Under FDA regulations, generic drugs must be chemically equivalent, have the same active ingredients, and be bioequivalent to their branded counterparts. However, while a branded drug manufacturer is responsible for the accuracy and adequacy of its drug label, a generic drug company is responsible for ensuring that its warning label is the same as the label of the brand-name reference listed drug (RLD). Some argue that this “sameness” requirement could put consumers’ health at risk given that new drug safety issues are often not discovered until after a new drug has been sold to the public, or sometimes even after the branded drug is off the market. But the regulatory framework and law in the United States has not fully kept up with the rate of innovation.
Supreme Court Blocks State Claims Against Generic Drug Companies For Inadequate Safety Labeling
Despite the “sameness” requirement, consumers have attempted to sue generic manufacturers on state-law claims. However, the United States Supreme Court has held that these state claims are preempted by federal law. In 2011, the Supreme Court ruled in PLIVA v. Mensing that failure-to-warn state law claims against generic manufacturers were preempted by the FDA’s prohibition on changes to generic drug labels. The Court acknowledged that it “makes little sense” to bar state law-based suits against generic drug makers (while allowing the same exact claims to proceed against the brand name entities), but added that its duty was not “to decide whether the statutory scheme established by Congress is unusual or even bizarre.” Two years after PLIVA, the Supreme Court decided another case involving allegations of inadequate generic drug labeling. While acknowledging that the plaintiff, who suffered extreme injuries from her use of the generic drug, had a case that was “tragic and evoke[d] deep sympathy,” the Supreme Court overturned the verdict awarding her $21 million for her state law design- defect claim, finding that “it was impossible for Mutual to comply with both its state-law duty to strengthen the warnings on sulindac’s label and its federal-law duty not to alter sulindac’s label.”
FDA’s Efforts To “Create Parity” Between Generic and Branded Drug Makers Are Challenged and Delayed
In November 2013, largely in response to the Supreme Court decisions in PLIVA and Bartlett, the FDA proposed a rule that would require generic drug companies to submit, like brand name drug makers, a “changes being effected” (CBE-0) supplement to revise labeling of generic drugs. A CBE-0 supplement would serve to reflect and distribute new safety information in advance of the FDA’s review of the labeling change, regardless of whether the revised labeling differs from the RLD labeling.
The FDA’s proposed rule came quickly under scrutiny. Some pointed out that the new rule would run contrary to the law’s requirement that a generic drug have labeling that “is the same as the labeling approved for the listed drug.” Another criticism of the proposed rule is that it could result in a situation where the warning label for a generic version of a drug differs in material respects from the warning label for the same, bioequivalent branded drug. In addition, the Generic Pharmaceutical Association (GPHA) has argued that the new rule could increase product liability litigation to such an extent that consumer spending on generic drugs would increase by $4 billion. The FDA has delayed finalization of the rule until late 2015.
In light of the protection that the law’s sameness requirement currently affords to generic drug makers for mislabeled or inadequately labeled generic drugs, plaintiffs’ lawyers have also attempted to bring suit against the brand name drug manufacturers — even when the underlying injury resulted from consumption of the generic, rather than the branded version of a given drug. However, the majority of these claims have been rejected by courts across the country.
The Effect on Consumers
Where does this all leave consumers of generic drugs who suffer injuries as a result of inadequate drug safety labels?
- First, consumers have limited recourse against generic drug manufacturers since federal law requires generic drug makers labels to mimic branded drug maker labels.
- Second, while some generic labeling consumer claims against branded drug makers may be successful, those cases are rare.
- Third, the FDA’s proposed new rule on generic labeling faces significant hurdles, including both substantive and economically-based criticisms. As a result, the regulatory path to promoting consumer safety remains fraught with uncertainty.