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Re: DewDiligence post# 5354

Thursday, 09/06/2007 6:38:55 PM

Thursday, September 06, 2007 6:38:55 PM

Post# of 6489
The article sounds as if the hurdle may be that they want even more capability for biogenerics than the Senate version allows -

"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. "

It also appears that the Representatives are still very hopeful and motivated to get biogenerics eventually passed -

"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"

Overall, still very promising, and all very positive for FoB legislation to eventually pass - but may not happen until next year. No one is claiming to be against this bill in principle. If anything, they want to pass legislation even more advantageous to biogenerics, at the expense of delaying final approval.

That is my take on the article - other opinions welcome -

JS





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