SOURCES: CRAWFORD'S DISCLOSURE FORMS BOOST CLAIMS OF INDUSTRY BIAS

Financial disclosure forms showing that former FDA commissioner Lester Crawford or his wife owned stock in FDA-regulated companies as late as 2004 have buoyed critics on Capitol Hill, who contend the agency is too cozy with the industries it regulates.

"Lawmakers have been pointing to the lack of ethical standards at the FDA for months, and this just proves that the problems emanate from the very top of the agency," said a Democratic House staffer, who spoke on the condition of anonymity. "If the FDA's leader can't come clean about his ties to industry, what's happening in the rest of the agency?"

The latest attacks on Crawford stem from the HHS' release of financial disclosure forms indicating that during his time as acting FDA commissioner, Crawford or his wife held stock in companies that have some of their business regulated by the FDA. The disclosure forms, which were obtained by The Wall Street Journal under the Freedom of Information Act, show that Crawford reported numerous stock sales in 2004, including shares of medical device manufacturers Kimberly-Clark and Teflex; biotechnology firm Embrex; and food distributor Sysco. The transactions were each valued at between $15,000 and $50,000, according to the Journal.

"Even if the holdings were small, why were they not divested immediately when he returned to the agency?" the staffer asked. "It raises all sorts of red flags."

Crawford rejoined the FDA in 2002 after an earlier stint at the agency and took over as acting commissioner in February 2004 following Mark McClellan's departure to become administrator of the Centers for Medicare & Medicaid Services. President Bush nominated Crawford to become permanent commissioner in February and he was confirmed by the Senate in July in a 78-16 vote. Two months later, Crawford abruptly resigned from the agency, saying only that it was time to "step aside."

Allegations surfaced shortly after Crawford's departure that his resignation was prompted by financial conflicts, but both Crawford and the FDA declined to comment on the charges.

"I think it's too early to tell what, if any, financial conflicts really existed, but it's certainly looking like there may have been some truth to the original allegations," a Senate staffer told FDAnews. "We'll hopefully know more once the HHS investigation is completed." At the request of Sens. Michael Enzi (R-Wyo.), Edward Kennedy (D-Mass.) and other lawmakers, the HHS Inspector General is investigating the circumstances surrounding Crawford's departure, including the allegations that he failed to disclose certain stock holdings.

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