FDA Acts on Generic Drug Safety

Reading this article from The New York Times, it is encouraging to see that the FDA may make new rules requiring generic drug manufacturers to update drug labels with new safety information. What remains to be seen is whether the new rules will open the door that the Supreme Court says is closed to people seriously injured by generic drugs. Slack Davis Sanger will continue to monitor this issue. – SK

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F.D.A. Rule Could Open Generic Drug Makers to Suits
by Katie Thomas, The New York Times
July 3, 2013

The Food and Drug Administration on Wednesday signaled its intention to permit generic drug makers to make changes to their safety labels, a move that could open the door to lawsuits against generic drug companies for the first time since a Supreme Court decision barred such suits two years ago.

Consumer advocates applauded the development, calling it a necessary fix for a system that 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 F.D.A. to pass 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 generic drug manufacturers have been dismissed since 2011, when the Supreme Court ruled that because the generic companies must, by law, use the same label warnings as their brand name counterparts they cannot be sued for failing to alert patients about the risks of taking their drugs. Last month, the Supreme Court ruled — on similar grounds — that patients also may not sue generic drug makers by claiming that the drug was defectively designed.

The F.D.A.’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 new rule. In a summary posted Wednesday on the budget office’s Web site, the F.D.A. said the proposed rule would “create parity” between generic and brand-name drug makers with respect to how they update their labels — the lengthy list of a drug’s uses, dosages and risks.

Under the current system, brand-name manufacturers can change the label if they receive important new information about their drug. If the F.D.A. agrees that the label change is necessary, the generic manufacturers of the drug must also change their labels. The rule change could also allow generic manufacturers 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 v. 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 F.D.A. 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 on Wednesday. In the past, generic drug companies 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 generic drug makers in both Supreme Court cases, said in an e-mail, “We will obviously look very carefully at whatever the F.D.A. 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.