Sunday, November 30, 2014

Update on Generics, Labeling, and Liability

I began this blog back in February of 2014 with two posts on the FDA’s proposed changes to the rules for generic labeling and the issue of potential liability of generic drug manufacturers for failing to strengthen their warnings when it would be appropriate to do so. Recent events related to generic labeling and liability warrant a brief update on the issue. In litigation over injuries allegedly attributable to Reglan and its generic form, metoclopramide, a New Jersey appellate court has ruled that generic manufacturers could be liable for failure to warn when they had failed to update the label for their drugs even after the brand name manufacturer had added a new warning.  In other words, the New Jersey court held that actions for failure to warn were not preempted under the rule in Pliva v. Mensing, because in Pliva the defendants were required to adhere to the brand name drug’s label and in the case of metoclopramide the problem was the failure of some generic manufacturers to update their labels when changes were made to the brand name label.   

The second development on this issue is the news that the FDA is postponing action to finalize the proposed rule.  The FDA’s postponement of its final action on the rule comes in the wake of an interview with Regulatory Focus in which Ralph Neas, the President of the Generic Pharmaceutical Manufacturers’ Association, said that the Association was readying a lawsuit if the FDA adopted the proposed rule. The FDA has only said that it had received a very large number of comments on the proposed rule and that the Agency is committed to giving all comments serious consideration. This issue remains a hot one and the recent change in the balance of power in Washington only raises the temperature further.   

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