June 11, 2009 / 10:13 PM / 10 years ago

U.S. lawmakers tussle over generic biologic drugs

WASHINGTON (Reuters) - U.S. lawmakers tussled on Thursday over how long makers of biotechnology drugs should have an exclusive license for the expensive medicines in a hearing called to discuss a Federal Trade Commission report on the issue.

The FTC, which specializes in antitrust and consumer welfare, had concluded that passing a law allowing generic medicines for biotechnology drugs would create some savings for consumers but not the huge amounts that patients save by buying generic versions of some antibiotics and other, simpler drugs.

Democratic Representative Henry Waxman, who sponsored the original legislation creating generic drugs and is sponsoring a bill to allow five years of exclusivity for original biotech products, took issue with drug industry arguments for longer periods without competition.

“The drug industry has been engaged in a massive and expensive lobbying campaign to convince the members of this committee that the supply of life-saving drugs will dry up if they don’t get triple the monopoly protection available to all other drugs,” said Waxman, chairman of the Committee on Energy and Commerce.

He told the committee’s health subcommittee that he had seen “little or no persuasive evidence” to support industry claims that biotech companies need 12 to 14 years of exclusivity to break even.

Representative Anna Eshoo, a Democrat, disagreed and objected to the hearing for failing to bring scientific experts in to discuss the safety and effectiveness of the generics. “I’m puzzled and somewhat disappointed by the subcommittee’s approach,” said Eshoo, who was honored last July as the Biotechnology Industry Organization legislator of the year,

Biologic drugs — which are usually injectable — tend to be more complicated than traditional chemical medicines because they are made from living cells. Their generic versions will require a more complicated approval pathway than simpler chemical-based drugs.

Biologic medicines are used to treat everything from cancer to autoimmune diseases such as rheumatoid arthritis.

Representatives Marsha Blackburn, a Republican, and Tammy Baldwin, Democrat, expressed concern that the biotechnology companies in their districts would be unable to recoup the millions they invested in developing the complex drugs if generic versions came to market too soon.

“I will tell you I am very concerned about protecting the intellectual property of that industry,” said Blackburn.

Brand-name biotech companies such as Roche Holding’s Genentech Inc and Amgen Inc say they need an adequate period without competition to encourage development of new medicines.

The generic drug industry is eager to begin producing cheaper copies of the medicines.

The FTC report, which the pharmaceutical groups roundly criticized, concluded that competitors would likely enter the market only for drugs that had more than $250 million of annual sales, and only two to three generic entrants would be expected for each drug.

This means prices would likely drop just 10 to 30 percent while the first manufacturers would likely retain 70 to 90 percent of their market share, the FTC said.

Reporting by Diane Bartz; Editing by Steve Orlofsky

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