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President Kennedy Signs New Drug Bill

Oct. 10, 1962 - President Kennedy signed a new drug bill today that he said would help provide safe and more effective drugs to the American people. Standing by in his White House office were legislators who had helped to pass the bill. With them was Dr. Frances O. Kelsey (second from left), the FDA medical officer whose vigorous stand prevented the introduction of the sleep-inducing drug Thalidomide on the American market. These are the measure’s basic provisions.

- The FDA will receive new powers for factory inspection and quality control. All drug manufacturers will have to register with the government.

- A new drug will have to be proved effective as well as safe, and it cannot be marketed without specific approval of the Secretary of Health, Education, and Welfare.

- The Secretary can order a drug off the market instantly if there is evidence it is unsafe.

- All antibiotics for human consumption will be tested on a batch-by-batch basis for strength and purity.

- Drug manufacturers will have to list “in brief summary” in their advertising bad side effects of any prescription drug.

- The manufacturers will have to print a common, or generic, name for a drug on the label in type at least half as large as its trade name.


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