Crawford Resigns From FDA

WASHINGTON--Two months after his long-awaited confirmation, Lester Crawford, D.V.M., Ph.D., abruptly resigned Sept. 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 FDA staff, Crawford said, After three years as deputy commissioner, acting commissioner and, finally, as commissioner, it is time, at the age of 67, to step aside. In a letter to President Bush, Crawford said his resignation was effective immediately. Bush promptly appointed fellow Texan Andrew von Eschenbach, M.D., an oncologist and current head of the National Cancer Institute (NCI) of the National Institutes of Health (NIH), as FDA's acting commissioner.

Under Crawford, FDA had been criticized and divided on many drug and medical issues, including a contentious battle over Crawfords delay on the approval of over-the-counter (OTC) approval for emergency contraceptive Plan B. He also suffered credibility damage as a result of investigations into a reported extramarital affair, on which he was accused of spending government funds. On dietary supplements, Crawford had been improving his awareness and understanding of the industry, according to the National Nutritional Foods Association (NNFA) and the American Herbal Products Association (AHPA), which had been working to bring Crawford up to speed on supplement issues, much as they did with his predecessor Mark McClellan.

While many members of Congress, primarily Democrats, praised Crawfords 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 the leadership turnover at FDA will mean for the regular business and current priorities in the agencys many divisions, including the Office of Dietary Supplements (ODS).

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

David Seckman, president and chief executive officer (CEO) of NNFA, echoed the concern, but said the association will continue its communications and efforts with FDA and its new acting commissioner, noting there 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 been a regular occurrence. In fact, there has been a permanent FDA commissioner for only 18 months of the four and a half years of the Bush Administration.

It is widely thought Bush may not nominate a permanent replacement for quite a while--some say as long as 18 months--due to the politicization of the post and the resulting difficulty of winning confirmation in the Senate. In the interim, von Eschenbach will serve as head of both FDA and NCI, a dual role that worries some experts. He said he will remain totally, completely and absolutely dedicated to NCI, but also released statements underscoring his commitment to FDA.

Both a cancer doctor and survivor, von Eschenbach has charged the NCI with eliminating suffering and death due to cancer by 2015. For FDA, he said he has no plans to drastically alter the direction of the agency and will, instead, rely on the experienced staff and continuing initiatives begun under Crawford and McClellan. This includes bridging the gap between regulation and modern science, strengthening the ties between FDA and NCI, and making safety information more available to patients. He has yet made no comment on dietary supplement issues.