Ever since the Republican takeover of Congress in November 1994, the Food and Drug Administration has been under fire from critics on the right who claim the agency is slow to approve lifesaving drugs and medical devices. Newt Gingrich has called FDA Commissioner David Kessler "a bully and a thug." The conservative Washington Legal Foundation runs ads that say: "If the FDA kills you, it's just being cautious." Similarly, Citizens for a Sound Economy, an anti-tax group, sponsors ads claiming, "A better quality of life--even life itself--is being denied to too many Americans because of the FDA's misplaced priorities."
Meanwhile, the Competitive Enterprise Institute, a right-wing think tank, has put forward a radical plan that would end the FDA's power to veto new drugs and medical devices. Gingrich's own Progress & Freedom Foundation has likewise recommended "replacing" the FDA with a private drug-approval system. Following their lead, Republicans in both the House and Senate have introduced legislation to reduce the FDA's regulatory authority.
Yet, for the most part, these proposals are far more radical than any called for by drug and medical device manufacturers--the supposed beneficiaries of a scaled-down FDA. Tom Lenard, the Progress & Freedom Foundation's director of regulatory studies, puts it bluntly, "The drug companies are not particularly radical. Our proposal is beyond where most of them seem to want to go."
A top FDA official concurs: "The drug companies are happier than they have been in 10 years." In fact, changes instituted by Kessler over the last five years have actually cut approval time by 30 to 40 percent.
Nor are medical device manufacturers driving the attack against the federal agency. "The device industry doesn't want to see the FDA go away or be weakened," says Jim Benson, senior vice president of the Health Industry Manufacturers Association.
So where is the pressure to gut the FDA coming from? "If you look at the people who are pushing for reform of the FDA," says one FDA official, "behind the scenes you will see the tobacco industry."