James Goddard; improved drug testing as FDA leader

JAMES GODDARD JAMES GODDARD (George Tames/ New York Times)
By Douglas Martin
New York Times / January 4, 2010

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NEW YORK - Dr. James L. Goddard, who as a crusading commissioner of the Food and Drug Administration in the 1960s helped revolutionize the federal government’s methods of evaluating drugs, died Dec. 18 in Laguna Woods, Calif. He was 86.

His son, Bruce, said the cause was a brain hemorrhage.

From 1966 to 1968, Dr. Goddard, serving under President Lyndon B. Johnson, strove to put the FDA on a sounder scientific footing to better serve the consumer.

He cracked down on exaggerated drug advertising and delayed approval of new drug applications until manufacturers had backed them up with more laboratory and clinical testing. And he campaigned to take ineffective drugs off the market.

The New York Times Magazine called him “a wild-eyed crusader with a battle-ax flailing boldly.’’

Several months after he assumed leadership of the agency, Dr. Goddard spoke to pharmaceutical executives and suggested that many were dishonest in their applications for new drugs. He said the industry might be “altered beyond your present fear.’’

“If this sounds alarming,’’ he said, “it is because, frankly, I am alarmed.’’ The effect was to push the FDA into a new era.

“James Goddard marks the demarcation between the old FDA - that had no MDs, no strong standards of evidence, and largely subservient relations with the pharmaceutical industry - and the new FDA that was headed by an energetic doctor, enforced strong standards of evidence, and became an advocate for the public’s health,’’ said Philip J. Hilts, a journalist.

Hilts, author of “Protecting America’s Health: The FDA, Business and One Hundred Years of Regulation,’’ called Dr. Goddard one of the three or four best commissioners in the history of the agency.

In one instance Dr. Goddard wrote and put into effect legislation calling for drugs to be tested for efficacy as well as for safety. The law, enacted by Congress in 1962, mandated scientific testing of all new drugs to see whether they worked, as well as testing of drugs introduced before 1962 for both safety and efficacy.

Dr. Goddard banned 250 antibiotic preparations, particularly throat lozenges, from the market because drug makers had not proved their effectiveness. He started an investigation of possible criminal violations in the testing of new drugs.

He also wanted to test drugs against one another to make sure that any new drug functioned better than ones already approved. For political and economic reasons, Hilts said, the proposal never gained traction.

James Lee Goddard was born in Alliance, Ohio, served in the Army during World War II, and completed his medical degree at George Washington University in 1949. After briefly practicing medicine, he joined the Public Health Service in 1951, interrupting this work to earn a master’s degree in public health from Harvard in 1955.

In 1962, he was named assistant surgeon general and chief of what was to become the Communicable Disease Center (now the Centers for Disease Control and Prevention in Atlanta). At 39, he was its youngest chief ever.

In August 1965, John W. Gardner, secretary of health, education, and welfare, set up an advisory committee to reorganize the FDA, where morale was low. He picked Dr. Goddard to lead the effort in 1965, and he became commissioner of the agency the next year. He decided that Dr. Goddard should lead the way. Dr. Goddard accepted, even though he had made it clear that he wanted to be surgeon general.