By Lisa Seachrist

Washington Editor

WASHINGTON * Health and Human Services Secretary Donna Shalala has handed up her recommendations for FDA commissioner to the White House, and the front-runner is Lead Deputy Commissioner Michael Friedman.

A source close to the administration told BioWorld Today that Shalala had ended her review of potential candidates for the job and the likely nominee would be current acting FDA head Friedman. It is now up to the Clinton administration to offer the nomination to the Senate.

Shalala tapped Friedman to lead the agency on an interim basis when controversial FDA Commissioner David Kessler left his post in late February to take over as Yale University's dean of medicine this summer. At that time, Shalala solicited potential candidates from industry and academia and said she would take personal responsibility for any candidates nominated.

Friedman, deputy commissioner for operations at the time, led the negotiations with industry last fall that produced an agreement for the reauthorization of the Prescription Drug and User Fee Act (PDUFA)

In January 1997, those negotiations expanded to include all of FDA reform. The consensus achieved by the agency and industry served as the basis for PDUFA provisions that Sen. Jim Jeffords (R-Vt.) included in S. 830, the FDA Modernization and Accountability Act.

As lead deputy commissioner, Friedman has led the negotiations for FDA reform, proposed pediatric testing of prescription drugs and expanded food safety initiatives.

It is unclear when the Clinton administration will officially make a nomination, but it is unlikely to happen soon. Many speculate that the nomination won't be tendered until PDUFA has been reauthorized. *