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FDA Woodcock二次上任 受产业界欢迎
FDA Taps Chief
For Drug Center
Amid Scrutiny
By ANNA WILDE MATHEWS
March 11, 2008; Page B10
The Food and Drug Administration said former drug-center head Janet Woodcock will return to that post on a permanent basis.
Dr. Woodcock's second stint in the job, which she has held on an acting basis since September, is likely to be generally welcomed by the drug industry. Though she is seen as tough, she is a seasoned hand, having begun her previous directorship of the FDA's Center for Drug Evaluation and Research in 1994. In 2005, she was appointed a deputy commissioner at the FDA, later adding the title of chief medical officer.
Dr. Woodcock, 59 years old, will relinquish both positions, an FDA spokeswoman said.
Because she is an architect of the FDA's current approach to drug regulation, industry officials don't view her as likely to attempt wholesale reversals.
Still, Dr. Woodcock, an internist and rheumatologist, will take back her former job at a challenging time, overseeing major transitions at the center.
Her first and biggest task will be to implement a major law passed last year that will require the hiring of hundreds of new staffers and the drawing up of procedures to implement new authority over drugs already on the market. Under the new law, the FDA is able to take various actions if it believes a drug carries a potential safety concern, including requiring new studies and limiting distribution.
Dr. Woodcock will also take over as Congress has the FDA under particularly close scrutiny. A number of outside groups have said the agency needs more funding and changes in its culture and approach. Some drug-industry officials have ramped up their public venting of concerns that the FDA has become too risk-averse in its approvals, slowing the arrival of new treatments.
Among the congressional investigations focused on the agency are probes into its handling of the Sanofi-Aventis SA antibiotic Ketek and the safety of heparin, the blood-thinner that has been linked to hundreds of allergic reactions and some deaths.
Janet Woodcock M.D
（缩略图，点击图片链接看原图） Janet Woodcock专访：让医疗产品更好更便宜
Making Medical Products Better, Faster, and Cheaper
Date Posted: September 10, 2007
What FDA's Critical Path Initiative Means to Consumers
Q and A with Janet Woodcock, M.D.
PSC / Cathy Brown
Printer-friendly PDF (206 KB)
http://www.fda.gov/consumer/updates/criticalpath091007.pdf
Janet Woodcock, M.D., is FDA's Deputy Commissioner for Scientific and Medical Programs and Chief Medical Officer. Dr. Woodcock received her medical degree from Northwestern Medical School, and completed further training and held teaching appointments at the Pennsylvania State University and the University of California in San Francisco. She joined FDA in 1986.
Q. How do scientific discoveries affect the development of medical products?
A. In recent years, there has been an explosion of scientific discoveries made possible through technologies such as genomics, advanced imaging, nanotechnology, and robotics. These scientific advances can help produce more and better medical products—not just drugs, but biologics such as vaccines, and devices such as pacemakers.
But the efficiency for scientific discoveries being translated into medical products is very low—in fact, it's worse than it was 10 years ago. For example, new drugs go through three phases of progressively rigorous testing, or clinical trials, to show their safety and effectiveness before FDA will consider allowing them on the market. Today, new compounds that make it through Phases 1 and 2 of clinical trials fail 50% of the time in Phase 3 compared to a 20% failure rate 10 years ago.
Q. Why is there a slow-down in the availability of medical products?
A. In FDA's view, new science is not being used to guide the medical product development process in the same way that it is accelerating the discovery process. The path that a medical product takes from development to mass-production and availability to the public—what we call the Critical Path—has become increasingly challenging, inefficient, and costly.
Q. What is the Critical Path Initiative?
A. The Critical Path Initiative, launched in 2004, is FDA's effort to stimulate and assist a national effort to modernize the scientific process—the Critical Path—through which FDA-regulated products are developed, evaluated, and manufactured. We need to improve this Critical Path so we can move medical discoveries from the laboratory to consumers more efficiently.
Q. How can medical products be developed more efficiently?
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作者:admin@医学,生命科学 2011-01-25 05:14
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