Almost a year ago, I eagerly wrote about the FDA’s proposed rule that would permit generic drug manufacturers to unilaterally change the warnings on their product labels, effectively overturning the Supreme Court’s decision in PLIVA v. Mensing. Currently, a generic drug manufacturer cannot update its warning label but instead must make sure it mirrors that of the brand name drug. Because they cannot update the warnings, they are shielded from legal liability for injuries the drug may cause in most instances. The FDA’s proposed rule aims to fix this. It allows generic drug manufacturers to initiate a label change on their own, and therefore exposes them to legal liability for failing to do so when additional risks or complications associated with the drug become known to the manufacturer. As to be expected, this rule was met with sharp criticism and opposition, particularly from the generic pharmaceutical community. A year later, the new rule has yet to be published and it appears that there is still a significant uphill battle to fight before it is finalized (and even after).
Recently, the Generic Pharmaceutical Association (GPhA) threatened to file a lawsuit should the FDA publish the new rule, in an effort to seek some kind of compromise and prevent generic manufacturers from having the responsibility to update their product warning labels. In support of its potential lawsuit, the GPhA argues that the FDA does not have the legal authority to implement this rule because it contradicts the “sameness requirement” of the Hatch-Waxman Act. The Hatch-Waxman Act is a federal law that requires generic drug labels to match those of their brand name counterpart. This argument has been made by those in opposition to this rule since its introduction. The GPhA does indicate that it is willing to compromise on changes to the rule, but cannot support it in its current state.
Generic manufacturers strongly oppose the rule, claiming that the cost of litigation would increase so substantially that it would cause generic drug prices to skyrocket. This would be a significant hit to consumers who currently benefit greatly from accessible and affordable generic drugs. From my perspective, this position does not take into account the need to incentivize consumer safety or the need to protect consumer’s rights if they do in fact become injured by the use of one of these drugs.
The FDA’s proposed rule has been criticized not only by the generic pharmaceutical community, but also by the House Appropriations Committee, who voiced skepticism of its economic impact as well as its legitimacy in light of the long-standing “sameness requirement” imposed by federal law. In the face of this opposition, the FDA continues to work towards finalization. The FDA originally projected a final rule to be published by December 2014, though it is unclear how this timeline may shift as a result of extended comment periods and the ongoing criticism. If the rule is in fact published in its current form, the fight will continue as the FDA prepares for possible litigation.
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