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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 and the Generic Pharmaceutical Association, labeling it a disguised bid to subvert patient lawsuits.
“The industry ‘alternative’ is a transparent attempt to minimize manufacturer responsibility for postmarketing vigilance and to enjoy and extend immunity from suit,” advocacy group Public Citizen argued.
Known as Expedited Agency Review, the PhRMA-GPhA proposal would apply to products with brand-name and generic versions. It calls for all manufacturers to notify the FDA of new safety concerns and then update their labels if the agency agrees. That’s different than the current approach that has brand-name drugmakers update labels unilaterally but offers no direct route for such action by generics manufacturers.
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