Pharmaceutical Regulatory Affairs

Biography

Biography: Martha

Abstract

FDA’s proposed rule to amend the regulations would allow generic manufacturers to change their products’ labeling to reflect newly acquired safety information in advance of FDA’s review of the change; i.e. changes-being-effected (CBE-0) procedures. Currently, ANDA holders may not use the CBE-0 process to unilaterally change ANDA labeling in a manner that differs from the Reference Listed Drug (RLD). FDA’s proposal comes about, in part, because of two recent U.S. Supreme Court decisions. In 2011, in Pliva Inc. v. Mensing the Court held that injured plaintiffs’ state-law failure to warn claims against generic manufacturers are pre-empted under federal law. In 2013, in Mut. Pharm Co. Inc. v. Bartlettthe Court held that injured plaintiffs’ state-law design defect claims against generic manufacturers that turn on the adequacy of a drug’s warnings are also preempted by federal law. In the aftermath of these two decisions, consumers injured by generic drugs are left without recourse. Proponents of FDA’s proposed ruleargue that it will provide an avenue to file failure-to-warn tort claims against generic manufacturers and encouraging them to establish extensive drug safety systems to protect the public while creating parity among application holders. Opponents argue that the proposed rule violates FDAs statutory mandate, would increase generic drug prices (and potential shortages), and rather than promoting safety would lead to confusion when labeling for a generic version of a medication will not be the same as labeling for the underlying brand-name drug. The proposed rule would create a regulatory framework whereby multiple different warnings can simultaneously exist in the marketplace for multiple generic versions of a drug. Opponents also argue the billions of dollars that will be diverted to the legal system by consumer plaintiffs could better be devoted to healthcare improvements. Other advocate that in as much as an absence of evidence exists to indicate that current authority of brand manufacturers to make temporary labeling changes upon submission of a CBE-0 supplement has led to improved patient safety, the current policy should be re-evaluated. FDA may proceed with a final proposed rule, which generic manufacturers have vowed to legally challenge or legislation may be proposed.