HHS Proposes to Undo the Supreme Court Rulings in Pliva and Bartlett by Regulation Changes

In 2011, the Supreme Court decided PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011), which affected “75 percent of all prescription drugs dispensed in this country.”  The court held that because the FDA requires generic drug manufacturers to use the same labels and warnings as those of the name-brand manufacturer, state law claims against generic companies regarding labeling and warnings are pre-empted. Put another way, because generic drug manufacturers cannot change their labels or warnings, even if they later learn of additional risks associated with the drug, they cannot be sued on those grounds.  This “doctrine of equivalence” was codified in the Hatch-Waxman Amendments back in 1984.  

The United States Department of Health and Human Services (HHS) announced that it intends to introduce a proposed rule in September that would undo the generic “equivalence” requirement with name-brand products.   The HSS intends to propose that generic drug manufacturers be allowed to alter warnings from those of the name-brand manufacturer.

The proposed rule would amend regulations for new drug applications, abbreviated new drug application (ANDA) and biologics license applications.  The proposal would allow generic drug manufacturers to use a “changes being effected supplement,” also known as CBE, to change their labels and warnings without prior approval from the FDA.  If approved, this change would undermine the Supreme Court’s holding in PLIVA, 131 S.Ct. 2567 and Mutual Pharm. Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013), where the Court upheld the FDA’s rule that generic drug manufacturers cannot change their labels and warnings from those of the name-brand manufacturer. 

If approved, this rule would give generic drug manufacturers greater flexibility in their marketing than their name-brand competitors. That flexibility, however, is not without a cost. Generic drug companies are currently immune to product liability lawsuits arising out of labeling and warning issues because their warnings must be identical to those of the name-brand manufacturer who is subject to suit. However, once generic drug manufacturers are given the opportunity to change their labels and warnings, they are potentially open to litigation regarding the sufficiency of those labels and warnings, whether they make the changes or not.

Generic drug companies would also potentially be subject to state laws under this proposed rule, which would require them to monitor the medical literature to continually update and change their labels and warnings.  This would significantly increase the cost of generic drugs and would undermine the intention of Hatch-Waxman, which was to keep the cost of generic drugs down. 

Finally, this rule has the potential to lead to conflicting warnings and labeling regarding several products that are chemically identical. Doctors, and through them, their patients, could certainly be confused when faced with two identical pills for the same condition that have different warnings and labels. 

Click here for a link to the proposed rule.

Practical Tip:  Watch and see if the HHS takes any further steps to move this to fruition in September.  Check back here for an update.

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