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The Protecting Consumer Access to Generic Drugs Act of 2026 targets a practice known as 'pay-for-delay,' where brand-name drug manufacturers compensate generic or biosimilar drug manufacturers to postpone entering the market. This bill makes such agreements illegal if they involve payments or anything of value in exchange for delaying research, development, manufacturing, marketing, or sales of generic or biosimilar drugs. Exceptions are allowed if the compensation is clearly for other goods or services, or if the agreement involves legitimate rights to market the drug before patent expiration or reasonable litigation expense payments capped at $7.5 million.

The Federal Trade Commission (FTC) is empowered to enforce these rules, treating violations as unfair or deceptive acts. The FTC can impose penalties up to three times the value involved in the violation and seek injunctions or other relief. The bill also requires transparency by mandating that companies notify and certify agreements related to patent disputes involving generic or biosimilar drugs. Additionally, it modifies existing laws to ensure that companies engaging in illegal pay-for-delay agreements can lose certain exclusivity periods that delay generic competition.

This legislation is important because pay-for-delay agreements can keep drug prices high by blocking cheaper generic or biosimilar drugs from entering the market. By prohibiting these deals, the bill aims to increase competition, lower drug costs, and improve consumer access to affordable medications. However, it also includes safeguards to allow legitimate settlements and protects companies' rights under antitrust laws. The practical effect would likely be faster availability of lower-cost generic and biosimilar drugs, benefiting consumers and healthcare systems, while increasing regulatory oversight of patent settlement agreements in the pharmaceutical industry.