February 21, 2006

The FDA is not doing enough to ensure that its employees' outside activities comply with federal conflict-of-interest requirements, according to an HHS Office of Inspector General (OIG) report -- a conclusion the FDA rejects.

The agency fails to receive sufficient information from its employees about their outside activities and has fundamental problems with its review process that prevents the FDA from effectively reviewing outside activity requests, the OIG said in a recent report.

For example, most of the HHS-520 forms that FDA personnel are required to submit along with the requests lacked at least one piece of required information. Also, when the information was provided, it often included only vague or minimal information, the report finds. The number of deficiencies in these submissions "raise systemic concerns" about how the agency collects and reviews this information, the OIG said.

Additionally, the OIG concluded that the review process itself was inadequate. For example, 23 of the 55 outside activity requests reviewed for senior-level employees were approved after the start date. Also, seven activities were approved for longer than the five-year maximum period allowed under agency regulations.

The OIG recommended that the FDA take numerous steps to address these problems. Among them, the agency should require all employees to submit additional details on the nature of their proposed outside activities, ensure that all employees fill out their outside activity requests completely, and cross-check disclosure forms with those employees' outside activities for the previous year, the OIG said.

The OIG also called for the FDA to develop complete policies and procedures on outside activities for all centers and employees, ensure that these activities are approved before their scheduled start date and for periods not exceeding the maximum time allowed by the FDA or HHS.

The FDA, however, rejected the OIG's finding, arguing that initiatives it implemented over the last year already address the OIG's concerns.

The report, "Outside Activities of FDA Employees," is available at: http://oig.hhs.gov/oei/reports/oei-01-04-00400.pdf (http://oig.hhs.gov/oei/reports/oei-01-04-00400.pdf).