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Generics Manufacturers Not Liable for the Design of Drugs

In the case of Mutual Pharmaceutical Co. Inc. v. Bartlett, the Supreme Court overturned a lower court ruling that awarded a New Hampshire woman a sizeable amount of money for damages suffered as a result of taking a generic medication.  The court’s majority opinion outlined that the generics manufacturer had no way to comply with the New Hampshire law to design products that are not “reasonably dangerous,” as generics companies are not allowed to change the chemical makeup of the drug or change the warning label.  This ruling, combined with a ruling from 2011, prevents consumers from suing generics companies for defective drug design and failure to warn, as long as the warning label reflects that of the innovator company’s predecessor drug.

The President and CEO of the Generics Pharmaceutical Association (GPhA) supported the decision, as it leaves safety and efficacy decisions with the “scientific experts at the Food and Drug Administration (FDA).”  Dissent for the ruling came from two Justices and consumer advocate groups.  Justice Sotomayor implied that this petitioner was “deprived of remedy.”  Consumer advocate groups point to the limited recourse that consumers have in these situations, though courts in Vermont, California and Alabama have allowed consumers to sue the branded manufacturer of the drug to seek compensation.

These events prompted the Food and Drug Administration (FDA) to consider a proposed new rule to allow generics companies to make changes to the label to reflect new information, like safety concerns.  Today, label changes typically come when branded manufacturers request label changes with the FDA; then, generics companies follow suit. Under this new proposed rule, generics companies could also make label changes following a similar process.

This new rule could be a solution to both better inform consumers of risks and “create parity” between branded and generic drug companies from a packaging and labeling standpoint – something that will certainly become more front and center as industry and the FDA move closer to adopting a pathway for biosimilars.  Without clear processes and monitoring, though, the market could end up with multiple labels for the same drug, causing consumers’ confusion.  And, of course, with “privilege” comes responsibility – if these changes are made, generic drug companies will need to be able to flex and adjust in new and different ways than they have had to in the past, to be able to approve and disseminate label changes through the supply chain.

Tags: Strategy & Compliance