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December 22/29, 1999

Safety of FDA-Approved Drugs—Reply

Author Affiliations

Copyright 1999 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.1999

JAMA. 1999;282(24):2297-2298. doi:10-1001/pubs.JAMA-ISSN-0098-7484-282-24-jbk1222

In Reply: Drs Lurie and Sasich express no disagreement with our primary observation: that although drugs approved for marketing sometimes are found to have serious problems after marketing, there is no evidence that there are more such occurrences now than in the past. This seemed to us to provide tangible evidence (together with our knowledge of our own standards) that the FDA had not lowered its review standards. The central conclusion of our article was that despite a substantial increase in the number of new products approved for marketing over the last decade, there has been no increase in the rate—or even in the number—of drugs removed from the market because of subsequently discovered safety problems.