NEW DRUGS and medical devices are being kept from the public by a fussy Food & Drug Administration, say Republicans and conservative think tanks. Now, the law directs that the FDA prove that new products are safe and effective. Critics say the FDA should settle for safe in some cases, which would get life-saving products to market faster. They would leave it to consumers to find if products work.
IN REALITY, lowering the standard for approval would hurt both patients and industry. Without rigorous clinical trials showing how well a drug or device works--and how best to use it--doctors may not be able to pick the best treatment for any given condition. Consider the confusion about AIDS drugs, whose O.K.s were rushed before the usual extensive testing. To AIDS activist Gregg Gonsalves of Treatment Action Group, it's unclear if the three drugs approved to treat AIDS "are better than nothing at all." And without FDA assurance that a new drug or device does work, companies will lose a key selling point for important new products.EDITED BY LARRY LIGHT & JULIE TILSNER By John Carey