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Senate OKs Measure for Faster Access to Generic Drugs

The amendment to the Medicare bill would close loopholes used by brand-name makers.

June 20, 2003|Janet Hook, Times Staff Writer

WASHINGTON — The Senate on Thursday approved a long-stalled measure to make it easier to get cheaper generic prescription drugs to market, adding an important cost-control provision to legislation that would expand Medicare to cover pharmaceuticals.

The generic-drug measure, a compromise offered as an amendment to the Medicare bill, would close patent-law loopholes that allow brand-name drug manufacturers to protect themselves from competition by delaying the sale of generic equivalents.


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The agreement passed 94 to 1, capping years of debate over how to streamline the generic-drug approval process without crippling the incentives for brand-name companies to invest in the research needed to develop drugs. Both California senators voted in favor of passage; Sen. Orrin G. Hatch (R-Utah) was the only opponent.

"We want to make generic drugs more available to consumers on a faster time frame," said Sen. Judd Gregg (R-N.H.). "At the same time, we want to continue to encourage innovation in our brand-name companies."

The bill builds on rules issued last week by the Food and Drug Administration to speed the approval of generic drugs. That action stole some of Congress' thunder on legislation it has labored on for years. But between the FDA rules and the Senate legislation, proponents estimate, consumers would save more than $60 billion over 10 years as a result of increased availability of generic drugs.

The bill's prospects are uncertain in the House, where similar legislation died last year. Ken Johnson, spokesman for the House Committee on Energy and Commerce, said Republicans planned to put a generic-drug provision in their version of the Medicare bill, but it was unclear whether the provision would mirror Senate language.

Senate sponsors say the outlook for the bill is improved by changes made since last year, including limits on lawsuits by generic-drug companies that Republicans had sought. Gregg is one of several Republicans who opposed last year's Senate bill but now favors the compromise.

The generic-drug amendment was approved as the Senate continued debate on legislation to provide prescription-drug coverage for Medicare beneficiaries and to overhaul the health-care program to expand the role of the private sector.

Some have complained that the Medicare bill, although it provides new insurance for drug expenses, would do little to solve the related problem of soaring prescription drug costs. Those costs are expected to rise roughly 19% this year.

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