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Is the Food and Drug Administration ""an automatic approval mechanism for the drugs industry wants,"" as consumer advocates claim, or does it ""use caution and delay as substitutes for expertise and scientific judgment,"" as Senator Kennedy says. The authors think there is truth in both views. Their measured account is a sobering indictment of the pitfalls that beset ""the system."" The FDA is an adversary agency, empowered to turn down new drug applications, which adopts the attitude, ""Give me good reasons why I should not say no."" Those who can are giants promoting new drugs for profit. The consequences of the system are delays, higher costs, little incentive to develop drugs for minor or rare disorders, and occasionally, fraud and ghastly mistakes. It is the sins of omission that the authors highlight. There are drugs that have been used abroad with success, some with serious side effects, others relatively harmless. They are either unobtainable here, are still being tested, or have only limited status as investigational drugs. Minoxidil and propranolol for hypertension, beclomethasone (a topical steroid) for asthma, carbenoxolone for peptic ulcers, and verapamil for heart arrhythmias are a few the authors cite. They also indicate the loopholes by which the savvy practitioner can circumvent the regulations. To avoid this muddle they recommend that an advocate rather than an adversary agency be set up, one that could take positive action. Their recommendations need a firmer shoring up, but their main point has been to describe the impediments to the use Of potent drugs and this they have done admirably, without sensationalism, promise of cure, or panacea.

Pub Date: Nov. 1st, 1976
Publisher: Stein & Day