The FDA, like most federal agencies, has immunity for most liability. You cannot sue them for approving a drug that kills someone, you cannot sue them for failing to approve a necessary drug. You cannot sue them for misrepresentation or incompetence, regardless of harm.
Federal prosecutors may be able to charge individuals at the FDA with fraud or crimes, if egregious enough. But I don’t know of it ever happening, and it would not happen without pretty significant evidence of malice rather than just incompetence or misaligned incentives.
The FDA, like most federal agencies, has immunity for most liability. You cannot sue them for approving a drug that kills someone, you cannot sue them for failing to approve a necessary drug. You cannot sue them for misrepresentation or incompetence, regardless of harm.
Federal prosecutors may be able to charge individuals at the FDA with fraud or crimes, if egregious enough. But I don’t know of it ever happening, and it would not happen without pretty significant evidence of malice rather than just incompetence or misaligned incentives.
Random search turned up https://www.nytimes.com/1989/04/28/business/fda-official-faces-us-charges.html so it does happen. It does seem rare.