One particular penalty that is an option is being disbarred from participating in Medicare/Medicaid. Depending on the disease the drug treats, that can be 50% of your market. And you're disbarred as an entity, not just the individual drug.

Interesting, when Pfizer was found to be promoting off-label use of their drug (another no-no), they were disbarred. Well... their Pharmacia-Upjohn subsidiary was disbarred. Luckily that entity doesn't actually have any sales.