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GOP Spars Over Drug Import Bill

Some Senators Aim to Regulate Purchases; Others Aim to Block

By Ceci Connolly
Washington Post Staff Writer
Wednesday, April 20, 2005; Page A23

Behind-the-scenes Republican Party divisions over whether to allow Americans to import lower-priced medications from such countries as Canada exploded yesterday in an unusually public and personal exchange between two New England lawmakers.

At a contentious hearing, Sens. Judd Gregg (R-N.H.) and Olympia J. Snowe (R-Maine) squared off over an issue that has increasingly put GOP leaders at odds with rank-and-file lawmakers and much of the public.

The bill would undo 100 years of drug safety regulation and replace it with a questionable new system "Hinging on the term 'manufacturing changes.'" -- Sen. Judd Gregg (R-N.H.) (Dennis Cook -- AP)

Snowe, accompanied by a bipartisan group of senators, came to promote a bill creating a regulatory system enabling U.S. pharmacies, wholesalers and consumers to buy cheaper prescription drugs from about 30 countries.

"The bottom line is we assure that a legitimate prescription and a qualified pharmacist will be vital ingredients in assuring safety," she said.

Gregg, former chairman of the Senate Health, Education, Labor and Pensions Committee, did not mention his own competing bill but lashed out at Snowe and the others for "creating a Russian roulette regime in the name of politics."

He said the bill would undo 100 years of drug safety regulation and replace it with a questionable new system "hinging on the term 'manufacturing changes.' " With his voice rising, he repeatedly pressed Snowe to explain the term.

Seated at a table facing Gregg and the other committee members, Snowe held her ground. "We send men and women up to space every day, and we can't figure this out?" she asked.

Back and forth the two parried, Gregg's face growing a deep pink as Snowe tried unsuccessfully to respond. With health committee chairman Mike Enzi (R-Wyo.) looking on in silence, Gregg told Snowe he would not share his limited speaking time with her if she did not answer the question.

"I am answering your question," she said. "You don't like the answer."

For more than a decade, individual patients have traveled to Canada, Mexico and Europe to purchase prescription drugs at 50 to 70 percent less than the U.S. cost. Legislative proposals to legalize that practice, first introduced in 1999, have gained votes as public uproar over drug prices has grown.

The Bush administration and Senate Majority Leader Bill Frist (R-Tenn.) have blocked action on import legislation, even as 77 percent of Americans surveyed in a poll released yesterday said they support changing the law.

David A. Kessler, who as commissioner of the Food and Drug Administration had reservations about opening the borders, told the panel that Congress must develop a safe importation system.

"The choice before you is not the choice of imports or no imports," said Kessler, now vice chancellor of medical affairs and dean of the School of Medicine at the University of California at San Francisco. "We already have a system of importation of drugs that jeopardizes public health."

Describing the current unregulated system as "out of control," Kessler noted that about 10 million prescriptions were shipped from Canada into the United States in 2004.

Kessler praised several safety measures in the bill. The legislation would pertain only to FDA-approved medications made in FDA-inspected plants. U.S. pharmacies and wholesale distributors would be required to register with the FDA and to produce "chain of custody" paperwork that documents the source of the drug and its path to the consumer.

"American citizens who choose to buy their drugs from another country or via the Internet will have confidence they are getting drugs that are indeed safe and effective," Kessler said.

Pharmaceutical industry representatives did not testify at the hearing but have raised several objections in the past, including concerns over possible counterfeiting or tampering with imported drugs and reduced revenue to support research and development.

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