Wednesday, April 20, 2005

Senators spar over imported drugs' safety

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WASHINGTON — Senators bickered over the safety of importing prescription drugs from abroad Tuesday, interrupting one another in a fierce debate over whether the promise of lower prices is worth the risk of counterfeit medication. A fiery exchange between Sen. Olympia Snowe, R-Maine, and Sen. Judd Gregg, R-N.H., illustrated the difficulty of winning congressional approval for importation.

Gregg accused Snowe of throwing away 100 years of federal law and regulation by proposing to allow importation from Canada and other countries.

"If you buy a pill, you want it to cure you, not kill you," Gregg said.

Snowe told Gregg he wasn't describing the bill accurately, saying it allows only importation of drugs approved by the Food and Drug Administration and manufactured at plants in other countries that the FDA has inspected.

Merely getting the hearing represented a victory for advocates of importation because of resistance from Republican congressional leaders and the drug industry. But the prospects for legislation being approved remain uncertain.

The Health Committee chairman, Sen. Michael Enzi, R-Wyo., scheduled the hearing under a personal commitment to advocates who have proposed legislation since 1999. But he cut off the exchange between Gregg, Snowe and Sen. Byron Dorgan, D-N.D.

"The purpose of a hearing is to gather as much information as possible, it doesn't all have to be said in the meeting," Enzi said.

Drug importation is a hot subject in Maine because poor and uninsured residents routinely travel to Canada to buy prescriptions at about half their cost in the United States. At the hearing, Dorgan held up identical bottles of Lipitor manufactured in Ireland - one cost $1.81 per pill in the United States and the other $1.01 per pill in Canada, he said.

"Why are U.S. consumers charged nearly double? What is the justification?" Dorgan asked.

The bill from Snowe and Dorgan would allow wholesalers and pharmacists to import drugs from Canada, Europe and other countries. The drugs must be approved by the Food and Drug Administration and come from manufacturing plants the agency regulates.

Importers would have to register with the FDA and they would be responsible for ensuring the safety of drugs and protecting against counterfeiting. The FDA would conduct random inspections; increased regulation would be funded with a 1 percent fee on all importations.

The drug industry, represented by Pharmaceutical Research and Manufacturers of America, didn't testify at the hearing. Instead, the group distributed highlights of a study that found drug-tracking paperwork can be easily forged and that technology to prevent counterfeiting easily overcome.

Russel Bantham, chief operative officer of the group, called the legislation a "bait-and-switch scheme."

"Americans do not want foreign medicine," he said. "They want affordable, high-quality medicine."

Snowe suggested that a country with the technology to send astronauts to the moon could surely prevent drug tampering.

Opponents of the legislation also argue that curbing drug prices could discourage research into new and innovative medication. But Snowe said drug research and development in the United States totals $32 billion, compared to $26 billion in Europe.

Dr. David Kessler, a former Food and Drug Administration commissioner testified that legalizing prescription-drug imports from Canada and elsewhere would make the practice safer for U.S. consumers.

Kessler headed the FDA under former President George H.W. Bush - President Bush's father - and President Clinton.

Sen. David Vitter, R-La., agreed. "Safety is a huge reason we should pass legislation like this," he said.

Washington Correspondent Bart Jansen can be contacted at 202-488-1119 or at:

bjansen@pressherald.com


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