Support for a Shake-Up

Behind his back they call him "GoGo" Goddard, and the nickname becomes more appropriate every day. Since Dr. James Lee Goddard, 42, took over as Commissioner of the U.S. Food and Drug Administration early in January, both the agency and the pharmaceutical industry have been rocked by swift and decisive actions designed to give the public greater protection against possibly dangerous drugs. Last week Dr. Goddard was not only on the go with a top-level personnel shake-up but also won a forthright declaration of the President's support.

Underlying the drastic change at FDA was an argument over policy. For two years, the agency's top medical man was the head of the Bureau of Medicine, Dr. Joseph F. Sadusk Jr., 56, a seasoned physician with a knack for getting along with other physicians. But Goddard himself is a physician, and last week he declared: "Dr. Sadusk and I are at opposite poles in philosophy. He feels that the practicing physician is best equipped to make decisions regarding the use of a drug. I feel that the judgment can be better made by a small group of specialists."

Herculean Check. Acting on the advice of such specialists and on his own preferences, Goddard brusquely reversed Sadusk in a drumfire series of decisions which drastically restricted the use of long-acting sulfa drugs, attacked the inflated advertising for Peritrate (a painkiller for angina pectoris), and flatly forbade the further manufacture of over-the-counter throat lozenges containing antibiotics. He also promised a congressional committee that FDA would promptly tackle the herculean task of checking the efficacy of 3,000 drugs marketed between 1938 and 1962.

To get the manpower for this job, Dr. Goddard borrowed 50 to 75 physicians and an equal number of pharmacologists from the U.S. Public Health Service, a sister agency with which the FDA has hitherto maintained a sterile sibling rivalry. The new FDA head also decided to break down the Sadusk system of having one team of FDA experts, headed by Dr. Frances O. Kelsey, keep track of new drugs under investigation, and a separate team decide when these drugs should be approved for general prescription use. All this was too much for Dr. Sadusk. Last week he precipitately quit, as did his No. 2, Dr. Joseph Pisani. To replace Sadusk temporarily, Dr. Goddard named Dr. Robert Robinson, 46, a Negro who had been two rungs down the bureaucratic ladder.

Kiddies' Aspirin. Critics who thought that Goddard was going too far too fast, and was likely to have higher authority slam on the brakes, were disabused of that notion by President Johnson's message to Congress on consumer interests. The President said he had appointed Goddard to give the agency "new leadership and new direction [and] a new structure fitted to the demands of the times."

Obviously reflecting Goddard's thinking, the President asked Congress to:

> Limit the number of children's candy-flavored aspirin in a single package, in the hope that even if a youngster gobbled a whole bottleful the effects would not be fatal.

> Require certain patent drugs "attractive to children" to have safety-closure caps.

> Call for certification, after FDA testing, of every batch of drugs whose potency and purity "can mean life or death to a patient."

> Control the distribution of unsolicited drug samples, some of which are sold by unscrupulous physicians or sal vaged from trash baskets in medical buildings and sold to grey-market jobbers for repackaging.

Drug safety, said the President, has the highest priority. And he added an ominous warning: "Further action may be necessary to protect the consumer against harmful cosmetics and against medical devices that are neither safe nor effective." Even Go-Go Goddard could hardly have asked for stronger backing.

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