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FDA May Drop Generic Liability Shield, Allow ANDA Manufacturers To Change Labels

 
• By Brenda Sandburg

Solicitor General notes that FDA is considering changing its regulations in an amicus brief in Mutual Pharmaceutical v. Bartlett; government says design defect claims against generic manufacturers are preempted by federal law in the case at hand but may be brought in other situations.

FDA is considering changing its regulations to allow generic manufacturers, like brand name manufacturers, to change their labeling “in appropriate circumstances,” the Solicitor General notes in an amicus brief in Mutual Pharmaceutical Co. Inc. v. Bartlett.

Solicitor General Donald Verrilli Jr. says in a footnote that his office has been informed that FDA is considering this regulatory change. It could have enormous implications for generic manufacturers...

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