The "Stop STALLING Act" empowers the FTC to penalize companies that file objectively baseless petitions to unfairly delay the approval of competing drugs.
Amy Klobuchar
Senator
MN
The Stop STALLING Act aims to prevent pharmaceutical companies from filing frivolous petitions with the intent of delaying the approval of generic drugs and hindering competition. It empowers the Federal Trade Commission (FTC) to take civil action against those who submit "sham" petitions, defined as objectively baseless petitions intended to interfere with a competitor's business. Penalties for submitting sham petitions include substantial fines, potentially based on the revenue earned due to the delayed drug approval. The Act clarifies that it does not alter existing antitrust laws and applies to petitions submitted after the Act's enactment.
Stop STALLING Act Gives FTC Power to Penalize Pharma Companies for Bogus Petitions Delaying Generic Drugs
Ever wonder why that cheaper generic version of a pricey medication takes so long to hit the shelves? Sometimes, it's because companies file petitions that are less about safety and more about slowing down the competition. The Stop STALLING Act aims to put a stop to that by giving the Federal Trade Commission (FTC) new tools to go after these tactics.
What's a 'Sham' Petition Anyway?
The core idea here is tackling what the bill calls "sham" petitions. Under the Federal Food, Drug, and Cosmetic Act (specifically section 505(q)), anyone can petition the FDA regarding a pending drug application, often raising safety or efficacy concerns. That's generally a good thing for public health. However, this bill targets petitions deemed "objectively baseless" and filed mainly to interfere with a competitor's drug application – essentially, using the system to stall generic or biosimilar drug approvals.
The FTC Steps In: New Rules of the Game
This Act labels filing a "sham" petition (or a series of them) an "unfair method of competition." This gives the FTC, the nation's consumer protection watchdog, the green light to sue companies pulling these moves. Here’s how it works:
- Presumption of Sham: If the Secretary of Health and Human Services (HHS) flags a petition to the FTC, stating it was likely filed just for delay, it's presumed to be a sham. This is especially true if it's part of a pattern.
- Burden of Proof Shifts: The company accused then has to prove their petition wasn't a sham – that it had a legitimate basis beyond just messing with a competitor.
- The Penalty Box: If a company is found liable, the penalties are steep. They could face a civil penalty equal to either the total revenue they earned from the brand-name drug during the delay period or $50,000 per day the sham petition was under review – whichever amount is greater. This isn't just a slap on the wrist; it's designed to make stalling tactics financially painful.
Real-World Impact: Faster Access vs. Potential Chilling Effect?
The goal is clear: get lower-cost generic drugs to market faster by discouraging companies from gaming the petition system. If successful, this could mean noticeable savings on prescription costs down the line for everyday people needing medications.
However, the definition of "sham" – "objectively baseless" and intended to interfere – will be critical. While the bill provides a definition, there's always a gray area. The concern is whether the hefty penalties might unintentionally discourage companies from filing legitimate petitions that raise valid safety or scientific concerns, fearing they could be misconstrued as shams. The bill clarifies this doesn't override existing antitrust laws, but focuses specifically on this petition process.
This applies to petitions filed from the date the Act is enacted onwards. It's an attempt to level the playing field in the drug approval process, aiming to cut down on delays that ultimately cost consumers money.