drug approval process

In his recent opinion piece published in the New York Post, ACSH friend and former trustee (and former FDA official) Dr. Henry Miller questions the FDA s decision to grant permission for expanded access to
To the Editor: Thomas J. Moore of George Washington University and Larry D. Sasich of Public Citizen's Health Research Group blame the fast track drug approval process for premature approvals and subsequent adverse drug reactions (front page, June 23). In fact the painkiller Duract, now withdrawn, would have been approved even under the old guidelines. That the drug caused 12 episodes of liver failure out of 2.5 million prescriptions should not be a cause for alarm that the Food and Drug Administration.is not doing an adequate job of evaluating the monitoring of new drugs. To the contrary, that only six drugs have been withdrawn after marketing despite the explosion of new drugs developed and released in this decade should reassure us that our pharmacopeia is safe.
To the Editor: Thomas J. Moore of George Washington University and Larry D. Sasich of Public Citizen's Health Research Group blame the fast track drug approval process for premature approvals and subsequent adverse drug reactions (front page, June 23). In fact the painkiller Duract, now withdrawn, would have been approved even under the old guidelines. That the drug caused 12 episodes of liver failure out of 2.5 million prescriptions should not be a cause for alarm that the Food and Drug Administration.is not doing an adequate job of evaluating the monitoring of new drugs. To the contrary, that only six drugs have been withdrawn after marketing despite the explosion of new drugs developed and released in this decade should reassure us that our pharmacopeia is safe.