FDA may work with Democrats on generic biologics

WASHINGTON (Reuters) - Senator Chuck Schumer said on Wednesday that the head of the Food and Drug Administration had approached him about a plan to speed generic versions of pricey biotech drugs to the market.

FDA Commissioner Andrew von Eschenbach "came to my office last night and said: 'Let's work together on generic biologics.'" Schumer, a Democrat from New York, told the Reuters Regulation Summit.

Based on initial discussions, "we're not that far apart," he said.

The meeting came days after the Republican administration of President George W. Bush surprised many by calling for legislation enabling the FDA to approve generic versions of biotech medicines, also known as biologics, which are made from proteins from living cells.

Copycat versions could provide big cost savings for insurers and patients, some of whom pay thousands of dollars for branded biotech drugs, which are typically injected because they involve large proteins that are destroyed by the stomach.

The FDA was not available for comment.

Schumer, a co-sponsor of a bill in the U.S. Senate last year, said he might support the administration's call for industry user fees to help pay for the program.

He said the commissioner stopped by unannounced. "He came to me," Schumer said. "That really says something."

Generic companies such as Barr Pharmaceuticals BRL.N, Hospira Inc (HSP.N) and Teva Pharmaceutical Industries Ltd (TEVA.O) are pushing for the legislation the FDA says it needs to approve the drugs in the United States. Several other countries allow them.

Biotech companies had warned that biologics are too complex to copy, but recently have said they could support legislation creating an approval path.

Key areas of dispute include the amount of market exclusivity a brand name company gets and how much study a generic company would have to conduct for approval.

Schumer said it was too early to comment on those details.

(For summit blog: summitnotebook.reuters.com/)

(Additional reporting by Lisa Richwine; Editing by Lisa Von Ahn)