Simultaneous with the Congressional push to place regulatory authority over tobacco products with the FDA, there is growing public debate regarding the agency’s numerous problems. A chilling new report commissioned by the FDA’s own advisory Science Board outlines an organization nearly out of control, reports the Reader’s Digest special report, “Crisis in the FDA,” in the April issue.

"Think your pacemaker, heart valve, microwave oven or morning vitamin was inspected?” says former FDA Associate Commissioner William Hubbard. “Dream on.”

While journalists have long reported one shocking story after another about FDA regulatory lapses and mistakes, it is now the nation’s top doctors, scientists and lawmakers who are saying that the federal agency is in crisis. The 102-year-old agency is “woefully underfunded, dangerously understaffed and fractured by bitter internal tensions,” writes the Digest.

Increasing concerns about the safety of Chinese-made drugs have even the agency’s champions worried. “I don’t think the FDA is at a collapse point yet, but it’s getting close,” says Hubbard, who retired in 2005 after 26 years with the agency. “In some places, regulation is so weak that there’s nothing left.”

Perhaps most shocking is the fact that the FDA is tasked with regulating $1.5 trillion in food, drugs, vaccines, medical devices, blood and tissues, radiation-emitting machines, animal feeds and drugs, cell phones, dietary supplements, biotechnology and gene therapy with an annual budget of $2 billion -- a budget similar in size to that of Virginia’s Fairfax County Public Schools

What’s being done? Congress has slightly increased the FDA’s drug safety budget and has authorized the FDA to spend $25 million from user fees to improve drug safety. To address antiquated record keeping and a partially computerized database, Congress has instructed the agency to invest several million dollars to connect to large medical-records databases run by the Veterans Health Administration, Medicare and HMOs.

Last year, Congress created the Office of Chief Scientist of the FDA to provide staff members a forum for debates and improve the quality of research. At the same time, Congress moved to cut by 25% the number of advisory committee members with financial ties to a product under review – but consumer groups had sought an outright ban.