FDA Withdraws Proposed Rule for Generic Manufacturers

In a major development in the pharmaceutical industry, the FDA recently announced that it is withdrawing a proposed rule requiring generic drug manufacturers to independently update their drug labels with new information. Currently, generic manufacturers who hold Abbreviated New Drug Application (ANDA) are prohibited from making unilateral changes to their label prior to the corresponding branded Referenced Listed Drug (RLD) manufacturers make changes in the brand drug label. The proposed rule comprised onerous requirements for the generic manufacturers including, inter alia, mandatory reporting of newly acquired information, sending out a “Dear Health Care Provider” letters, presenting the changes in the “structured product labeling” format for FDA to avail the warnings online, and notifying branded RLD manufacturers in writing of the proposed changes.

Further, the proposed rule may have exposed generic manufacturers to product liability lawsuit stemming from a claim of failure to timely warn physicians of adverse events despite the current preemption defenses available for generic manufacturers originated in PLIVA v. Mensing in 2011 and Mutual Pharmaceutical v. Bartlett in 2013. However, it should be noted that the United States Supreme Court has accepted to review Merck Sharp & Dohme Corp. v. Albrecht, an appeal from the Third Circuit Court of Appeals’ decision in In re Fosamax (Alendronate Sodium) Products Liability Litigation. The crux of the issue being presented to the Supreme Court is whether a state law failure-to-warn claim is preempted where the FDA has rejected a drug manufacturer’s proposed label warning about the health risks at issue and whether a jury, as opposed to the trial court, may be asked to look beyond the FDA’s rejection and decide if the FDA would have approved a different warning had it been proposed by the manufacturer. The Supreme Court’s analysis will reshape the way courts around the country decide whether and how the decisions of regulatory agencies would be interpreted. 

The FDA withdrew the proposed rule given the concerns among the generic manufacturers and based their decision in the best interest of public health. Additionally, the FDA has indicated that it will continue to pursue its efforts to ensure that generic labels are contain accurate and up-to-date information throughout the lifecycle of a particular drug. 

Contact Frier Levitt today to speak to an attorney about this and other current FDA policies and regulations.