Senators announce agreement on plan to improve access to generic drugs

Thursday, June 5th 2003, 12:00 am

By: News On 6

WASHINGTON (AP) -- A bipartisan group of senators said Thursday that their plan to improve access to generic drugs could save billions of dollars and might be the best bet this year, as Congress struggles with the larger issue of providing a prescription drug benefit for seniors.

Sen. Judd Gregg, R-N.H., chairman of the Senate health committee, said the agreement reached after five years of negotiation "makes more prescription drugs available more quickly to more people at a lower cost with fewer lawyers involved and with more incentive for innovation."

Gregg said his committee will vote on the legislation next week. It is co-sponsored by Sen. Edward Kennedy, D-Mass., the panel's top Democrat, and Sens. Charles Schumer, D-N.Y., and John McCain, R-Ariz.

The bill would limit some of the practices brand-name pharmaceutical companies use to keep generic competitors off the market. It would allow only one 30-month stay, delaying Food and Drug Administration approval of a generic drug when a brand-name company sues the generic maker over patent infringement. Currently the brand-name company can use repeat 30-month stays to keep a generic off the shelves.

The first maker of a generic product to come to market now has 180 days of exclusivity, leading to abuses where the brand-name maker pays its competitor not to enter the market. The Gregg-Schumer bill would forfeit exclusivity for companies that enter anticompetitive deals or fail to come to market in a timely fashion.

The bill would also allow the generic company to file a counterclaim when sued by a brand-name firm.

The Senate passed a similar bill last year by a strong 78-21 vote, but Gregg voted against that legislation because he said it would lead to more lawsuits. The measure stalled in the House, opposed by Republican leaders, the White House and the drug industry.

Gregg said this year's version resolved his concerns over lawsuits and said the administration "feels fairly positive about this." He said the bill could be considered separately or as part of a larger Medicare prescription drug bill now under negotiation.

Schumer and Gregg said the bill could save consumers and the government around $60 billion over 10 years. An analysis of last year's bill found that such savings would come from reducing challenges and other delays keeping cheaper generic drugs off the market. It said the federal government would receive about 10 percent of those savings.

"It's a market-based approach that doesn't cost the government a penny and gives the drug industry a desperately needed dose of competition," Schumer said.

Bruce Lott, spokesman for the Pharmaceutical Research and Manufacturers of America, said: "We believe that the current law works well for patients, but we are reviewing Chairman Gregg's proposal."

Kathleen Jaeger, president of the Generic Pharmaceutical Association, said the compromise bill was "a very promising development" in the effort to provide access to cheaper drugs. "It really does put pressure on the House to answer the American public."

Last year, Reps. Sherrod Brown, D-Ohio, and Jo Ann Emerson, R-Mo., proposed similar generic drug legislation. Brown's office said he intends to introduce another bill after working with the Senate.

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