FDA proposal to allow changed labels would end protection of Supreme Court rulings.
The Food and Drug Administration on Wednesday signaled its intention to permit the makers of generic drugs to change their safety labels, a move that could open the door to lawsuits against the companies for the first time since a Supreme Court decision barred such actions two years ago.
Consumer advocates applauded the development, calling it a necessary fix for a system they say is unfair to patients who take generic medicines.
“It’s common sense,” said Dr. Sidney M. Wolfe, a senior adviser to the Health Research Group at Public Citizen, which in 2011 petitioned the FDA to make just such a rule. “It will obviously end this situation where people are being harmed physically and yet, although they are harmed, they have no right to go into court and get redress for serious damages.”
Dozens of lawsuits against the makers of generic drugs have been dismissed since 2011, when the Supreme Court ruled that because the companies must, by law, use the same label warnings as the makers of brand-name drugs, they cannot be sued for failing to alert patients to the risks of taking their drugs.
Last month, the Supreme Court ruled — on similar grounds — that patients may not sue makers of generic drugs by claiming that such drugs were defectively designed.
The FDA’s intentions came in the form of a bureaucratic step in which the agency must notify the Office of Management and Budget of its plans to publish a proposed rule.
In a summary posted Wednesday on the budget office’s website, the FDA said the proposed rule would “create parity” between those who make generic and brand-name drugs with respect to how they update their labels — the lengthy list of a drug’s uses, dosages and risks.
Under the current system, makers of brand-name drugs can change a label if they receive important new information about their drug. If the FDA agrees that the label change is necessary, the makers of generic counterparts must also change their labels. The rule change could allow makers of generic drugs to change their labels if they became aware of safety concerns, which could make them liable if a court were to find they failed to warn patients about potential harms.
“It is a first step toward acknowledging that there is a problem with the current system,” said Michael Johnson, a lawyer who represented Gladys Mensing, one of the patients who sued generic drug companies in the 2011 Supreme Court case, Pliva vs. Mensing. “It doesn’t make sense to have one set of rules for the name brand and another set of rules for the generics.”
Sandy Walsh, an FDA spokeswoman, noted that the agency had said before that it was considering such a rule change.
“It is premature to cite what changes in the regulations might be,” she said in an e-mail. “Discussions are under way.”
The Generic Pharmaceutical Association, an industry group, declined to comment Wednesday.
In the past, the makers of generic drugs have argued against such a change, saying that it could create a chaotic situation in which several different labels existed for the same drug.
Jay Lefkowitz, the lawyer who represented the makers of generic drugs in both Supreme Court cases, said in an e-mail, “We will obviously look very carefully at whatever the FDA proposes, if in fact it ends up proposing any change at all.”
The notice posted Wednesday indicates the agency’s intent to publish a proposed rule by September, when the public would be asked to comment.