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DewDiligence

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Re: DewDiligence post# 51965

Thursday, 09/06/2007 5:37:03 PM

Thursday, September 06, 2007 5:37:03 PM

Post# of 253375
Lawmakers Say Generic Biologics Unlikely in FDA Bill

[The Senate is ready but the House evidently isn’t. I wouldn’t be surprised to see this become a significant issue in the 2008 elections.]

http://www.reuters.com/article/governmentFilingsNews/idUSN0636655520070906

>>
Thu Sep 6, 2007 2:54PM EDT
By Lisa Richwine and Kim Dixon

WASHINGTON, Sept 6 (Reuters) - Lawmakers are unlikely to add generic biologics legislation to a Food and Drug Administration bill expected to receive congressional approval this month, two key U.S. congressmen said on Thursday.

Generic drugmakers have been pushing legislation that would set a clear path for the FDA to approve cheaper copycat versions of biotechnology medicines.

The chances of adding the generic biologics measure to a broad FDA bill now moving through Congress are "extremely slim," Rep. Henry Waxman, a California Democrat, told a Generic Pharmaceutical Association conference.

The FDA legislation, which includes drug safety reforms and other measures, must pass by the end of September in order to maintain industry fees that help fund drug reviews.

Rep. Frank Pallone also said it was unlikely that House and Senate negotiators could agree on an approach for generic biologics in time to include it in the FDA bill.

Pallone said he had concerns about a biogenerics measure that has passed a Senate committee, particularly provisions that might allow "evergreening" by a brand-name maker to extend a product's exclusivity indefinitely. "We're not just going to take the Senate bill," said Pallone, a New Jersey Democrat and chairman of the House of Representatives Energy and Commerce health subcommittee.

If the issue is left out of the FDA legislation, Pallone said he expected additional hearings. "We will try to come up with a consensus and try to work it out with the Senate this year. We're not going to delay it," he said.

Waxman said he was "hopeful" a generic biologics bill would pass before the end of the current Congress, which runs through 2008.

Biotechnology Industry Organization President Jim Greenwood, in a separate briefing with reporters, called Waxman's comments "good news." [Of course he did.] He said his industry doesn't want to be obstructionist in the area of generics, citing that stance by the pharmaceutical industry. "We're acutely aware that some of our products are extremely expensive," he said. But, he later said, "the future of our industry is too important to run an experiment with it." Executives at generic drugmakers called on Congress to act quickly. Hospira Inc (HSP) already is actively developing six generic biologics, Chief Executive Christopher Begley said.

"Now is not the time to wait. Our industry needs to stand behind this issue with all of our force," Begley said.
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