WASHINGTON -- Makers of generic drugs cannot be sued under state law for side effects of their products, the Supreme Court ruled Monday, angering patients' rights advocates.
In a 5-4 decision, the justices overturned a multimillion dollar award to a woman who suffered damages from a generic medication, noting that federal law prohibits drugmakers from making changes in their warning labels without the approval of the FDA.
The case, Mutual Pharmaceutical v. Bartlett, involves a woman who, in 2004, was prescribed Clinoril, the brand name for the nonsteroidal anti-inflammatory drug sulindac. The pharmacist dispensed the generic version manufactured by Mutual. The woman developed an acute case of epidermal necrolysis and sued Mutual seeking damages for the severe disfigurement she developed. A jury awarded her $21 million, an award that was later upheld by a circuit court.
But the Supreme Court said the federal Food, Drug, and Cosmetic Act allows only the FDA to make labeling changes and supersedes state law -- including the one in New Hampshire where this case originated -- that tries to force drugmakers to make labeling or design changes when safety issues arise.
"Here, it is impossible for Mutual to comply with both its federal-law duty not to alter sulindac's label or composition and its state-law duty to either strengthen the warnings on sulindac's label or change sulindac's design," Justice Samuel Alito wrote for the majority.
The High Court said Monday the First Circuit Court of Appeals' ruling was flawed. The lower court said Mutual could have stopped selling sulindac if the drugmaker knew it was unsafe.
It was not until 2005 that the FDA ordered new labeling on all NSAIDs to include a warning for the condition.
The Generic Pharmaceutical Association, the Washington-based trade group of the generic-drug industry, hailed the decision, saying it reaffirms the FDA's authority to oversee the safety of drugs.
"When it comes to decisions on safety and approval of prescription medicine, the FDA is best equipped to make judgments that affect patients," Chief Executive Ralph Neas said in a statement. "The experts at FDA alone have the scientific knowledge, regulatory experience, and complete data to make these decisions."
Monday's decision frequently cited the 2011 case Pliva v. Mensing, which found that generic drugmakers were preempted in state failure-to-warn cases challenging the generics' safety because federal law prohibited changes to generic drug labels without changes to the branded drug's labeling.
"Generic-drug manufacturers' inability under current regulations to update the labeling of their products poses a threat to the safety of prescription drugs, creating unnecessary risks to patients," Michael Carome, MD, director of Public Citizen's Health Research Group, said in a statement.
The consumer advocacy group Public Citizen released a report Monday noting that many safety issues aren't recognized drugs until years after a drug receives FDA approval and are available in a generic form. According to the report, at least 53 drugs approved by the FDA more than 10 years ago have required new black box warnings in the past 5 years.
Public Citizen called on lawmakers and regulators to update post-marketing regulations to bring generics more in line with the safety requirements of their branded counterparts.
David Pittman
David Pittman is MedPage Today’s Washington Correspondent, following the intersection of policy and healthcare. He covers Congress, FDA, and other health agencies in Washington, as well as major healthcare events. David holds bachelors’ degrees in journalism and chemistry from the University of Georgia and previously worked at the Amarillo Globe-News in Texas, Chemical & Engineering News and most recently FDAnews.
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