Full article reprinted from "The Pink Sheet" October 7, 2008
Find out why at the one-year anniversary of the FDA Amendments Act, the agency's record is mixed in meeting its increased responsibilities and authorities the law requires.
Full article reprinted from "The Pink Sheet" October 7, 2008
FDA Amendments Act’s One-Year Anniversary: For Better Or Worse
At the one-year anniversary of the FDA Amendments Act, the agency's record is mixed in meeting its increased responsibilities and authorities the law requires.
The changes sweep across a wide swath of the agency, providing continued industry funding for FDA activities and giving the agency a range of options for ensuring drug safety and communicating risk to the public.
So far, FDA has successfully implemented a number of the new provisions, covering issues such as drug safety, transparency and clinical trials. But perhaps due in part to the strains of implementation, the agency is missing a considerable number of user fee deadlines.
One highlight to come out of the reauthorized Prescription Drug User Fee Act IV (Title I in FDAAA) is the increase in new hires, which agency officials hope will address the review delays. The Office of Personnel Management gave FDA direct-hire authority to address the severe staffing shortage.
A Focus On External And Internal Science
The legislation also established the Reagan-Udall Foundation, a public-private partnership that is expected to coordinate post-marketing studies, advance the Critical Path initiative and support the FDA fellowship program.
The Chief Scientific Officer position, held by Frank Torti, was also codified in the legislation. Torti could be the acting commissioner following Commissioner Andrew von Eschenbach's anticipated departure at the end of the Bush administration.
Top agency officials lauded FDA's accomplishments during the past year at a Sept. 26 briefing for reporters with von Eschenbach.
Several key initiatives focused on transparency have been implemented, said Randall Lutter, FDA's deputy commissioner for policy. Waivers for conflict of interest and disclosure of financial information were posted online, although that is only the beginning of the laws requirements in the area. FDA needs to reduce the total number of waivers granted by 25 percent by 2012. On average, drug-related advisory committees have more than two conflicted participants per meeting.
Lutter also highlighted the "reinvigorated effort" to get the best possible experts to fill advisory committee vacancies. The agency has received over 350 nominations for the vacant spots, he said, and has contacted 269 professional organizations, attended 24 professional meetings, and sent out 371 communications seeking qualified members.
Perhaps the section receiving the most attention is Title IX, which provided FDA strengthened post-marketing drug safety oversight. In particular, § 901 - which took effect March 25 - allows FDA to require that sponsors submit Risk Evaluation and Mitigation Strategies to ensure that the benefits of the drug outweigh the risks.
"Establishing Precedent" On Safety Actions
CDER Director Janet Woodcock said FDA is using the REMS requirement "judiciously but strongly." Since March 25, FDA has approved 13 drugs with REMS and sent a notice to 24 sponsors who were deemed to require a REMS on their already-approved products.
Woodcock noted that in implementing the REMS provision the agency is "establishing precedent," which has delayed approval of several drugs, including Adolor/GlaxoSmithKline's Entereg (alvimopan) and Amgen's Nplate (romiplostim).
The bill also instructs FDA to assess drug marketing more directly. The agency is working to develop standards on how best to convey information in DTC drug ads, including providing a toll-free number and Web site for consumer reporting.
Pilot projects for the Sentinel network, a national network of existing electronic data systems, are ongoing. The goal, Woodcock said, is to have access to data from 25 million patients by July 1, 2010 and 100 million two years later.
Information technology and data center management is a priority for the agency; FDA announced Sept. 30 the selection of 10 contractors with extensive government experience, which will receive up to $2.5 billion over the next 10 years.
- Becky Jungbauer
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