FDA has announced the results of a comprehensive review of all outside activities performed by FDA employees

Dr. Lester M. Crawford, Acting Commissioner of the Food and Drug Administration (FDA), has announced the results of a comprehensive review of all "outside activities" performed by FDA employees. In responding to the findings of an internal review at FDA of approved outside activities, Dr. Crawford said: "I am pleased to report, based on the review of all approved outside activity requests submitted by covered employees, that the review team did not identify any additional approved outside activities of concern beyond the one exception that was previously identified and promptly remedied last month upon discovery. I commend all FDA employees and Center management for upholding the highest ethical standards. This review has verified and validated my belief that FDA employees understand the importance and need for the rules and regulations applicable to the Agency's outside activities."

As a result of one incident being identified within FDA, Dr. Crawford directed that a review of all current outside activity requests from FDA employees be conducted. The purpose of the review was to assess compliance with the Agency's strict ethical standards as well as with the standards established by the Office of Government Ethics' Standards of Ethical Conduct and DHHS and FDA Supplemental Standards of Ethical Conduct Regulations, and to assure that the outside activities undertaken by FDA employees are in the public interest.

A team comprised of Jeffrey M. Weber, Associate Commissioner for Management and FDA's Deputy Ethics Counselor; Dr. Norris Alderson, Associate Commissioner for Science; Kimberly Holden, Director, Office of Management Programs; and Jenny Slaughter, Director, Ethics and Integrity Staff, were tasked with conducting the review and reporting their findings.

The review covered more than 1,800 HHS Form 520's, "Request for Approval of Outside Activity" for both paid and unpaid work FDA employees perform outside of their official duties.

"This review shows that the aggressive disclosure and review process designed to prevent conflicts of interest is working well," said Dr. Crawford. As a public health and regulatory agency, FDA has consistently lived up to the highest ethical standards. 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."

In addition to requiring the director of each product-based FDA center to personally review all requests for outside activities, a new safeguard announced last month, FDA today is taking several additional steps to protect against potential conflicts-of-interest:

• Expanding the number of FDA employees required to file declarations of their financial holdings. For example, although previously only FDA non-administrative employees at the GS-14 level and above had to file, now GS-13 non-administrative employees will be included as well.
• Announcing that it will conduct an annual review of outside activities, linking each outside activity to financial disclosure statements. In the current dynamic environment, an annual review offers better protection against conflicts of interest.
• Issuing an agency-wide “Staff Manual Guide” on outside activities, to ensure uniform practices across the board.
• Developing an electronic version of the new expanded HHS Form 520, which will allow more rapid and systematic analysis of outside activities.

The review did not identify any additional cases of an approved outside activity for a covered employee that could pose a concern, beyond the one instance identified recently regarding the work of an employee of FDA's Center for Biologics Evaluation and Research (CBER). A previous FDA review of Form 520s had discovered that the CBER employee's request should not have been approved. Early last month the CBER employee was informed that his outside activity was no longer approved, and the employee voluntarily agreed to sever the relationship.

Today's new measures will go into effect as soon as possible.