Critics Rip Big Pharma Alternative To FDA Warning Label Plan
Law360, New York (April 29, 2015, 3:45 PM EDT) -- An industry-backed alternative to the U.S. Food and Drug Administration’s plan to let generic-drug makers unilaterally update their warning labels is a ruse to expand immunity from product liability suits, consumer advocates and plaintiffs' lawyers charged in letters released Tuesday.
The letters were posted online after a deadline passed to comment on the FDA’s plan, which would effectively undo the 2011 U.S. Supreme Court decision in Pliva v. Mensing that shielded generic-drug firms from failure-to-warn liability. A number of prominent groups and law firms took issue with an alternative to that plan being pushed by Pharmaceutical Research and Manufacturers of America...
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