Barely a month after its ruling in Bruesewitz v. Wyeth, the US Supreme Court has begun to hear arguments in another case with big ramifications for drugmakers. The current case raises questions about generic-drug companies’ responsibilities and whether federal law pre-empts state regulations, among other issues.
In 2001, Gladys Mensing began taking metoproclamide, a generic version of Reglan, to treat a stomach disorder. No branded versions of the drug had been available since the mid 1980s. After taking metoproclamide for four years, Mensing experienced early symptoms of tardive dyskinesia, an untreatable neurological disease. She no longer can live independently or control the muscles in her tongue, face, arms, and legs.
When Mensing began taking metoproclamide, the generic drug’s label matched that of the branded manufacturer. In 2009, FDA required generic manufacturers to include a warning that long-term use of the drug carried a 20% risk of causing tardive dyskinesia. Mensing’s lawyers argue that medical studies had identified this risk well before 2001, when she began taking the drug, but that generic manufacturers had shirked their duty to alert FDA about it.
Attorney Jay Lefkowitz told the Court that if makers of generic drugs complied with strict state consumer laws by labeling their products different from the way innovator companies do, they would be violating federal law. Unmoved by this argument, Justice Ruth Bader Ginsburg observed that state laws are not at odds with federal law, they complement it.
Justice Samuel Alito wondered about the financial consequences of requiring generic-drug manufacturers to monitor for adverse events and inform FDA of them. “I don’t know whether this is a good idea or not, but it does seem to me that it may significantly increase the costs for generic drug manufacturers, and therefore counteract one of the objectives of the statute, which was to provide generic drugs at a low cost,” he said during arguments.
Justice Alito may have a point, but surely we should not overlook another objective of the law, which is to ensure that drugs are safe. The idea that the manufacturer of a generic drug can create and distribute a product without any responsibility for understanding it or ensuring that it does not harm its users is quite hard to swallow, in my opinion.
More than 70% of prescriptions filled in the US are generic drugs. The Court’s decision is expected in June, and it will surely affect a large section of the industry, one way or the other.