FDA expands disclosure

After what it termed a "comprehensive review" of more than 1800 previously approved requests from its employees to engage in "outside activities," the US Food and Drug Administration (FDA) has expanded the number of scientists and officials required to file confidential financial disclosure forms. The action comes as a congressional panel continues to scrutinize ethics and financial conflicts of interest rules at the FDA, the National Institutes of Health (NIH), and other federal agencies.A panel of four senior FDA officials reviewed more than 1800 Form 520s, "Request for Approval of Outside Activity," over a 4-week period beginning in mid May. The team did not find any paid or unpaid outside activities as being "of concern." Nevertheless, acting FDA Commissioner Lester M. Crawford ordered the "strengthening" of ethics regulations by instructing nonadministrative employees at the GS-13 level and above, those with spending authority in excess of $25,000, and all attorneys to file declarations of financial holdings. "This review shows that the aggressive disclosure and review process designed to prevent conflicts of interest is working well," Crawford said in a statement earlier this month. "Nevertheless, I am further strengthening our disclosure and review program so that the impartiality of FDA's science-based regulatory decisions will continue to be above question."But Rep. James Greenwood (R-Penn.), chairman of the House Energy and Commerce Subcommittee on Oversight and Investigations, said the FDA review process seemed "a tad cursory," with the reviewers appearing to have spent an average of 10 minutes per document. Greenwood has instructed the FDA to provide the subcommittee with all records of paid speaking engagements and honoraria since 1999. "Our policy is to trust but verify," Greenwood told The Scientist. "I would hope that the [FDA] reviewers have gone from what might have been a rubber stamp approach to one where they know we're looking over their shoulder."FDA spokesman Lawrence Bachorik told The Scientist that the 10-minute-per-document review time for each Form 520 seemed reasonable. "They were looking for whether the activity being requested would have been prohibited, such as working for or somehow receiving reimbursement from a company that we significantly regulate," Bachorik said. "Even 10 minutes, as an average, doesn't give me much pause, because it's not real complicated."In late 2002, FDA ethics officers had approved a Form 520 request from Emanuel F. Petricoin, lead microbiologist with FDA's Center for Biologics Evaluation and Research, to enter into a paid consulting arrangement with Biospect—now Predicant Biosciences—a South San Francisco life sciences company. After congressional inquiries, FDA officials determined that Biospect was a "significantly regulated entity" with which FDA employees are barred from consulting. Petricoin severed his ties to the company in early May. In February 2004, FDA ethics officers approved Petricoin's Form 520 request to receive an honorarium and travel expenses to speak at an epidermal growth factor receptor seminar in Florida. After receiving permission, Petricoin said he looked more carefully at the agenda he had attached to the request and noticed the seminar was being sponsored by ImClone Systems and Bristol-Myers Squibb. Despite FDA approval, Petricoin decided not to attend the conference. In a June 4 memo to all FDA employees, Crawford said that "effective immediately," all outside activity requests would be evaluated only by center directors and senior officials, a responsibility that "may not be delegated." FDA will also conduct annual reviews of outside activities, linking each to financial disclosure statements. "In the current dynamic environment, an annual review offers better protection against conflicts of interest," Crawford wrote.The House Oversight and Investigations subcommittee last week (June 18) expanded its investigation into outside employee compensation by requesting all 15 federal agencies under its jurisdiction to supply documents relating to awards, contracts, and outside funding to employees since 1999. NIH Director Elias A. Zerhouni will appear before the panel tomorrow (June 22) to discuss his recommendations to resolve conflict-of-interest problems at that agency.

FDA expands disclosure

Review of 1800 outside activity requests 'cursory,' key lawmaker says

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