On May 19th, the FDA again postponed publication of the Final Rule entitled, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products” to April 2017 (the “Final Rule”). On May 19th, the House of Representatives Committee on Appropriations approved the 2017 Agriculture Appropriations bill, which includes provisions within Section 747 expressly defunding any efforts by the FDA to enact the rule. The Notice of Proposed Rule-Making (“NPRM”) was originally published in November 2013 to provide generic drug and biologics manufacturers with the ability to update safety information on their labels independently of the brand manufacturer.
The proposed rule was published in response to the decision by the Supreme Court of the United States in the case of PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), which held that generic drug manufacturers cannot be held liable for failure to update the safety label of a drug or biologic in violation of state “failure to warn” tort law. FDA regulations currently require that the label of a generic drug must match the wording of the label of the corresponding name brand drug. The Court found that, under its reading of those regulations, the generic manufacturer could not unilaterally update the generic drug’s label without violating these regulations. As such, the Court held that FDA regulations preempt state tort law with regard to such failure to warn claims such that the generic manufacturer cannot be held liable for any failure to update the label except to match the label of the corresponding brand drug.
The goal of the proposed rule is to allow certain generic drug or biologics manufacturers to update the label of the generic drug or biologic upon receipt of new safety information and with notice to the FDA. The proposed rule would not require, under certain circumstances and for limited durations, the generic label to match the label of the brand drug; however, it would require generic manufacturers to review and monitor safety information and scientific literature regarding its drugs in the same manner as brand manufacturers must monitor and review information about their marketed compounds and biologics. Adoption of the proposed rule would likely give state courts the freedom to impose liability upon generic manufacturers for failure-to-warn claims given that the rule would undercut the basic premise of the Supreme Court’s holding in PLIVA, Inc. v. Mensing.
This is the second time the Final Rule has been postponed. The FDA originally closed notice and comment on March 13th, 2014 with a projected publication date for the Final Rule in September 2015. Rather than issue the Final Rule, the FDA reopened the comment period in February 2015, held a one day public meeting, and revised the anticipated publication date of the Final Rule to the Spring of 2016. While the NPRM was originally meant to quell public outcry over the Supreme Court’s decision not to hold generic manufacturers liable for the labeling of their drugs, the proposed rule has caused possibly even greater controversy. Trade groups for generic manufacturers opposed the original NPRM and continue to oppose any efforts to finalize the proposed rule. Now that the House of Representatives has passed its appropriations bill the possibility that the proposed rule may be abandoned altogether is becoming more likely.