After several years of delay, FDA announced this summer that it expects to publish new rules in April 2017 that will permit generic drug companies to make unilateral changes to their warning labels, even if the brand does not.  The rule changes, if implemented, would have a significant impact on the potential liability of generic drug manufacturers in product liability cases.  The proposed rule changes are being met with significant opposition from trade groups for generic manufacturers.

Currently, federal regulations generally require generic drug companies to match the labels of their brand-name counterparts. As a result, it is difficult to establish generic drug product liability based on failure to warn.  The new rules would incentivize generics to be proactive in updating their warnings, as they would face a greater likelihood of liability if there is a deficiency in their labels.

The Supreme Court’s landmark decision in Pliva, Inc. v. Mensing, 564 U.S. 604 (2011) effectively immunized generic drug companies from product liability claims based on failure to warn.  The Court held that state law product liability claims against generic drug companies for failure to provide proper warnings on their labels are preempted by federal law requiring generics to have the same labels as their brand-name equivalents. Since generics do not have control over what their warning labels say, they cannot be sued for failing to warn patients of potential risks associated with taking their drugs. The Court reasserted this position in the 2012 case, Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013). In that case, the Court held that state law design defect claims based on the adequacy of a drug’s warnings are likewise preempted by federal law under Pliva.

The new FDA labeling rules have been anticipated for several years.  Earlier this year, FDA released a notice that the proposed new rules will not be published until April 2017. [Office of Information and Regulatory Affairs]. This was the third time since 2013 that FDA delayed publication of the proposed new rules.

Since FDA’s new rules, if implemented, would permit generic drug manufacturers to unilaterally update their labels, even if the brand-name manufacturer does not, we expect that patients injured by a generic drug may try to sue generic drug manufacturers for failure to warn.

The new rules also would require the generic to notify the brand of any proposed label change, to provide the brand with prompt notice of any newly acquired information that may warrant a label change.  The new rules would provide parity among brands and generics, both of which would be required to update warnings on their product inserts based on new safety information.

Given FDA’s multiple delays, as well as strong opposition to the new rules from generics, it is not certain the rules will be changed.  If they are changed, they would pose significant new challenges to generic drug companies.  Generic drug companies should monitor the situation, and be proactive in evaluating whether to put in place procedures for more robust post-marketing surveillance, reporting, and evaluation of potential label changes.


*Amy Harwath contributed to this article.