Disillusionment at FDA

Just as physicians were building a fire under FDA to speed approval of one new drug (see above], a doctor on the agency's own staff raked it over the coals for having approved too many drugs too fast. Pediatrician John O. Nestor, 50, joined FDA's New Drug Division two years ago because he thought it was underestimating the hazards to infants and children of drugs that might be safe enough for adults. Dr. Nestor was so disillusioned by what he saw of FDA's operations that last week he appeared before Senator Hubert Humphrey's Government-operations subcommittee and charged that:

P: At least three drugs were approved for sale even though the manufacturers had insufficient evidence of their safety.

P: Two of them were left on the market for months after signs of danger appeared.

P: At least one drug was approved although some of the evidence in its favor came from a medical investigator suspected of supplying "questionable data.''

P: Medical men in FDA were overruled by nonmedical bureaucrats.

FDA Commissioner George Larrick retorted that most of the drugs about which Dr. Nestor complained are now off the market. If they are not, last year's Drug Amendments Act, which goes into full effect in May, gives the FDA power to order withdrawals promptly without waiting for final proof of a drug's suspected dangers.

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