Amid New Responsibilities, FDA Faces Growing Attacks
The Food and Drug Administration oversees a broad range of consumer goods, from cabbages to cosmetics, from pills to pacemakers. That range has grown even broader recently with the soaring use of complex new drugs like antidepressants, with strange microbes entering the country on the coattails of international trade and with expanding oversight of tobacco.
The government’s logical response should be to increase FDA funding and authority, but President Clinton instead proposed an 8% reduction in funding. Even worse, the Senate is close to passing an FDA “modernization” bill that would dramatically undercut the agency. Legislation to be introduced in the House shortly is expected to be at least as bad.
The FDA’s mandate, established in 1931, is to protect national health by ensuring that foods are safe, drugs safe and effective, cosmetics harmless and products honestly labeled. To continue proper oversight, the agency needs more tools: the ability to subpoena documents regarding safety data, recall products and levy penalties against those who flagrantly violate its rules. With the giant drug and medical device companies intensely lobbying Congress, however, it will take a miracle just to protect the FDA’s current turf.
Chief among the problems of the Senate bill is its loosening of drug safety rules. The FDA currently must review two scientific studies of a drug before it can give approval. Manufac- turers also must eventually complete studies of potentially lifesaving drugs that are “fast-tracked” onto the market after preliminary research. The bill, sponsored by Sen. James M. Jeffords (R-Vt.), would let the FDA use just one study in some cases and lift the mandate that companies complete studies of certain drugs once they are on the market. At the same time, the bill would severely restrict states from regulating cosmetics. These provisions are inimical to the public health.
The Senate would give even more freedom to manufacturers of medical devices. In 1990, after nearly 1,000 deaths were caused by fractures in artificial heart valves, the manufacturer could not trace up to half of the valves. Congress then required companies to track and survey all implantable devices. The new Senate bill would require the FDA to order such tracking on a case-by-case basis.
Many of the legislators now intent on gutting the agency’s authority say they wish to encourage the economic health of industries like medical device manufacturing, in which annual revenues now exceed $50 billion. But even if regulation did hurt profit margins, safety should come first.
American medical products are highly profitable largely because the FDA has kept a sharp eye on them, building national and global trust. The inevitable scandals that will occur if oversight is relaxed can only damage both medical industries and the public.