In its recent decision on drug labeling, the U.S. Supreme Court prescribed a judgment that looks like bad medicine.
The court ruled in Pliva v. Mensing that the Food and Drug Administration's regulatory system pre-empts any claim in a state court that the maker of a generic drug did not adequately warn consumers of potential risks from the product. Two years ago, in Wyeth v. Levine, the court looked at a similar case but took a different approach, holding manufacturers of federally approved brand-name drugs liable for inadequate labeling. After that decision, several federal circuits extended the high court's analysis to generic manufacturers. Consistent throughout this series of cases was a reliance on the reasoning in Wyeth that denied the pre-emption defense to brand-name manufacturers: namely, that federal approval of a brand-name drug did not prevent a suit against a manufacturer in a state court.
In Pliva — which combined the cases of two separate plaintiffs who claimed they were made ill after taking a generic drug that lacked an adequate warning on its label — the Supreme Court approvingly stated the FDA's position that the "central premise of drug regulation is that the manufacturer bears responsibility for the content of its label at all times." Yet, as the court also noted in Pliva, federal regulations offer brand-name manufacturers mechanisms to alter their labels — opportunities that, it's essential to point out, are unavailable to generic-drug manufacturers.
From the federal perspective, this means generic manufacturers must maintain warning labels identical to their brand-name counterparts. If the manufacturer of a generic believes that its label is inadequate, then it is required by federal law to request that the FDA strengthen the warning on the brand-name version of the drug. State law, meanwhile, demands that generic manufacturers correct any of their inadequate labels. But as the Supreme Court ruled, generic manufacturers cannot independently alter their warning labels without violating federal regulations. The court, therefore, ruled that any state law targeting failure to put adequate warnings on labels was pre-empted by the FDA regulatory framework.
Here is where the opinion ends. But that's not the most disturbing aspect of the ruling. Rather, it is the court's action — or rather, inaction — in taking a pass on the fundamental inquiry into how generic-drug manufacturers can fulfill their responsibility to provide health care consumers and providers with accurate warning labels.
Acknowledging "the unfortunate hand [that] drug regulations have dealt" generic consumers, the Supreme Court, instead of offering meaningful guidance for a statutory scheme that would enable generic manufacturers unilaterally to meet their responsibility to address labeling concerns, has thrown up its hands, shouting "Impossible!"
There is perhaps a silver lining within the opinion. The court reminds us, "As always, Congress and the FDA retain the authority to change law and regulation if they so desire." Indeed, Washington should institute such changes as soon as possible.
What might a changed regulatory scheme look like? A new framework would provide generic manufacturers direct access to the data necessary to craft adequate labeling changes. Generic makers are currently denied direct access to the clinical-trial and post-approval data that brand-name makers use in crafting product warnings. In addition, generic manufacturers have access only to adverse-event reports related to a specific generic drug. Increasing the transparency of the process could foster open communication among generic manufacturers, their branded counterparts, and the FDA, so that warning labels reflect the most current and comprehensive knowledge available.
Without such reform, Pliva leaves health care providers and consumers subject to a bizarre statutory process that encourages brand-name manufacturers to uncover safety risks while negating traditional incentives within state laws for generic manufacturers to monitor and disclose potential dangers.
Worst of all, the consumer's right to sue over inadequate warnings hangs on a game of chance that depends on whether his or her pharmacist filled the prescription with a brand-name drug or a generic. The buyer of a brand-name drug can sue the manufacturer for inadequate warnings; the consumer of a generic product cannot.
Given that 75 percent of prescriptions are filled with generics, the public faces odds that may be hazardous to its health.
Stacey Lee, an assistant professor at the Johns Hopkins Carey Business School, teaches about legal issues in medicine and business, and researches the intersection of law, ethics and the pharmaceutical industry. Her email is firstname.lastname@example.org.