Former FDA Commissioner Faces Charges Over Conflicts of Interest

Lester M. Crawford, the former head of the U.S. Food and Drug Administration, has been charged by the Justice Department for failing to disclose investments in corporations that were subject to his agency’s oversight. Crawford is expected to plead guilty in federal court on Tuesday to two misdemeanors: filing a false document and conflict of interest.

Crawford, 68, allegedly lied about his holdings in several companies by filing erroneous statements that claimed he had sold the investments in question. According to prosecutors, Crawford “knowingly made” false statements with regard to his ownership stake in several companies, including Kimberly-Clark, PepsiCo, and Sysco–each of which are considered “significantly regulated” companies by the FDA, therefore making them off-limits to FDA employees. Crawford also failed to disclose his exercise of stock options in the biotech company Embrex. Remarkably, Crawford had served in 2003 and 2004 as chairman of the FDA’s Obesity Working Group at the same time that he owned shares in soft-drink maker PepsiCo and snack distributor Sysco, two companies that would have been affected by that group’s findings.

The veterinarian had served as deputy commissioner of the FDA from February of 2002 until March of 2004, at which point he was named acting commissioner. In February of 2005, he was nominated for the permanent commissioner’s role and was eventually confirmed by the Senate on July 18 of that year. However, Crawford resigned abruptly and without explanation less than three months later after a tumultuous and controversial tenure. Among the issues he faced as FDA head were the removal of Vioxx from the market due to safety concerns; a recall of malfunctioning heart devices; and tainted flu vaccines.

However, the biggest controversy of his term revolved around the delayed approval of over-the counter sales of emergency contraceptive pill Plan B. His Senate confirmation was a prolonged process, in part because of his failure to approve the drug, and it was only after he signaled a willingness to reverse course that he was confirmed. Yet in August of 2005, Crawford decided to once again delay approval of the pill indefinitely, despite assurances by FDA scientists that the pill was safe. Critics accused him of basing his decision on politics, as opposed to science or medicine, and the FDA’s chief of women’s health, Susan Wood, subsequently tendered her resignation in protest. It was during a court hearing in April of this year regarding his agency’s handling of the Plan B affair that it was revealed that Crawford was under criminal investigation for financial improprieties.

President Bush nominated Crawford for the permanent commissioner’s position in 2005 despite the fact that the FDA had come under significant fire during his tenure as acting commissioner for being too lenient in its approval of pharmaceuticals. At the time of his resignation last year, Sen. Barbara Mikulski, a Democrat from Maryland (home of the FDA’s offices), had said, “Lester Crawford’s leadership at FDA since 2002 has been both tepid and passive.” Sen. Hillary Rodham Clinton, D-NY, added: “With the resignation of Dr. Crawford, the FDA has a real opportunity to restore its battered reputation and nominate a leader with vision and drive to ensure that the FDA upholds its gold standard of drug regulation. The FDA needs a Commissioner who improves the internal morale at the Agency and ensures that the voices of medical and scientific experts are heard.”

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