# What the Protecting Consumer Access to Generic Drugs Act Actually Does

This bill takes aim at a practice that's been quietly driving up drug prices: brand-name pharmaceutical companies paying generic drug makers to stay out of the market. Here's what's happening and why Congress wants to stop it.

When a brand-name drug's patent is about to expire, generic manufacturers can usually enter the market with cheaper versions. But sometimes, brand-name companies offer generic makers money or other valuable deals to delay launching their cheaper alternatives. This keeps prices high for patients who can't afford the brand-name drug. The bill makes these "pay-for-delay" deals illegal and gives the Federal Trade Commission (FTC) real power to punish companies that try them. If caught, companies could face penalties up to three times the value of whatever they paid to delay competition. The same rules apply to biological drugs (like insulin) and their cheaper biosimilar alternatives.

The bill also requires companies to report these agreements to the government and have executives certify they've disclosed everything—no hidden side deals. If a generic manufacturer violates the law by accepting a payoff to delay, they lose their special 180-day head start in selling their drug, which is a significant penalty. The FTC gets six years from when an agreement is filed to investigate and take action, giving them a reasonable window to catch violations.

Ultimately, this is about patients and consumers. When generic drugs can enter the market freely, prices drop dramatically—often by 80 to 90 percent. By blocking these anti-competitive deals, the bill aims to get cheaper medications to people faster and reduce what Americans pay for prescriptions.

Protecting Consumer Access to Generic Drugs Act of 2023

Perez, Marie Gluesenkamp

Protecting Consumer Access to Generic Drugs Act of 2023 This bill prohibits the manufacturer of a brand-name, generic, or biosimilar drug from entering into certain agreements to resolve or settle a patent infringement claim in connection with the sale of a drug or biological product. Specifically, such an agreement shall, with some exceptions, be a violation of the bill if the filer of a subsequent application to market a drug or biological product receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the subsequent drug or biological product. (Typically, a subsequent application seeks to market a generic or biosimilar version of a patented drug or biological product.) Penalties for violations of the bill include civil penalties and loss of the 180-day exclusivity period for a generic drug. The Federal Trade Commission (FTC) shall have exclusive authority to litigate to enforce the bill. When a generic or biosimilar drug manufacturer enters into an agreement with another drug manufacturer related to the manufacturing, marketing or sale of a drug, the manufacturers shall certify that the material they have given the FTC concerning the agreement contains (1) the complete agreement; and (2) any agreements related to the main agreement, including descriptions of any oral agreements or representations.