said today.

Sens. Byron Dorgan (D-N.D.) and Olympia Snowe (R-Maine) expressed confidence that they will be able to win Senate approval this year for their legislation that allows consumers to purchase imported drugs, pointing to both growing public support for the idea and the retirement of former Senate Majority Leader Bill Frist (R-Tenn.), who had been a major opponent of their proposal.

Dorgan and Snowe plan to move the Pharmaceutical Market Access and Drug Safety Act of 2007 (S.242) through the Senate Health, Education, Labor and Pensions Committee as quickly as possible, though Snowe said no date has been set for markup yet.

Their bill would allow individuals to directly order medications from outside the U.S. when using a Canadian pharmacy that is registered with and approved by the Food and Drug Administration. The FDA would examine, register and inspect these facilities on a regular basis. The legislation also would allow U.S. licensed pharmacists and wholesalers to import FDA-approved medications from a number of major industrialized nations and pass along their savings to customers.

In the House, an identically titled bill (H.R. 380) has been introduced by Rep. Rahm Emanuel (D-Ill.). Speaker Nancy Pelosi (D-Calif.) has committed to getting the House version of the bill to the floor “very soon,” an aide to Emanuel said.

Snowe, Dorgan and supporters such as the AARP believe that allowing drug importation significantly will lower drug costs for Americans. But the FDA and the drug industry oppose the bill, citing safety concerns in allowing importation.

Allowing importation will open the doors to counterfeit drugs, increasing the risk for American consumers, the agency and the Pharmaceutical Research and Manufacturers of America said. Importation “will circumvent a system that was carefully constructed and developed over the last century to protect the health and safety of the American public,” PhRMA’s CEO, former Rep. Bill Tauzin (R-La.), testified today at a hearing of the Senate Commerce, Science and Transportation subcommittee on interstate commerce, trade and tourism.

But lawmakers weren’t buying that argument. “Safety is not an issue, it’s just a distraction,” Sen. Jim DeMint (R-S.C.) said. The bill’s sponsors “have identified every conceivable problem regarding safety,” Snowe added. For instance, the bill provides for a registration system for importers and exporters and gives the agency the authority and the funding to inspect these facilities and their shipments.

Randall Lutter, the FDA’s acting deputy commissioner for policy, declined to comment on the bill, arguing that he had yet to see it, but added that for the agency to support importation of any kind, it would need to be limited to Canadian drugs, high-volume products where there is clear evidence of cost savings and drugs where there are no specialized handling requirements. Dorgan told Ludder he would be following up with the agency to get its views on the legislation by next week.

Dorgan, in an interview, called the Democrats’ Senate takeover an “earthquake” that fundamentally changed the prospects for the bill. It always has had bipartisan and public support, he said, but unlike in previous years, “Frist will not be able to put this bill in cold storage.”

Snowe agreed that the “dynamics have changed since the last election.”

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