President Trump recently announced his intent to nominate a new commissioner of the U.S. Food and Drug Administration (FDA), likely sealing the fate of FDA’s proposed generic drug labeling rule. The proposed rule would give generic drug manufacturers responsibility for maintaining the accuracy of their abbreviated new drug application (ANDA) labels, allowing them to make changes that differ from the product’s reference listed drug label and without obtaining prior FDA approval. While proponents of the rule argue that it promotes patient health and safety, those in the industry have strongly opposed the rule, recognizing that it would result in conflicting labels, thereby likely opening the floodgates to failure to warn litigation based on conflicting labels.
The proposed rule, which has received enormous pushback and delay, appears even less likely to survive in light of Trump’s nominee for FDA commissioner, Scott Gottlieb. Gottlieb previously served as a deputy commissioner at the FDA and has been vocal in opposing the proposed labeling rule. He argues that the rule would increase healthcare costs and expose generic drug manufacturers to failure to warn lawsuits. The rule has faced numerous delays since it was first proposed in 2013, and is unlikely to be finalized in April as currently scheduled. If confirmed by the Senate, Gottlieb will almost certainly attempt to halt the rule.
For more information about the proposed rule and a related FDA draft guidance, see our prior client alert.