FDA ends hiring freeze, aids mammography effort

A hiring freeze that has hobbled the Food and Drug Administrationis apparently over. The FDA Center for Devices and RadiologicalHealth is proceeding with plans to boost its staff by 300 abovethe fiscal 1993 level, according to agency sources.

"(An) increase in hiring authority will permit FDA toaddress its new statutory responsibilities under the PrescriptionDrug User Fee Act and the Mammography Quality Standards Act. Inaddition, you will be able to stop the deterioration in medicaldevice application review times," said Dr. Philip R. Lee,assistant secretary for health, in a memorandum to FDA CommissionerDavid Kessler last month.

Most directly affected will be the quality control programaimed at certifying an estimated 10,000 mammography facilitiesby Oct. 1 and the FDA's struggle to reduce the backlog of medicaldevice reviews.

The mammography program has been using lateral personnel transfersfrom within the FDA to keep on track (SCAN 1/19/94). Full-timestaff are now being hired.

Similarly, the office of device evaluation (ODE), under theleadership of acting director Dr. Susan Alpert, has drawn on stafffrom the office of science and technology (OST) to review devicesubmissions. Many of those submissions have been on hold becausereview staff were not available.

However, OST staff--on loan to the ODE only until this month--area stop-gap measure until new staff can be hired and trained totake over review tasks and whittle down the backlog. The end ofthe hiring freeze should allow the FDA finally to launch thisstage of the operation.

"OST was going to be a bridge until we could get new staffon and trained," Alpert said. "We did lose time bringingthem on, due to the freeze. But the 70 new reviewers (now beinghired) are going to help."

Lifting the hiring freeze may be the final act in a bureaucraticminidrama that began last summer when the Clinton administrationissued an order to reduce the federal work force.

The Office of Management and Budget set out to cut 225,000federal jobs over five years, with the first 100,000 to be eliminatedby 1995. Initially, it appeared that the FDA would dodge thatbullet entirely, thanks to the efforts of Rep. Richard Durbin(D-IL), chairman of the House appropriations subcommittee responsiblefor FDA funding, and Rep. John Dingell (D-MI), chairman of theCommittee on Energy and Commerce, who intervened on FDA's behalf.

Believing that the FDA was understaffed in light of the newduties it had assumed in recent years, the two members of Congresspushed through an amendment to the fiscal 1994 FDA appropriationsbill to restore the proposed increase in FDA staff.

With the amendment passed, the FDA began recruiting 150 newstaff in August, including about 75 for device review. But theeffort to spare the FDA was blunted by an edict from Lee, whoissued an employment freeze on Dec. 8 for the entire Public HealthService, of which the FDA is part.

On Jan. 11, Lee rescinded the order specifically for the FDA,allowing the agency to resume its hiring efforts.

While the addition of new reviewers will help, "It isnot going to be magic," Alpert said. "It is importantto recognize that it took several years to build the backlog andit is going to take time to clear it. But we are trying to reduceit by significant proportions."