FDA Reform Bill Could Still Face Administrative Gauntlet After Enactment
FDA has yet to determine how quickly it can exercise new authorities created by the FDA Amendments Act of 2007, agency officials told reporters Sept. 27, a few hours after President Bush signed H.R. 3580 into law.
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.
The 200 provisions of the law authorize a multitude of activities, such as the collection of prescription drug user fees, including new assessments earmarked for safety, an active safety surveillance system, the creation of a clinical trial results database, new user fees for FDA review of DTC television ads and agency authority to require review of such ads (1"The Pink Sheet" DAILY, Sept. 19, 2007).
Enactment of the FDA Amendments ends the threat of reduction in force notices to user fee-funded FDA employees, but Congress has yet to appropriate the money for paying federal employees in FY 2008, which begins Oct. 1. A Continuing Resolution, which funds government operations at FY '07 levels through Nov. 16, was adopted by the House, 404-14, on Sept. 26, and scheduled for action by the Senate late on Sept. 27. An Agriculture/FDA Appropriations bill has passed the House but is not expected to be considered on the Senate floor until at least the second week in October.
-Cathy Dombrowski
This article is reprinted from "The Pink Sheet" DAILY – September 28, 2007
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