21 U.S.C. § 335b — Civil penalties

(a) In general. The Secretary can fine anyone found to have done any of these things regarding an abbreviated (generic) drug application: (1) knowingly made a false statement or misrepresented an important fact to Health and Human Services staff; (2) bribed, tried to bribe, or paid an illegal gratuity to HHS staff; (3) destroyed, altered, removed, or hid — or had someone else destroy, alter, remove, or hide — an important HHS document or piece of evidence, to interfere with HHS's work; (4) knowingly failed to disclose an important fact about a drug that they had an obligation to disclose; (5) knowingly obstructed an HHS investigation into a drug; (6) is a drug applicant who knowingly hired, retained, or otherwise used the services of someone who is debarred under section 335a; or (7) is a debarred individual who provided services, during their debarment, to someone with a drug application. The penalty is up to $250,000 per violation for an individual and up to $1,000,000 per violation for anyone else. (b) Procedure. (1) The Secretary can assess this penalty through a formal order, after an on-the-record hearing on disputed facts and on the penalty amount; the Secretary can put witnesses under oath, gather evidence, and subpoena witnesses or records. Instead of that, the Attorney General — at the Secretary's request — can sue in court to collect the penalty, either alone or alongside other civil or criminal claims. (2) In deciding the penalty amount, the Secretary or the court must weigh the nature, circumstances, extent, and seriousness of the violation; the person's ability to pay; the effect on their ability to stay in business; any history of similar violations; and anything else justice calls for. (3) No case can be started over conduct that happened before May 13, 1992, or more than 6 years after the facts became known — or reasonably should have become known — to the Secretary, and never more than 10 years after the conduct itself happened. (c) Judicial review. Someone hit with an adverse penalty decision can ask the D.C. Circuit or the circuit where they live to review it, by filing within 60 days of being notified. (d) Recovery of penalties. The Attorney General can collect a final penalty — plus interest — by suing in the name of the United States, or by deducting it from money the government owes that person. Once collected this way, the penalty's validity, amount, and fairness can't be challenged again in court. (e) Informants. The Secretary can pay a reward to anyone (other than a federal employee or someone who took part in the wrongdoing) who provides information leading to a civil penalty under this section — up to $250,000, or half of the penalty actually collected, whichever is smaller. The Secretary's decision on this reward can't be appealed.