Lobbyists focus on safety in debate over generic drugs

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generic drugsWASHINGTON -- Biotechnology lobbyists attempting to slow the development of cheap generic versions of the world's most expensive drugs have been emphasizing questions about their safety in an effort to win support among the new Democratic leaders of Congress.

James C. Greenwood , a former congressman who is president of the Biotechnology Industry Organization , began raising qualms about drug safety with former colleagues on Capitol Hill even as the lawmakers were enlisting cosponsors for legislation to create a speedy mechanism for so-called biogenerics to reach the market.

"We think safety needs to be the primary concern. We think that in order to assure safety, you have to bring a full complement of data with the follow-on product," Greenwood told the Globe in a recent interview.

Greenwood's organization would like regulators to require that anyone developing a generic successor to a biologic therapy meet the same rigorous standards of research and testing as the drug's creator -- slowing rather than expediting generic biologics' arrival to market.

"Unlike a pharmaceutical product, where you can simply demonstrate that you have the same chemical formula and you don't need the clinical data, a follow-on biologic is a very, very different process," he said.

Bruce L. Downey , Generic Pharmaceutical Association board chairman, countered that safety concerns could be addressed without slowing the biogenerics bill.

"I don't want unsafe products on the market, either," said Downey, Barr Pharmaceuticals Inc.'s chief executive. "It is something we need to account for in how the regulatory process gets established. But it's not something that should delay the legislation."

Senator Michael B. Enzi, the current chairman of the Senate Health Education Labor and Pensions committee, said he has been approached by lobbyists representing branded and generic manufacturers.

"I just hope there is some way we can work through the maze, said Enzi, Republican of Wyoming. "Nothing's resolved."

Senator Edward M. Kennedy , Democrat of Massachusetts, who is expected to become chairman in January, promises to quickly hold hearings on the proposal to expedite the delivery of generic biologics to market, which could benefit some of the state's businesses, but could curb revenue for such biotechnology powerhouses as Biogen Idec.

"Massachusetts is an innovation economy, and Congress should support innovation," Kennedy said. "We must also act so that patients can afford the healthcare and breakthrough new medicines they need."

Senator Orrin Hatch , Republican of Utah, wondered at a recent hearing about a more measured approach to Food and Drug Administration approval of generic versions of biologic therapies based on living organisms, such as insulin and human growth hormone. Hatch had earlier supported landmark legislation that speeds to market chemical equivalents of branded products.

At the same hearing, Senator Hillary Rodham Clinton , a cosponsor of the generic biologic legislation, acknowledged the need to pay heed to the drug-safety challenge. Clinton said that message was hammered home during her recent visit to a Bristol-Myers Squibb Co. plant in New York.

The New York Democrat promised the bill would be a major focus for Democrats in 2007. She and Kennedy will get an assist on the Senate Health Education Labor and Pensions committee from Senator Barack Obama , who joins the panel in January and is skeptical about the branded industry's message.

"The barriers presented to generics entering the market have more to do with companies wanting to maintain the high profits they make on brand names than it does on safety issues," said Obama, Democrat of Illinois.

source The New York Times