Summary#
This bill lets the Federal Trade Commission (FTC act) treat certain citizen petitions about drug approvals as unfair competition when those petitions are used mainly to delay approval of competing generic drugs or biosimilars. The bill defines a "sham" petition as one that is objectively baseless or a series of petitions used to interfere with a competitor by using the government process rather than the outcome. If the Secretary of Health and Human Services (HHS) determines a petition was filed primarily to delay approval and refers that determination to the FTC with reasons, the petition is presumed part of a sham series unless the petitioner proves otherwise. The FTC may sue in federal court, seek civil penalties and other relief, and the bill makes clear it does not limit other antitrust or FTC authorities. The law applies to covered petitions filed on or after enactment and includes a severability clause.
What it means for you#
- If you submit a citizen petition that is found to be a sham, the FTC could bring a civil action against you for unfair competition.
- The HHS Secretary can refer petitions to the FTC with a reasoned finding that the petition was filed mainly to delay a covered drug approval; such referrals create a legal presumption in FTC cases.
- Companies that apply to approve generic drugs or biosimilars may face fewer delays from petitions that federal agencies treat as sham attempts to block competition.
- The bill applies only to petitions related to certain drug approval applications and to petitions filed on or after the law is enacted.
Expenses#
- The bill authorizes civil penalties for each violation. A person found liable may be fined up to the greater of:
- the revenue the person earned from sales of any drug referenced in the covered application during the period the petition(s) was under HHS review; or
- $50,000 for each calendar day each sham petition (or petition in a sham series) was under HHS review.
- The bill says these penalties are in addition to other federal remedies under antitrust law or the FTC Act.
- No publicly available information on broader budgetary or administrative costs to federal agencies is provided in the bill text.
Proponents' View#
The bill is described as enabling the FTC to deter filing of sham citizen petitions that are intended to interfere with approval of competing generic drugs or biosimilars. It aims to foster competition and help federal agencies review petitions filed in good faith that raise real public health concerns.
Opponents' View#
No publicly available information.