Former FDA Commissioner Under Investigation

The tenure of Dr. Lester M. Crawford as FDA Commissioner was a short one, with his resignation in September coming less than three months after his confirmation.

Dr. Crawford’s stay at the FDA as deputy commissioner, acting commissioner, and then as commissioner was never without controversy and his critics inside the agency, in Congress, and among consumer advocates often accused him of making decisions based on political considerations and not on medical or scientific grounds.

The inordinate (three-year) delay in acting on Barr Laboratories’ application to approve the over-the-counter (OTC) sale of the emergency contraceptive Plan B was seen by many as being driven by politics, although Dr. Crawford maintained his actions were motivated solely by scientific and legal considerations.

The delays prompted a federal lawsuit by an abortion rights group (Center for Reproductive Rights – CRR), which is proceeding in U.S. District Court for the Eastern District of New York. The group plans to conduct depositions of Dr. Crawford and other agency officials with respect to the FDA’s actions (or inactions).

The lawsuit seeks to compel the FDA to approve Plan B for OTC sale and is being brought by the Center for Reproductive Rights on behalf of a number of other groups including the Association of Reproductive Health Professionals, the National Latina Institute for Reproductive Health.

In October, the Department of Health and Human Services disclosed documents that indicated Dr. Crawford and his wife had sold shares of stock in FDA-regulated companies while he was both acting commissioner and commissioner of the agency.

Shortly after resigning as commissioner, Dr. Crawford joined Policy Directions, Inc., a Washington DC lobbying firm.

In a court hearing related to the Plan B-delay controversy, it was disclosed by Dr. Crawford’s attorney that he was currently under investigation by a federal grand jury concerning allegations of financial wrongdoing and lying to Congress.

The criminal investigation will certainly impact on discovery proceedings in the civil case since it is likely that Dr, Crawford will invoke his Fifth Amendment right against self-incrimination to any questions posed at his deposition. Although Dr. Crawford is represented by the Justice Department in the civil suit, it was his private attorney who indicated she would instruct him to refuse to answer questions at the deposition. Dr. Crawford has already refused to answer inquiries from the GAO (Government Accountability Office) with respect to Plan B.

Previously published reports indicated that the depositions that had been scheduled from last Wednesday through Friday included Dr. Crawford as well as FDA Deputy Operations Commissioner Janet Woodcock and Steven Galson, director of FDA’s Center for Drug Evaluation and Research.

Those depositions promised to thoroughly explore the issue of the delays by the FDA on the Plan B OTC application. In May 2004, The agency issued a “not approvable” letter in response to an original application submitted by Barr to authorize OTC sales of Plan B, citing inadequate data on its use among girls ages 16 and younger.

In a revised application, Barr proposed to make OTC Plan B available only to females 17 and older. In January 2005, the FDA announced a delay in its decision on the revised application. The federal lawsuit then challenged the FDA actions claiming the agency failed to follow its own procedures when it denied the original application.

The lawsuit also alleged that the denial of OTC sales violated women’s rights to equal protection and privacy as guaranteed by the U.S. Constitution.
In August 2005, Dr. Crawford opened a 60-day public comment period on Barr’s application and said that science supports giving OTC access to Plan B to women ages 17 and older. Crawford appeared to hedge his bets, however, by adding that the OTC application presented the agency “with many difficult and novel policy and regulatory issues,” including how to keep girls ages 16 and younger from obtaining the drug.

Although the comment period ended in November 2005, the agency did not indicate when it might make a decision on the application. A March, 23, 2004, memo written by Curtis Rosebraugh, an FDA medical officer, indicated that he found no reason to reject Barr’s application.

That memo said that Dr. Woodcock had stated that “we could not anticipate or prevent extreme promiscuous behaviors such as the medication taking on ‘urban legend’ status that would lead adolescents to form sex-based cults centered around the use of Plan B.”

Prior to Dr. Crawford’s confirmation as commissioner, Michael O. Leavitt, Secretary of Health and Human Services, had promised that the FDA would act on Barr’s OTC the Plan B application by September 2005. That assurance led Democratic senators like Hillary Rodham Clinton (NY) and Patty Murray (WA) to abandon their efforts to delay Crawford’s nomination. Once confirmed, however, Dr. Crawford announced the indefinite delay that remains in effect.

Interestingly, the Justice Department may find itself on both sides of the Crawford controversy since it is defending him and his actions as FDA commissioner in the civil Plan B suit, while it may also be investigating criminal wrongdoing by Crawford in the very same matter.

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