The Food and Drug Administration cannot hire the necessary peopleto properly implement its mammography quality assurance program.Congress in the past has given the FDA additional duties and thenrefused to allocate funds for support of the increased
The Food and Drug Administration cannot hire the necessary peopleto properly implement its mammography quality assurance program.Congress in the past has given the FDA additional duties and thenrefused to allocate funds for support of the increased effort.This time around, however, the FDA's staffing problems originatein the executive branch.
Congress granted the FDA permission last year to hire 65 newstaff members for its newly created Division of Mammography Qualityand Radiation Programs. Expansion is now on hold because of anacross-the-board federal hiring freeze mandated by the Clintonadministration.
"It just comes and goes," said an FDA staff memberworking on the mammography QA program. "One staff meeting,we're going to hire. The next staff meeting, we're not."
In an effort to keep the program on track, administrators aretransferring personnel from other FDA programs into the new division.
"The way we are getting staff is by lateral transfer fromwithin the agency," the FDA source said.
Earlier this month, FDA officials met in Dallas with stateofficials at the Conference of Radiation Control Program Directors.The topic was the interim final regulations for implementationof the Mammography Quality Standards Act unveiled at the RadiologicalSociety of North America meeting last month by FDA CommissionerDavid Kessler (SCAN 12/15/93).
The regulations were published in the Federal Register on December21. They will be open for public comment for 60 days after publication.Relevant comments will then be integrated and the certificationregulations will become law.
State personnel will play a key role in the certification ofmammography facilities, as will private, nonprofit organizations.Together they will review clinical images, acquire reports ofphysicist surveys and report their results to the FDA. However,federal staff are needed to administer the program at headquartersand FDA field inspectors are needed to conduct annual inspectionsat mammography facilities.
The FDA's staffing problem is especially acute consideringKessler's plan, also announced at the RSNA meeting, to have allmammography facilities in the U.S. certified by October of thisyear. Even with a fully staffed program, the undertaking is ambitious.
A six-week program is being planned to train personnel to serveas inspectors. Now that state officials have been brought up tospeed on the regulations during the Dallas meeting, the next stepis to train FDA and state personnel to run the program.