05 June 2004

Senate battle looms over drug imports

A showdown is looming in the US Senate over prescription drug imports.

A Republican bill introduced this week to legalize imports takes a softer line against the US pharmaceutical industry than a competing, bipartisan bill, setting up a clash that will test the strength of importation advocates.

The expected confrontation hinges on the key difference between the tougher measure, backed by Democratic Senator Edward M. Kennedy of Massachusetts and Republican John McCain of Arizona, among others, and the bill introduced Wednesday by New Hampshire Republican Judd Gregg, chairman of the Senate committee for health care.

The Kennedy bipartisan proposal would prohibit drug manufacturers from using their most effective weapon against lower-priced imports: the ability to clamp down on wholesale supply to countries that ship drugs back to US consumers.

Gregg's bill contains no such prohibition. It would allow supply curbs imposed on Canadian wholesalers by Pfizer Inc., GlaxoSmithKline, and other drug makers to remain in place. Supporters of legalizing prescription imports say the Gregg legislation is intentionally weak -- that it might look good on the surface but would be ineffective.

"The Gregg bill is not aggressive enough to deal with the mischief that the pharmaceutical companies might do to Canada and other countries in terms of limiting their supplies," said Republican Representative Gil Gutknecht of Minnesota, a prime sponsor of importation legislation in the House, which passed a bill last year only to see it buried in the Senate.

"There are a whole lot of forces, including the pharmaceutical folks, that realize this train is just picking up too much momentum, and what they are trying to do is slow it down and divert it a bit," Gutknecht said in a telephone interview.

Gregg's office responded that the New Hampshire senator is dedicated to opening up a safe and legal channel for imports -- a concern raised by both the drug industry and Food and Drug Administration. But his office added that taking away the industry's power to limit wholesale supply could violate its constitutional rights to trade freely and hold patents.

"We have not found a way that we feel like it would pass constitutional muster," said Gayle Osterberg, a Gregg spokeswoman.

Osterberg said Gregg's proposal would allow Canadian pharmacies to "trans-ship," or ship drugs from other countries through Canada for the purpose of selling to US consumers. But David MacKay, executive director of the Canadian International Pharmacy Association, said trans-shipment is illegal under Canadian law. Without a prohibition on industry's supply tactics, said MacKay, Gregg's bill is "hollow. It has no legs."

Illegally importing prescription drugs from Canada, a country with government price controls, has grown to a $700 million-a-year business, fueled by the elderly and other US citizens with no prescription drug coverage. The FDA has not cracked down on individual consumers, though.

The election-year environment has given the issue fresh momentum, particularly since the launch of Medicare prescription discount cards, which have put the issue of the high cost of drugs in the spotlight. The cards, the first tangible benefit of the new Medicare drug benefit law, have been met with confusion and low enrollment.

Legalizing drug imports has attracted political support from both sides of the aisle in Congress. It is opposed by the GOP congressional leadership and the White House, but there have been signs of a softening. Senate aides said yesterday that there had not been negotiations for a compromise in the Senate. Senate Majority Leader Bill Frist has said he wants a bill to move forward, but has not discussed specifics or timing.

"He hasn't endorsed any specific bill yet," said Frist spokeswoman Amy Call. "He wants to talk with all the different senators and have a good healthy debate."

The Pharmaceutical Research and Manufacturers of America, the industry's Washington lobbying organization, calls Gregg's measure the "more responsible" option among what it considers multiple evils.

Meanwhile, the bipartisan group led by Kennedy, McCain, Democrat Byron Dorgan of North Dakota, and Republican Olympia Snowe of Maine is in the saber-rattling stage. The group says it plans to amend Gregg's bill on the floor if it comes out of Gregg's committee.

If there is no sign that Gregg's bill will reach the floor, sponsors plan to amend their bill to some other bill. Then the question will be if they have the 60 votes needed to pass it. The showdown could come as early as this month, because proponents want to force the issue before the November elections.

"As prices grow more outrageous every day, it's clear that Republicans can't stonewall the importation of cheaper prescription drugs much longer," Kennedy said in a statement. "I am increasingly hopeful that the Senate will pass drug importation by the end of the month."

By Christopher Rowland,
Boston Globe Staff  |  June 5, 2004

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