Cracking down on pharma delay tactics to speed generic drugs
S. 1095 — Stop STALLING Act · Filed by Amy Klobuchar (D-MN) · 6 cosponsors · Introduced Mar 24, 2025 · Reported out
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What it does
This bill empowers the Federal Trade Commission to sue companies that file repetitive, baseless petitions to delay generic drug approvals. It defines a 'sham' petition as one that is objectively groundless and designed to obstruct a competitor's business rather than raise legitimate regulatory concerns. The FTC can impose civil penalties up to the greater of a company's drug sales revenue during the delay period or $50,000 per day per petition.
Why we flagged it
The bill's operative mechanism is to penalize frivolous petitions that delay generic drug approvals, thereby accelerating market entry of lower-cost alternatives and protecting consumer access to affordable medications.
What the text implies
- The bill creates a presumption that a series of petitions is a 'sham' if HHS determines the primary purpose was delay and refers it to the FTC, shifting burden to defendants to prove otherwise — a significant procedural advantage to the government and generic manufacturers.
- The $50,000-per-day penalty structure could impose massive liability on brand-name manufacturers (potentially millions of dollars for multi-year petition series), creating strong deterrent effect but also potential chilling of legitimate regulatory participation if the 'sham' definition is applied broadly.
The full analysis lists 4 implications of this text.
Who stands to gain
generic pharmaceutical manufacturers; pharmacy benefit managers; health insurers