Generic Biologics Bill Unlikely To Pass

Make a comment

copycat2.jpgLawmakers are unlikely to add generic biologics legislation to an FDA bill that’s expected to receive congressional approval this month, two key U.S. congressmen said on Thursday, reports Reuters. Generic drugmakers have been pushing legislation that would chart a specific path for the FDA to approve cheaper copycat versions of biotech meds.

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. Rep. Frank Pallone, a New Jersey Democrat, 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.

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.

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, who chairs 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.

Jim Greenwood, who heads BIO, called Waxman’s comments “good news.” He says biotechs don’t want to be obstructionist in the area of generics. “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. “Now is not the time to wait,” said Chris Begley, ceo at Hospira, which is actively developing six generic biologics. “Our industry needs to stand behind this issue with all of our force.”

Jump to comments

Share

Comments are closed.

Subscribe

RSS Feed

Comments feed for this post only.

Tags

, , , , , ,

Clear

Clear

© 2007- 2008 Newark Morning Ledger Co.  All Rights Reserved.

Thanks for trying out the new Pharmalot printing tools. If you're got any suggestions for how we can help you print better, please let us know by clicking on the contact link at http://www.pharmalot.com/