Stop STALLING Act Gives FTC Power to Fine Drug Companies $50K Daily for Baseless Delay Tactics

The newly proposed Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act—mercifully nicknamed the Stop STALLING Act—is designed to turbocharge the entry of generic drugs into the market. This bill gives the Federal Trade Commission (FTC) sharp new teeth to go after brand-name drug companies that file baseless administrative petitions with the FDA, not because they have a real legal argument, but just to slow down a competitor’s drug approval. Specifically, it targets “sham” petitions filed under Section 505(q) of the Food, Drug, and Cosmetic Act, defining them as applications that are completely without merit and solely intended to interfere with a rival’s business.

The Cost of Playing Dirty: New Penalties

If a company is caught submitting one of these sham petitions, they are automatically deemed to be engaging in an unfair method of competition, making the FTC’s job easier. The consequences are severe. If the FTC successfully sues a company in federal court, the civil penalty will be the greater of two amounts: either all the money the company made selling the drug product during the delay period, or a flat $50,000 for every single calendar day that the sham petition was under review by the Department of Health and Human Services (HHS). For regular folks, this is the key provision: if a drug company is delaying a cheaper generic version of a necessary medication, they could be facing millions in fines, which should make them think twice before filing a frivolous challenge.

HHS Flags and the Legal Presumption

Here’s where the bill gets really interesting from a legal standpoint. If the Secretary of HHS formally tells the FTC in writing that they believe a petition was filed mainly to delay an application and that it was part of a series of petitions, the court will presume the entire series is a sham. This presumption shifts the burden onto the accused company to prove—by a “preponderance of the evidence”—that their filings were legitimate. While the company can fight this presumption, the fact that the government’s referral automatically puts the burden of proof on them is a significant legal hurdle. This system is designed to cut through the bureaucratic fog and speed up enforcement, but it also grants significant power to the HHS referral process.

What This Means for the Real World

For consumers and generic manufacturers, this bill is a potential win. When a brand-name drug company uses these delay tactics, it can keep a generic drug—which often costs 80% less—off the market for months or even years. If the Stop STALLING Act works, it could mean faster access to cheaper medications for conditions ranging from high cholesterol to chronic pain. Think about the person paying $400 a month for a brand-name drug; getting a generic version six months earlier is a massive financial relief. However, for brand-name companies, the stakes are now much higher. The bill applies only to petitions filed after it becomes law, meaning the clock starts ticking immediately for any future filings. Companies that genuinely believe they have a legal challenge must now be extremely careful, as the penalties for getting it wrong—or being perceived as acting in bad faith—are astronomical, potentially leading to costly legal battles just to defend their intent.