Crawford Resigns From FDA 40140

Crawford Resigns From FDA

WASHINGTONTwo months afterhis long-awaited confirmation, Lester Crawford, D.V.M., Ph.D., abruptly resignedSept. 23 from his post as commissioner of the Food and Drug Administration(FDA), without providing any concrete reason for his departure. In a note to FDAstaff, Crawford said, After three years as deputy commissioner, actingcommissioner and, finally, as commissioner, it is time, at the age of 67, tostep aside. In a letter to President Bush, Crawford said his resignation waseffective immediately. Bush promptly appointed fellow Texan Andrew vonEschenbach, M.D., an oncologist and current head of the National CancerInstitute (NCI) of the National Institutes of Health (NIH), as FDAs actingcommissioner.

Under Crawford, FDA had been criticized and divided on manydrug and medical issues, including a contentious battle over Crawfords delayon the approval of over-the-counter (OTC) status for emergency contraceptivePlan B. He also suffered credibility damage as a result of investigations into areported extramarital affair, on which he was accused of spending governmentfunds. On dietary supplements, Crawford had been improving his awareness andunderstanding of the industry, according to the National Nutritional FoodsAssociation (NNFA) and the American Herbal Products Association (AHPA), whichhad been working to bring Crawford up to speed on supplement issues, much asthey did with his predecessor Mark McClellan, M.D., Ph.D.

While many members of Congress, primarily Democrats, praisedCrawfords resignation and the opportunity it provides for FDA overhaul,others said Crawford had begun to lift the veil on how the agency does business. Some were also concerned about what theleadership turnover at FDA will mean for the regular business and currentpriorities in the agencys many divisions, including the Office of DietarySupplements (ODS).

Michael McGuffin, president of AHPA, expressed hisdisappointment at the new vacancy at FDA. Among McGuffins concerns werehow the resignation and ensuing period of an unconfirmed FDA leader will affectthe agencys enforcement of the Dietary Supplement Health and Education Act(DSHEA), namely key supplement issues such as New Dietary Ingredients (NDIs) andGMPs (good manufacturing practices). The final GMP rule may well be delayed fromits reported fourth quarter completion, and there are concerns that the rulewill not be put forth without the signature of a confirmed commissioner.

David Seckman, president and chief executive officer (CEO) ofNNFA, echoed the concern, but said the association will continue itscommunications and efforts with FDA and its new acting commissioner, notingthere is a possibility the release of GMPs may only be slightly further delayed.He added while Crawfords resignation was a surprise, turnover at FDA has beena regular occurrence. In fact, there has been a permanent FDA commissioner foronly 18 months of the four and a half years of the Bush Administration.

It is widely thought Bush may not nominate a permanentreplacement for quite a whilesome say as long as 18 monthsdue to thepoliticization of the post and the resulting difficulty of winning confirmationin the Senate. In the interim, von Eschenbach will serve as head of both FDA andNCI, a dual role that worries some experts. He said he will remain totally,completely and absolutely dedicated to NCI, but also released statementsunderscoring his commitment to FDA.

Both a cancer doctor and survivor, von Eschenbach has chargedthe NCI with eliminating suffering and death due to cancer by 2015. For FDA, hesaid he has no plans to drastically alter the direction of the agency and will,instead, rely on the experienced staff and continuing initiatives begun underCrawford and McClellan. This includes bridging the gap between regulation andmodern science, strengthening the ties between FDA and NCI, and making safetyinformation more available to patients. He has yet made no comment on dietarysupplement issues.