Even Drug Companies Fear Its Abolition : Preserve but reform the Food and Drug Administration

Back during a previous wave of revolt against federal government regulation, when Ronald Reagan ran for President in 1980, an ideologue of the right suggested abolishing the Food and Drug Administration. He offered this free-market alternative to the rigorous and costly FDA approval process: Suppose a company sold baby food that contained toxins. After a while, enough babies would die or sicken that word would spread among parents, who would then stop buying the product. The company would go out of business.

Fortunately, the Reagan crowd was smart enough to reject such lunacy and the FDA survived.

Now comes a new assault on the FDA and its commissioner, Dr. David A. Kessler. The Speaker of the House, Newt Gingrich (R-Ga.), has called Kessler a “thug” in his dealings with drug companies, some of which have made generous contributions to Gingrich’s Progress and Freedom Foundation. Gingrich fails to mention that Kessler was appointed by President George Bush, a Republican, not the Democratic President Bill Clinton. And Gingrich has embarrassed himself by carrying water for conservative groups that claim the FDA needlessly held up approval of a Danish-made resuscitation device meant to save heart attack victims; there is no proof the device does anything special. On such a flimsy basis he calls the FDA a “job killer.”

Defenders of the FDA frequently refer back to 1961, when the agency wisely blocked the sale of a tranquilizer called Thalidomide for pregnant women. The drug was later linked to tens of thousands of hideous deformities among newborns in Europe, where drug approval was and still is easier than in the United States.

Still, it must be conceded the FDA’s procedures need modernization. It typically takes 12 years, including six years of clinical trials, before a major drug or medical device wins approval. Recognizing this, the Clinton Administration recently proposed several reforms meant to ease the burden on manufacturers. Among other things, it would allow experts outside the agency to evaluate the safety and efficacy of various low-risk medical devices before approval. This is an experimental step toward the European model, in which medical devices--everything from bandages to defibrillators--go on the market without formal government review but then are subject to withdrawal if problems develop in use.

Many manufacturers believe still bolder steps are needed. Leaders of the Pharmaceutical Research and Manufacturers of America, representing brand-name drug makers, are pressing for use of spot checks to evaluate clinical trials, to reduce the paperwork burden of the approval process.

Such ideas are worth considering, and will be by Congress. But believe it or not, there are again those who would abolish the FDA. One conservative think-tank analyst recently complained publicly that the FDA denies consumers “choice.” Who would want to choose among defibrillators during a heart attack?

Privately and often publicly, even many drug company executives are uneasy over conservative attacks on the FDA. For all its faults, the FDA does provide a solid scientific rationale for drug approvals, thereby protecting companies from litigation. No less a critic of the FDA than Alan H. Magazine, president of the Health Industry Manufacturers Assn., said recently: “We are for a strong FDA. They are our credibility.”

Congress should take heed before it undermines or dismantles such an important agency.