Word: fda
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Dates: during 1960-1969
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...industry heard such an unbridled attack as came last week from the head of the U.S. Food and Drug Administration. About 500 drug-company delegates gathered at Boca Raton, Fla., for the annual convention of the Pharmaceutical Manufacturers Association could have used some of their own tranquilizers after the FDA's new boss, Dr. James Goddard, got up to speak. He accused the industry's executives of slovenliness, deception and dishonesty-and warned them that they had better straighten up or else face much stricter controls...
Matter of Tone. After just ten weeks on the job, Goddard-the first physician in 40 years to chair the FDA-said that he had seen flagrant examples of sloppy research, improper labeling, and misleading advertising. In the area of new drugs still under investigation, he was astounded by "low-quality work" and "conscious withholding of unfavorable animal or clinical data." He had also been "shocked at the clear attempts to slip something...
...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...
...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...
...Call for certification, after FDA testing, of every batch of drugs whose potency and purity "can mean life or death to a patient...