Technical corrections only. The two versions of the bill, S. 1095, are substantively identical. The only changes reflect an update in the legislative status, indicating that v2 (Reported in Senate) was reported by the Committee on the Judiciary without amendment after v1 (Introduced in Senate).
Stop STALLING Act
- Sponsor
- Sen. Klobuchar, Amy [D-MN]
- Committees
- Judiciary Committee (primary)
- Last action
- Apr 10, 2025
Bottom line
This bill aims to curb anti-competitive practices by pharmaceutical companies that use regulatory loopholes to delay generic drug entry, empowering the FTC to impose significant financial penalties.
What it actually does
The Stop STALLING Act empowers the Federal Trade Commission (FTC) to take enforcement action against pharmaceutical companies that file 'sham' citizen petitions with the Food and Drug Administration (FDA). These petitions, often filed under Section 505(q) of the Federal Food, Drug, and Cosmetic Act, can delay the approval of competing generic drugs or biosimilars. The bill defines what constitutes a 'sham' petition and establishes civil penalties for companies found to be engaging in such practices, aiming to foster competition and expedite the review of legitimate public health concerns.
Proponents argue
Proponents argue that the bill is crucial for lowering prescription drug costs by preventing brand-name drug manufacturers from abusing the citizen petition process to block or delay the market entry of cheaper generic and biosimilar alternatives. They contend that such delays cost consumers billions of dollars annually and stifle innovation, and that this bill provides a necessary enforcement tool to deter these anti-competitive tactics while preserving the ability to file legitimate petitions.
Opponents contend
Opponents, typically representing brand-name pharmaceutical companies, might argue that the existing citizen petition process is a vital mechanism for raising legitimate scientific and public health concerns about drug applications, and that this bill could chill the exercise of these rights. They may contend that the definition of 'sham' is overly broad or subjective, potentially leading to arbitrary enforcement and discouraging valid petitions, thereby compromising patient safety or the integrity of the drug approval process.
The bill is concise and relatively easy to read, allowing for a quick understanding of its core provisions within a typical legislative review timeframe.
Section 2(a)(6)
Definition of "Sham" Citizen Petition
This provision defines a "sham" petition as one that is "objectively baseless" and attempts to use the governmental process itself (as opposed to the outcome of that process) to interfere with a competitor's business. This definition also applies to a "series of covered petitions." This definition is critical as it sets the legal standard for what the FTC can prosecute, distinguishing between legitimate regulatory engagement and anti-competitive abuse.
Supporters argue
Supporters argue this definition is carefully crafted to target only abusive petitions, distinguishing them from legitimate concerns, thereby protecting public health while promoting competition.
Critics contend
Critics may argue the definition is vague or could be broadly interpreted, potentially chilling legitimate petitions and raising concerns about due process for companies trying to protect intellectual property or raise safety issues.
Tradeoffs
Balances the need to deter anti-competitive behavior with the right of stakeholders to petition the government with legitimate concerns regarding drug approvals.
Section 2(b) and 2(c)(1)
FTC Authority to Act Against Sham Petitions
This provision declares that submitting a sham petition constitutes an "unfair method of competition" under Section 5(a)(1) of the Federal Trade Commission Act. It explicitly grants the FTC the power to initiate civil actions in federal court to recover civil penalties and seek other appropriate relief against any person who submits or causes the submission of sham petitions. This establishes the legal basis for the FTC's enforcement role.
Section 2(c)(2) and 2(c)(3)
Presumption of Sham Petitions and Defendant's Rebuttal
This section establishes a legal presumption: if the Secretary of Health and Human Services (HHS) determines a petition was submitted primarily to delay approval and refers it to the FTC, and it's part of a series of petitions, it's presumed to be a sham. However, the defendant can rebut this presumption by proving, with a preponderance of the evidence, that the series of petitions is not a sham. This mechanism aims to streamline enforcement by leveraging FDA's expertise.
Section 2(c)(4)
Imposition of Civil Penalties
This provision sets the civil penalties for submitting a sham petition. A liable person will be fined the greater of (A) any revenue earned from the sale of the drug product referenced in the covered application during the period the sham petition was under FDA review, or (B) $50,000 for each calendar day the sham petition (or series of petitions) was under FDA review. These penalties are designed to be substantial financial deterrents.
This subsection specifies that the HHS Secretary's referral to the FTC (which triggers the presumption of a sham petition) is not directly subject to judicial review. Instead, it can only be challenged as a third-party claim asserted by the defendant against HHS within the FTC's civil action.
Section 2(c)(5)
Why it matters:This is standard legislative practice to define the scope and timing of judicial review for administrative actions, aiming to prevent pre-emptive lawsuits that could further delay enforcement. It consolidates legal challenges.
Case for: Supporters would argue this prevents dilatory tactics by defendants who might otherwise challenge the HHS referral in a separate lawsuit, further delaying the FTC's enforcement action. It ensures that all challenges are consolidated within the main FTC case.
Case against: Critics might argue that limiting direct judicial review of the HHS referral could make it harder for defendants to challenge potentially flawed or biased administrative determinations, thereby weakening due process.
Estimated impact: Streamlines the legal process for FTC enforcement actions, potentially reducing the overall time and cost of litigation.