Acting FDA Head to Review Drug-approval Process

Pharmacy Times, Volume 0,0

Interim FDA Commissioner Andrewvon Eschenbach, MD, plans to make anexamination of the drug-review processone of the goals in his new position. Hewants to determine whether theprocess needs changes to "streamlineand accelerate" the approval of newtherapies. Calling the FDA's drugreviewprocess the "gold standard," Dr.von Eschenbach said, however, thatthere is always room for improvement.He cautioned that "speed does notmean recklessness." Any changes madein the drug-approval process will continueto ensure the treatments' efficacyand safety.

When appointed acting FDA leader,Dr. von Eschenbach was serving asdirector of the National Cancer Institute(NCI). He recently relinquisheddaily duties with the NCI to focus solelyon the FDA. Critics had voiced concernsabout his ability to perform bothjobs well, and that he could face a conflictof interest when NCI matters camebefore the FDA. Therefore, he willrecuse himself from FDA reviews ofdrugs researched at NCI, from FDAoversight of potential side effects seenin NCI-sponsored studies, or from"other matters involving NCI as a partyin which the FDA is exercising itsregulatory authority."

Dr. von Eschenbach took over theFDA's reins in September 2005 followingthe sudden resignation of formerFDA Commissioner Lester Crawford,DVM, PhD.

Mr. Rankin is a freelance medical writer.