Ex-FDA Commissioner Pleads Guilty To Conflicts Of Interest, False Statements

Former FDA Commissioner Lester Crawford pleaded guilty in D.C. federal court Oct. 17 to owning company stocks that caused conflicts of interest and to making false statements about those stock holdings during his tenure at the agency.

The pleas could add more ammunition for critics that have charged FDA with putting other considerations before objective science in carrying out its day-to-day functions.

The U.S. District Court Judge accepted Crawford's pleas on the two misdemeanor counts of making false writings and conflict of interest and scheduled a sentencing hearing for Jan. 22.

The plea agreement includes sentencing guidelines of a "0-6 month" prison term and fines, according to Crawford's attorney Barbara Van Gelder. She said she expects him to be placed on probation, rather then get a jail sentence.

"The government has agreed that Dr. Crawford's conduct puts him at the 'low end of the range,'" Gelder said.

The charges deal with stocks held by Crawford and his wife throughout 2003, when he was still FDA deputy commissioner, and continuing through his tenure as commissioner, which ended on Sept. 23, 2005 when Crawford abruptly resigned (¹ , p. 3).

Crawford became acting FDA commissioner in March 2004 and was confirmed as commissioner in July 2005.

According to the Department of Justice, Crawford's federal financial disclosure documents on July 1, 2004 revealed his ownership of Sysco and Kimberly-Clark stock.

"An HHS ethics official inquired about Crawford's ownership of stock in these significantly regulated organizations. On or about December 28, 2004, in an email to the HHS ethics official, Crawford stated, 'Sysco and Kimberly-Clark have in fact been sold,'" the DoJ court filing says.

"In truth and in fact, as Crawford then knew, Crawford and/or his wife held shares in both Sysco and Kimberly-Clark through 2003 and 2004," the document says.

Kimberly-Clark makes medical devices including respiratory management systems, enteral feeding devices and endoscopy products. Sysco is a food company.

Additionally, Crawford and his wife allegedly failed to disclose "his income from the Nov. 17, 2004 exercise of Embrex stock options or Crawford's ownership of Kimberly-Clark or Sysco stock" when Crawford filed his nominee disclosure document with HHS and the Senate Health, Education, Labor and Pensions Committee in February 2005.

"Crawford had earned $20,627.36 in income in 2004 from the exercise of Embrex stock options and Crawford and/or his wife owned a minimum of about $48,000 in Sysco stock and a minimum of about $62,000 in Kimberly-Clark stock during 2004," according to DoJ charges.

At that time, he also allegedly continued to hold options to purchase 30,000 shares of stock in the agricultural biotechnology firm Embrex.

The conflict of interest issues date back prior to Crawford's appointment as acting FDA commissioner. In August 2003 he was appointed by then-FDA Commissioner Mark McClellan to serve as chairman of the Obesity Working Group, and he testified to the House Committee on Government Reform on the government's role in combating obesity in June 2004. During this time period, the DoJ says that Crawford and his wife owned shares in PepsiCo and Sysco, which had financial interests in the agency's obesity policies.

In response to the DoJ court filing Oct. 16, frequent FDA critic Rep. Maurice Hinchey (D-N.Y.) said the action "underscores the fact that FDA...is in need of a serious overhaul." Hinchey is on the House Appropriations Subcommittee that handles FDA's budget.

The HHS Inspector General initiated an investigation into Crawford's resignation last year at the behest of Hinchey and four Democratic colleagues; findings have yet to be reported.

Questions regarding Crawford's tenure as FDA commissioner have also been raised as part of a civil lawsuit challenging the agency's handling of Barr's Plan B OTC switch application (² , p. 13).

- David Filmore ([email protected])