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Senate Votes to Give Consumers Faster Access to Generic Drugs

 

By ROBERT PEAR and ROBIN TONER

New York Times, June 20, 2003

WASHINGTON - The Senate overwhelmingly approved a proposal yesterday to give consumers swifter access to low-cost copies of brand-name prescription drugs.

It also turned back a Democratic effort to limit the premiums that could be charged for new prescription drug benefits under Medicare.

The 94-to-1 vote on generic drugs came just minutes after the 56-to-39 vote on Medicare premiums.

Both proposals were offered as amendments to a sweeping bill that would add drug benefits to Medicare and fundamentally restructure the program, which provides health insurance to 40 million people who are elderly or disabled.

President Bush signaled his general support for the Senate bill today, but expressed several reservations.

In a formal statement of administration policy, the White House criticized an element of the bipartisan compromise at the heart of the Senate bill: a provision authorizing the government to deliver drug benefits to the elderly in areas where private insurers do not offer such coverage.

"The `fallback' provisions are a government-run delivery system for prescription drugs which could lead to government pricing of individual drugs and government regulation of the availability of certain prescription drugs," the White House said. The administration said it would work with Congress to ensure that private plans participate.

The administration's statement reflected the continuing tension between Republicans who want to maximize the role of private insurers and Democrats who want to expand the role of government in delivering the new drug benefits.

Twenty-seven Republican senators, mostly conservatives, sent an open letter to the White House today expressing concerns about the legislation, the cost of which is officially estimated at $400 billion over 10 years.

Though acknowledging that the Senate was likely to pass the bill, the group demanded changes to inject competition into Medicare. "We must move away from a Medicare-style price control structure that stifles quality and innovation, not impose these old ideas on an expanded and reformed system," they said.

The senators urged the administration to use its influence in later negotiations between the House and the Senate to increase Medicare's reliance on private insurers and the private marketplace.

Among those signing the letter were Senators Judd Gregg of New Hampshire, Rick Santorum of Pennsylvania, Trent Lott of Mississippi and Don Nickles of Oklahoma.

The senators also said any new Medicare law must "preserve, and not undermine, current employer-sponsored retiree health plans." The Congressional Budget Office says the Senate and House bills, by adding drug benefits to Medicare, would give employers a powerful incentive to curtail the drug coverage they now provide to retired workers.

Asked whether the Medicare bill was in trouble, Mr. Gregg said: "There are significant reservations on our side. But the momentum of the bill appears to be fairly strong."

The Senate majority leader, Bill Frist, Republican of Tennessee, said the bill was "still fluid." But he said he was "absolutely confident" that the Senate would pass it next week.

Supporters of the generic drug proposal said it would save money for people of all ages.

"Pharmaceuticals will be more readily available at lower prices for all Americans," said Mr. Gregg, who drafted the proposal with Senator Charles E. Schumer, Democrat of New York.

House Republican leaders have shown little interest in such generic drug legislation. But Mr. Schumer said it would be difficult for them to kill the proposal in the expected conference committee to iron out differences on the overall Medicare bill.

Mr. Schumer said the generic drug proposal could save consumers $60 billion to $70 billion in the next decade and could reduce Medicare costs by $18 billion to $20 billion. The proposal goes beyond new rules issued last week by the Food and Drug Administration, which took its own action to make generic drugs more accessible. In recent years, Mr. Schumer said, brand-name drug companies have used "frivolous patents, lawsuits and legal mumbo-jumbo" to delay the marketing of generic drugs.

The Gregg-Schumer proposal would limit the ability of brand-name drug companies to delay federal approval of competing generic drugs. Brand-name manufacturers would be allowed only a single 30-month stay, while a court tries to resolve patent disputes. Brand-name companies have sometimes blocked competition for much longer, by filing additional patent claims and piling 30-month stays on top of one another.

The measure would also bar collusive agreements under which brand-name drug companies pay generic companies to keep generic drugs off the market.

The existing law provides an incentive for generic drug companies to challenge patents that may be invalid. If they are successful, such companies have the exclusive right to market the generic drug for 180 days, but sometimes the drug never reaches the market. Under the Gregg-Schumer proposal, generic drug companies would have to market the drug in a timely way or lose their 180-day protection.

The other major vote today involved the monthly premium that would be charged for the new drug coverage. Sponsors of the Medicare bill say those premiums would average $35 a month, but the bill allows private plans to charge more, with federal approval.

The Senate Democratic leader, Tom Daschle of South Dakota, offered the amendment to limit premiums, by stipulating that they could not exceed the national average premium by more than 10 percent. Mr. Daschle said he was concerned about "the unpredictability and volatility of premiums."

But Senator Craig Thomas, Republican of Wyoming, said consumers would shun health plans that charged excessive premiums.


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