[Source: Health and Lifes Sciences Daily, Sept. 28, 2007]
The AP (9/28, Bridges) reports that on Thursday, President Bush signed the Food and Drug Administration Amendments Act of 2007 (H.R. 3580 ), which grants the FDA "broad new powers to ensure the safety of prescription drugs used by millions of Americans." The new law reauthorizes, for five years, "programs to collect fees from drug and medical device manufacturers," with drug companies expected to pay "$393 million, and medical device makers $48 million, in various fees next year." FDA Commissioner Dr. Andrew von Eschenbach noted, "It really represents an important addition to the FDA's authority." The legislation grants the FDA "the power both to require drug companies to do further study on the safety of medicines, if needed, and to mandate new label warnings when problems do appear. The FDA also gains the ability to fine companies to ensure compliance with those two new authorities." Moreover, the new law "requires companies to publicly release results of all clinical trials that show how well their approved drugs performed. Not-yet-approved drugs could be subject to the requirement later." The AP notes, "The FDA was still reviewing the 156-page law and its roughly 200 specific provisions, many with timelines, before deciding how to implement them."
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FDALegislativeWatch.com reviews the new bill.
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Patent Baristas reviews the new bill.
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FDA has yet to determine how quickly it can exercise new authorities created by the FDA Amendments Act of 2007
[Source: FDALegislativeWatch.com]
The question is whether the new authorities "are self-implementing or whether they need clarification in the form of a reg or a guidance," Deputy Commissioner for Policy Randall Lutter said.
If regulations or guidance are necessary, agency use of new tools - such as the ability to order drug companies to make labeling changes, conduct post-approval clinical trials or develop risk evaluation and mitigation strategies - will be delayed as the agency goes through public comment procedures.
Complicating implementation of the statute is its size and scope. "There appears to be at least 200 specific provisions, many of which have timelines that have been identified within the bill itself," Commissioner Andrew von Eschenbach pointed out. An implementation strategy will be evolving during the coming weeks and months, he said.
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