Washington Editor

WASHINGTON - Medicare legislation poised for a vote in Congress contains language designed to get generics to market faster by closing loopholes in a law that has enabled certain innovator pharmaceutical companies to block generic competition.

The 10-year, $400 billion Bipartisan Medicare Plan stops innovator or brand-name companies from "stacking" multiple 30-month extensions on patents, which prevent generic companies from introducing their drugs to market.

While the drug industry believes instances of stacking are rare, many lawmakers and supporters of the generic industry have long argued that large brand-name companies have exploited that weakness and others in the Hatch-Waxman Act of 1984, the law that created the generic drug industry.

In a move to correct the situation while Congress debated Medicare, the Bush administration in August implemented an FDA rule that limits innovator companies to one 30-month patent extension. (The FDA rule would have to be in compliance with Medicare legislation passed by Congress and signed by the president.)

Pending Medicare legislation also would allow more than one generic company to qualify for 180-day market exclusivity if they file for approval on the same day, Reuters reported.

Rep. Billy Tauzin (R-La.), chairman of the House, Energy and Commerce Committee, issued a statement saying generic groups have endorsed the Medicare legislation.

"Medicare conferees have worked tirelessly to ensure that generic drugs reach the marketplace in a more timely fashion, and I am confident we have struck the right balance for both name-brand pharmaceutical companies and generic drug companies," Tauzin's statement said. "The language in the final Medicare bill closes the unintended loopholes of Hatch-Waxman and allows the American consumer to be the biggest winner by having speedier access to much-needed, cost-saving generic drugs."

Indeed, the Coalition for a Competitive Pharmaceutical Market (CCPM) released a statement calling on Congress to pass the legislation. The Washington-based organization said provisions agreed upon by the conference "are critical cost-containment measures [and] will provide much-needed relief to all American consumers, employers, insurers and others facing unsustainable, double-digit increases in prescription drug costs."

Under the Bipartisan Medicare Plan, an annual, up-front cash credit of $600 will be available to impoverished seniors to help them purchase pharmaceutical medications in 2004 and 2005. The cash credit will join the Prescription Drug Discount Card that will be available to all seniors in 2004 and 2005, regardless of income, according to the office of House speaker Dennis Hastert (R-Ill.).

The full prescription drug benefit will kick in by 2006. Low-income seniors (single people with income less than $12,900 a year and couples with less than $16,600) will purchase generics for $2 and name-brand prescriptions for $5, Hastert's office said.

As for the legislation in total, Carl Feldbaum, president of the Washington-based Biotechnology Industry Organization, told BioWorld Today the bill needs to be enacted. While it is not perfect, Feldbaum said, BIO's principles and objectives are largely accomplished in the legislation. And if it doesn't make it through this year, Feldbaum believes the timeline for new legislation would be late 2005 to 2006.

Votes in the House and Senate are expected to take place within days, as the session should be ending before the Thanksgiving holiday. Congress will remain on break until late January.

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