Phil B.FontanarosaMD, Interim CoeditorIndividualAuthorMargaret A.WinkerMD, Deputy EditorIndividualAuthorStephenLurieMD PhD, Fishbein FellowIndividualAuthor
Copyright 1999 American Medical Association. All Rights Reserved.
Applicable FARS/DFARS Restrictions Apply to Government Use.1999
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.
Friedman MA, Woodcock J, Lumpkin MM, Shuren JE, Hass AE, Thompson LJ. Safety of FDA-Approved Drugs—Reply. JAMA. 1999;282(24):2297-2298. doi:10-1001/pubs.JAMA-ISSN-0098-7484-282-24-jbk1222