WASHINGTON — Supreme Court Justice Samuel Alito had a clear question at Tuesday’s arguments over the abortion pill mifepristone: If the doctors who brought that case can’t sue the FDA over a drug’s label, who can? And when?
“Is there anybody who can sue and get a judicial ruling on whether what FDA did was lawful? And maybe what they did was perfectly lawful, but shouldn’t somebody be able to challenge that in court?” Alito asked the government’s lawyer.
While it’s not impossible to sue the FDA to restrict a drug’s label, or its prescribing rules, the circumstances are slim, experts told STAT Wednesday. To establish standing to challenge the FDA, plaintiffs would have to show not only that the agency’s drug approval directly harmed them, but that the harm would be addressed with its withdrawal or an updated label. For someone already injured by the product, an FDA change would not address those issues — which is why, when patients are looking for compensation for injury, they often sue the drugmaker or provider instead.
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