FrontLine Security NEWS- Inside the FDA

INSIDE THE FDA:
It's almost impossible to overestimate the power of the U.S. Food & Drug Administration. Its mandate covers one-fourth of the entire American economy – from peanut butter to pacemakers, vegetables to Viagra, even cell phones and airport screening machines. Not surprisingly, with such wide-ranging power, the FDA regularly confronts some of the most controversial issues of modern society, including religious fundamentalism, the cost of health care, bioengineering of food, government deregulation, alternative medicine, and the power of Madison Avenue – in addition to trying to keep up with fast-changing scientific advances.

Because its mandate affects so many aspects of daily life, the FDA comes under tremendous, constant, and contradictory pressure from industry, consumer safety groups, patient advocates, insurance companies, doctors, religious leaders, and politicians. Pharmaceutical companies and patient groups demand that the agency approve drugs faster, to get the medications to people who desperately them. Safety groups condemn the agency for approving drugs too fast, without checking for dangerous side effects. Members of Congress react to both sides, hauling FDA officials in for questioning – while cutting the funding the agency needs to respond to those demands.

And the FDA officials themselves? By and large, the staff scientists are knowledgeable and dedicated. But the pressure gets stronger as it goes up the chain of command.

To understand how this crucial agency works, author Fran Hawthorne interviewed scores of FDA employees, industry officials, doctors, politicians, consultants, lobbyists, and other experts. Among other topics, she investigates how the religious right blocked a birth control pill – why the agency allows drug ads on TV – why it dropped the ball on regulating genetically engineered food – how dangerous drugs like Vioxx and Rezulin manage to slip past the safety review – and how the repercussions from a scandal involving Martha Stewart may make it harder for FDA scientists to keep up with new research.