Recently, there has been a lot of talk about proposed changes to federal laws that govern generic drug labeling. The Food and Drug Administration has proposed a law that would make generic manufacturers responsible for updating the warning labels on their products. This proposed law is a reaction to a recent Supreme Court case called PLIVA, Inc. v. Mensing. Understanding what happened, in this case, may help guide our understanding of the purpose of and need for the FDA’s proposed law.
The PLIVA, INC. v. Mensing Case
In Mensing, the plaintiffs were prescribed the brand-name drug Reglan to treat their digestive tract disorders in 2001 and 2002. Instead of the name-brand Reglan, these individuals received the generic form of Reglan – metoclopramide – which was manufactured by PLIVA, Inc. After years of taking metoclopramide, the plaintiffs developed tardive dyskinesia, a severe neurological disorder that causes involuntary repetitive movements. This condition often irreversible.
Brand Name Gets Black Box Warning
In 1985, the manufacturers of Reglan had put a warning on their product that cautioned that “‘tardive dyskinesia . . . may develop in patients treated with metoclopramide.” However, at that time, the package insert indicated that use for longer than 12 weeks had not been evaluated and could not be recommended. In 2009, the FDA ordered its strongest warning, the “black box warning,” on Reglan, stating that treatment with the drug can cause tardive dyskinesia and that “treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases.”
Generic Does Not
The plaintiffs who took the generic drug in 2001-2002 argued that there was sufficient evidence to change the label to a stronger warning. Although state law in the plaintiffs’ respective states required prescription drug manufacturers to adequately warn of their drugs’ dangers, federal law did not require a manufacturer of a generic prescription drug to upgrade the warnings.
Federal v. State Law: Who Gets the Final Say?
As explained in our previous blog, actions taken by generic drug manufacturers are limited by the current regulatory framework. Both generic-drug manufacturers and brand-name drug manufacturers must obtain FDA approval. However, a generic drug is required to maintain the same labeling as its corresponding brand-name drug (with some limited exceptions). The process through which labels are changed is via the Changes Being Effected (CBE) supplement process. Only brand-name manufacturers may use the CBE process. If the FDA approves a brand-name manufacturer’s label change, generic-drug manufacturers must make that same change to the corresponding generic drug’s label as soon as possible.
The Supreme Court Weighs In
The Supreme Court found because the FDA prohibits generic-drug manufacturers from independently altering their labels to reflect newly acquired information about the effects of their drug, they cannot be liable for failing to make such changes. The Court held that it was impossible for generic manufacturers of the drug in question to comply with both their state-law duty to change the drug’s label to a different, safer label that adequately warned of the injuries alleged, and their federal law duty to keep the label the same..
The Supreme Court also based the Mensing decision on its interpretation of the U.S. Constitution’s Supremacy Clause, which states that federal law is the “supreme Law of the Land” and trumps state and local laws if there is any conflict. “Reasoning that federal law is supreme over state law – even if the state law made the drug safer because of stricter warning label requirements – the Court found that federal statutory preemption of failure-to-adequately-warn claims involving a generic prescription drug was thus final.”
This ruling limited product liability plaintiffs’ remedies. The Mensing decision essentially held that certain failure to warn claims against generic drug manufacturers are preempted, while those same claims against brand-name drugs are not. Therefore, many who use generic brand drugs are unable to pursue their claims against the manufacturers and had little recourse.
The FDA Response
The FDA responded to this ruling by issuing a proposed rule that was open to public comment until April 27th. The new rule would:
- Permit generic-drug manufacturers to use the CBE process independent of brand-name manufacturers;
- Open a FDA website containing the proposed label changes and background information submitted by generic-drug manufacturers;
- Require the generic-drug manufacturers that submit CBE supplements to monitor the information posted on the website and notify the FDA if any of the information is incorrect; and
- Impose a 30 day deadline for generic-drug manufacturers to update their labels to match those of the brand-name equivalent.
Though the time for public comment has passed, A&G is keeping a close eye on any developments in this extremely important decision and will continue to update as news becomes available.