Opportunities for 2008 - Pharmaceutical Technology

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Opportunities for 2008
As FDA implements new drug-safety policies, manufacturers will focus on quality and pricing.


Pharmaceutical Technology
Volume 32, Issue 1

This underlying concern that drug manufacturers exercise too much control over FDA policies has emerged in connection with the role of the new Reagan–Udall Foundation. FDAAA created the group to support innovation and enhance safety for FDA-regulated products. FDA complied with the law's 30-day requirement to appoint the 14-member panel, which is chaired by former FDA commissioner Mark McClellan and includes representatives from industry, academia, consumer groups, and healthcare providers. But Rep. Rosa DeLauro (D-CT), who chairs the House Appropriations subcommittee in charge of FDA's budget, has raised objections. She says that the organization will be overly influenced by industry and may encourage the development of profitable, but not necessarily safe, drugs. DeLauro plans to hold hearings on the Reagan–Udall Foundation and other COI issues, a sign that FDA and pharmaceutical manufacturers will continue to face many challenges in the year ahead.

Whither FDA “revitalization?”

Through most of the debate about US Food and Drug Administration safety and user-fee legislation last year, the bill under discussion was called the FDA Revitalization Act, or FDARA. But the final measure has the unhappy acronym FDAAA, and no one knows what to call it. Names are important in Washington, where keeping track of acronyms can be a full-time job. FDA has benefited from many catchy ones over the years (i.e., FDAMA, PDUFA, PREA). But “Fdaaaah” does not measure up. FDA Chief of Staff Susan Winckler tried “FD-triple-A” at the Food and Drug Law Institute conference in November 2007, but that name is pretty cumbersome. And “FDA cubed” doesn’t fly, either. A Congressional staffer somewhere is responsible for this acronym crime, but so far no one has assumed responsibility.

Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634,


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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
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70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
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