Acting FDA Head to Review Drug-approval Process

Ken Rankin
Published Online: Tuesday, November 1, 2005

Interim FDA Commissioner Andrew von Eschenbach, MD, plans to make an examination of the drug-review process one of the goals in his new position. He wants to determine whether the process needs changes to "streamline and accelerate" the approval of new therapies. Calling the FDA's drugreview process the "gold standard," Dr. von Eschenbach said, however, that there is always room for improvement. He cautioned that "speed does not mean recklessness." Any changes made in the drug-approval process will continue to ensure the treatments' efficacy and safety.

When appointed acting FDA leader, Dr. von Eschenbach was serving as director of the National Cancer Institute (NCI). He recently relinquished daily duties with the NCI to focus solely on the FDA. Critics had voiced concerns about his ability to perform both jobs well, and that he could face a conflict of interest when NCI matters came before the FDA. Therefore, he will recuse himself from FDA reviews of drugs researched at NCI, from FDA oversight of potential side effects seen in NCI-sponsored studies, or from "other matters involving NCI as a party in which the FDA is exercising its regulatory authority."

Dr. von Eschenbach took over the FDA's reins in September 2005 following the sudden resignation of former FDA Commissioner Lester Crawford, DVM, PhD.

Mr. Rankin is a freelance medical writer.



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