Allows the Federal Trade Commission to sue companies that file sham citizen petitions to delay approval of a competing generic drug or biosimilar, with civil penalties of up to the greater of the drug's revenue or $50,000 per day under review.

• Defines a sham petition as one that is objectively baseless and uses the government process to interfere with a competitor's business rather than to win the outcome.
• Lets the Federal Trade Commission bring a civil action against anyone who submits a sham petition or series of petitions, treating it as an unfair method of competition.
• Presumes a petition is part of a sham series when the Secretary of Health and Human Services refers it in writing, with a reasoned basis, as filed primarily to delay approval, unless the defendant shows otherwise by a preponderance of the evidence.
• Applies to covered petitions submitted on or after the date of enactment.

• Judiciary Committee (Senate)

Health