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: