Article preview from "The Pink Sheet" April 28, 2009
Prospects for enactment of follow-on biologics legislation appear limited in the near term, according to Capitol Hill players in the debate. Read on...
Article preview from "The Pink Sheet" April 28, 2009
Prospects for enactment of follow-on biologics legislation appear limited in the near term, according to Capitol Hill players in the debate.
Rep. Henry Waxman's Health Counsel, Ann Witt, told a policy forum sponsored by the Jefferson School of Population Health on April 21, "I don't know what's going to happen with these bills."
"Although this is a very high priority of Mr. Waxman's, there are some other high priorities right now in the Energy & Commerce committee - mainly health care reform and climate change - and finding time to get this bill through is challenging," she said.
At the FDA/Food & Drug Law Institute's annual meeting the next day, Sen. Orrin Hatch, R-Utah, also suggested a lack of momentum, noting only "we're working on it."
In terms of the structure of a bill, "Henry's going to have to come up" with the length of exclusivity offered brand products, Hatch said.
"When Congressman Waxman is here, you might encourage him to come on board," Hatch said. Waxman, whose 1984 deal with Hatch to create an approval pathway for small molecule generics is one of the pharma industry's seminal turning events, had been scheduled to speak with Hatch on Wednesday. But by the time Hatch gave his address, Waxman had moved his speech to Thursday afternoon. He ended up cancelling that as well, citing a large number of votes on the floor.
Waxman Faces Challenge In The House...
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