June 20, 2003

Senate Approves Drug Imports From Canada

Associated Press -

WASHINGTON (AP) -- The Senate voted Friday to allow U.S. pharmacists to buy prescription drugs in Canada, where the same medicines sell for less, and resell them here in another attempt to drive down the rising cost of drugs. But a crucial detail is likely to prevent it from ever becoming law.

The 62-28 vote attached the measure to the Medicare prescription drug bill moving through Congress, where approval in the House and Senate was expected by the end of next week.

Lawmakers, especially those living in states bordering Canada, have pressed for the change for years, spurred in particular by senior citizens in their states who board buses to cross the border and buy cheaper drugs.

But the measure also requires the secretary of health and human services to certify that the reimportation can be done safely. A similar law is already on the books, but former HHS Secretary Donna Shalala would not certify that it could be done without risk to patients. Her successor, Tommy Thompson, said the same.

And a letter this week from Food and Drug Administration Commissioner Mark McClellan makes clear there's been no change of heart. McClellan said the FDA cannot guarantee that drugs that travel outside U.S. borders are safe or effective.

That didn't stop the Senate from acting. Sen. Byron Dorgan, D-N.D., successfully argued that Canada's safety controls were just as reliable as those in the United States and U.S. consumers have nothing to fear from drugs bought from Canadian pharmacists.

"If you believe it's unfair that we pay the highest prices in the world for prescription drugs, then vote for my amendment," Dorgan said.

Dorgan said this year's bill is different from the existing law because it allows reimportation only from Canada, where the drug safety system is nearly identical to the U.S. system. Prices are lower there because the government controls them by law.

But McClellan said in his letter that it makes no difference. "FDA cannot guarantee the safety of Canadian drugs," he wrote to Sen. Thad Cochran, R-Miss.

Opponents argued that it poses a particular danger in today's age of bioterror threats.

"It opens a new door, a new opportunity, and it is a new threat to the security of the people of this country," Cochran said.

The vote followed approval a day earlier of another strategy to drive down prices, overwhelmingly endorsing a plan to bring generic medicines to the market more quickly, 94-1.

"This is a very good day for consumers," Sen. Charles Schumer, D-N.Y., said after the generic drug provision was added Thursday.

The generic drug provision essentially codifies regulations issued by the FDA last week to make it more difficult for brand-name companies to block generic competition.

The provision also is designed to penalize generic drug companies if they enter deals in which brand-name competitors pay them to delay bringing the lower-cost alternative to market.

Off the Senate floor, a block of conservatives was lobbying to boost support for private companies, and it appeared that lawmakers had brokered a compromise to satisfy them. Conservatives see private insurance as the future of Medicare in delivering both drugs and routine health care.

Fearful that seniors would stay away from new managed care options being created by the bill, they want to pay private companies more, hoping the benefits would be good enough to attract a significant number of the elderly.

In the House, the second of two committees approved its version of a Medicare bill Thursday, defeating a series of Democratic amendments aimed at sweetening the benefits and reshaping the program. Approval by the House Energy and Commerce Committee, on a near party-line 29-20 vote, sent the bill to the House floor for debate next week.

The $400 billion, 10-year Medicare plan would, for the first time, give all seniors federal subsidies to buy prescription drugs, relying principally on private companies to deliver the benefit. It also would create a new Medicare managed care option - preferred provider organizations - which supporters hope would give seniors more choice while saving the government money.

At issue, though, is how much money the government will have to pay PPOs to attract seniors. The Congressional Budget Office estimated that, as written, the bill would attract just 2 percent of seniors into PPOs, though other estimates put it higher.

At a stormy closed-door meeting Thursday, Republicans led by Sen. Jon Kyl of Arizona demanded more money for PPOs. They want payments to be based on competitive bidding by the insurance companies, not on the normal price of caring for a Medicare enrollee.

Senate Majority Leader Bill Frist, R-Tenn., said he was well aware of the tension and was trying to walk a careful line. "I'm going to do my best not to let it be an extreme bill to the left or to the right," he said.

Frist had $12 billion not yet allocated to help solve this problem and one other: how to keep employers from dropping coverage for their retirees once the Medicare benefit kicks in.

The controversy set off a series of daylong meetings involving key lawmakers and Thompson, officials said. At day's end, Frist said he hoped for a compromise that would give Kyl and conservatives their way, but only after a delay of four or five years. And he said Friday that compromise was still on track.

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