FDA Employees Shed Insight on Agency's Activities, Goals

Employees of the US Food and Drug Administration (FDA) have had a busy week (23-27 April), speaking at a wide range of events and venues.

Regulatory Focus is happy to bring you a brief recap of their remarks in one centralized location.

• Margaret Hamburg, Commissioner, FDA: Hamburg said at a conference this week she experts this year to be "a landmark year" for legislative improvements to FDA's authority, but said it remains "difficult to predict" what form legislation will ultimately take. Hamburg also outlined her agency's approach to nanotechnology, saying she believes its approach to nanotechnology regulation will become "more nuanced" over time.
• Deborah Autor, Associate Commissioner for Global Regulatory Operations, FDA: Autor told attendees of a conference this week that she hopes to improve the agency's handling of inspections in an increasingly globalized environment.
• Janet Woodock, Director, Center for Drug Evaluation and Research, FDA: Woodcock gave a presentation at a meeting in California, and later answered a wide range of issues, including capital requirements, transparency, cooperation with other federal agencies, scientific challenges, cooperation with regulated industry, funding, submission data and diseases. Woodock's presentation and a transcript of her Q&A session are both online.  Woodcock also told a meeting of healthcare journalists she believes FDA's resources are now equally split between postmarketing and premarketing regulatory issues, with surveillance now taking up half of the agency's time and effort.
• Daniel Fabricant, Director, Dietary Supplement Program, FDA: Fabricant blasted the supplement industry in remarks made in a webcast, saying the agency is 'aghast' at the lack of compliance with good manufacturing practices and industry's failure to comply to repeated warning letters.
• Jesse Goodman, Chief Scientist and Deputy Commissioner for Science and Public Health, FDA: Goodman sat down for an interview with FDA's blog, FDA Voice, and talked about the agency's work with Defense Advanced Research Projects Agency (DARPA) and the National Institutes of Health (NIH) to develop new drug development tools.
• Douglas Throckmorton, Deputy Director for Regulatory Programs, Center for Drug Evaluation and Research, FDA: Throckmorton also sat down with FDA Voice to describe the agency's efforts to cut down on prescription drug abuse through the increased use of inter-agency cooperation, restriction programs and organizational partnerships.