“This marks the third time that FDA has delayed finalizing its controversial labeling rule and may signal that FDA is considering abandoning the rule. That would be good news for consumers, whose safety could be placed at risk by a proposed rule whose only purpose is to placate the plaintiffs’ bar.”
—Richard Samp, WLF Chief Counsel
WASHINGTON, DC— The Food and Drug Administration (FDA) announced this week, without further explanation, that it has postponed adopting (until at least April 2017) its controversial proposed rule that would permit generic drug companies to make unilateral changes to their product labeling. FDA’s decision to postpone final action on the proposed rule until after the presidential election marked a victory for Washington Legal Foundation (WLF), which has repeatedly urged FDA to abandon the rule. WLF has called on FDA to adopt the Expedited Agency Review (“EAR”) proposal submitted by several pharmaceutical industry trade groups, in lieu of FDA’s own labeling proposal. In three separate formal comments submitted to the agency over the past two years, WLF argued that the EAR proposal ensures that new safety information about FDA-approved drugs reaches doctors and consumers much more quickly than under the labeling regulations proposed by FDA.
Under current law, generic drug companies must ensure that the labels of their products are identical to the labels of the brand-name drugs they emulate. In light of that “sameness” requirement, generic companies are not permitted to make unilateral changes in their product labels. If they discover new safety information that they believe should be brought to the attention of doctors, they may submit that information to FDA but must await FDA approval before making changes. FDA’s proposal would permit generic companies to revise their labels unilaterally while they await word regarding whether FDA approves the change.
WLF argues that the chief result of FDA’s proposal would be consumer confusion, brought on because different versions of the same drug would bear conflicting safety warnings. WLF notes that the proposal includes no mechanism for early resolution of the conflicts.
Following FDA’s decision yet again to postpone final action, WLF issued the following statement by Chief Counsel Samp: “This marks the third time that FDA has delayed finalizing its controversial labeling rule and may signal that FDA is considering abandoning the rule. That would be good news for consumers, whose safety could be placed at risk by a proposed rule whose only purpose is to placate the plaintiffs’ bar. Lawyers love the rule because it would make it much easier for them to file products liability lawsuits against drug manufacturers. If generics are permitted to change their labels unilaterally, they can be sued for failing to do so.”
WLF is a public interest law firm and policy center that seeks to ensure that economic liberty is not impeded by excessive litigation.