Washington Editor

WASHINGTON - Senate Democrats have biotechnology and pharmaceutical lobbyists scrambling to preserve all elements of the 18-year-old law that created the generic drug industry.

Instead of debating Medicare legislation to provide prescription drug coverage for the elderly in the last few months before the mid-term elections, the Senate is looking at poking holes in the Hatch-Waxman Act of 1984.

"There has been an unrelenting, distorted and steady drumbeat of criticism aimed at the research-based pharmaceutical and biotechnology industry for the last several months - and now it has taken its toll," Jeff Trewhitt, spokesman for the Washington-based Pharmaceutical Research and Manufacturers of America, told BioWorld Today.

Indeed, the issue at hand relates to a bill (S.812) introduced several months ago by sens. John McCain (R-Ariz.) and Chuck Schumer (D-N.Y.) that reforms Hatch-Waxman by closing loopholes that have allowed the drug industry to extend patents. The Hatch-Waxman Act does not cover biologics. (See BioWorld Today, April 29, 2002.)

"The Democratic leadership has made a decision to take up a bill [McCain-Schumer/Edwards-Collins] that will do nothing to provide Medicare coverage, which is what seniors want and need," Sharon Cohen, vice president for government relations at the Washington-based Biotechnology Industry Organization (BIO), told BioWorld Today. "This is a diversion from the real issue. It also is a direct threat to the U.S. patent system. If we are hopeful that biotech companies will be able to innovate and create new treatments, this is the wrong way to go about it."

While the McCain-Schumer legislation has drawn criticism from the industry, an amendment, drafted by sens. John Edwards (D-N.C.) and Susan Collins (R-Maine), is creating more of a stir.

BIO's president, Carl Feldbaum, sent a letter to Sen. Edward Kennedy (D-Mass.), chairman of the Health, Education, Labor and Pensions Committee, detailing criticism of the legislation and its amendment, both considered a severe threat to the industry.

According to the letter, Edwards-Collins would "completely abolish patent rights if litigation is not initiated within 45 days of notice by a generic that it intends to challenge a patent, or if a new drug applicant failed to list its patent with the FDA within 30 days."

Furthermore, Feldbaum's statement says, the legislation would "selectively codify certain regulations governing bioequivalence requirements and would legislatively shield the FDA from challenges to its actions in setting approval standards." (Bioequivalence is the determinant of safety and efficacy of a generic drug.)

The proposed changes would make it impossible for drug manufacturers, whether pioneer or generic, or members of the public to challenge improper standards enacted by the agency on key approval criteria, or to challenge improper decisions made under valid authority, the letter said.

Trewhitt said the proposed legislation would "unravel the fine balance in the federal law between the two industries and it would tilt the balance toward the generic industry and make it extremely difficult for brand-name companies to defend patents. It is essential to have adequate patent protection at a time when companies are spending an average of $800 million to research and develop new drugs."

Kathleen Jaeger, president and CEO of the Washington-based Generic Pharmaceutical Association, released a prepared statement saying, "An unprecedented number of employers, insurers, unions and consumer groups have come together to support this effort to restore some of the balance to the Hatch-Waxman process.

"This landmark legislation addresses several loopholes that are exploited by some brand pharmaceutical companies to delay generic competition and keep the cost of important medicines unnecessarily high," Jaeger said.

Both Cohen and Trewhitt said a vote on the McCain-Schumer legislation with the Edwards-Collins amendment could come within weeks.

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