Bill lets FTC sue drug makers over sham petitions delaying generics

What does this do?

The bill lets the FTC sue drug companies that file "sham" FDA citizen petitions not based on real safety concerns but meant to delay generic or biosimilar competitors. If HHS refers a petition to the FTC as mainly delay-motivated, it's presumed a sham, though companies can still defend themselves in court. Petitions filed in good faith over genuine safety issues are unaffected.

Who does it affect?

Pharmaceutical and biotech companies, especially brand-name drug makers, are directly affected; consumers may see indirect effects on generic drug availability.

Why does it matter?

Making sham petitions costlier and legally riskier could reduce a tactic used to delay generic competition, though the summary does not quantify broader market effects.

What does it cost, and who pays?

• Penalty based on profits from delay
• Or $50,000 per day, greater amount applies