Experts Say FDA Ignored Evidence In High-Dose Aricept Review

Law360, New York (March 23, 2012, 4:26 PM EDT) -- A pair of Dartmouth Medical School professors criticized the U.S. Food and Drug Administration for approving a 23-milligram dose of Pfizer Inc.'s Alzheimer's drug Aricept, saying in a Thursday article in the British Medical Journal that the agency disregarded evidence during its review process.

Lisa M. Schwartz and Steven Woloshin said the FDA violated its own regulatory standard by approving the new dose in 2010 “over the objections of the FDA's medical and statistical reviewers,” according to a Medical News Today report. The professors said the...
To view the full article, register now.
Law360 Pro Say Podcast
Check out Law360's new podcast, Pro Say, which offers a weekly recap of both the biggest stories and hidden gems from the world of law.