On January 29, 2014, the Generic Pharmaceutical Association (GPhA) published a white paper, criticizing FDA’s proposed rule which would allow generic drug manufacturers to independently submit changes to their drug labeling that differ from the reference listed drug (RLD) labeling to reflect new safety information.
In the white paper, GPhA attacked the proposed rule on multiple fronts. From a legal perspective, GPhA asserted that “such a regulatory change is contrary to the clear language of the statute governing [generic drugs] that requires ‘sameness of labeling.’” GPhA also argued that permitting generic manufacturers to independently change labeling is “something the Supreme Court already stated the statute does not allow” in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011). The white paper also sharply criticizes the proposed rule from a public policy and public health standpoint. GPhA asserted that the proposed rule would lead to confusion and uncertainty for prescribers and patients alike – by allowing the same drug to have multiple, different labels conveying different safety information – and will harm rather than enhance patient safety. Moreover, it argues that the rule could have a “staggering impact on the future availability of low-cost generic drugs [and] increas[e] the number of instances during which life-saving drugs either are in short supply or are not available” and would likely result in high costs for generic drugs to counteract litigation risks and increased regulatory compliance costs.
While GPhA stated its support for modifications that would explicitly allow generic firms to actively assist FDA in its determination that a change to labeling based on new safety information is warranted and for an efficient and prompt review of such proposed changes by FDA, it denounced any process which would require submission of independent labeling changes by generic drug manufacturers. FDA has extended the comment period on the proposed rule to March 13, 2014.
The GPhA’s white paper is available here.