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Preserve Access to Affordable Generics and Biosimilars Act
3/13/2024, 3:50 PM
Summary of Bill S 142
The bill specifically targets practices such as pay-for-delay agreements, where brand-name drug companies pay generic manufacturers to delay the release of their cheaper alternatives. These agreements can significantly increase drug prices and limit consumer access to more affordable options.
Additionally, the bill seeks to address the issue of product hopping, where brand-name drug companies make minor changes to their products in order to extend their patent protections and prevent generic competition. This practice can also lead to higher drug prices and hinder access to more cost-effective alternatives. By prohibiting these anti-competitive practices, the Preserve Access to Affordable Generics and Biosimilars Act aims to lower drug costs for consumers, increase competition in the pharmaceutical industry, and improve access to affordable medications. This legislation is crucial in ensuring that patients have access to the medications they need at prices they can afford.
Congressional Summary of S 142
Preserve Access to Affordable Generics and Biosimilars Act
This bill authorizes the Federal Trade Commission (FTC) to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement is presumed to have anticompetitive effects and is a violation of this bill if the filer of the generic drug or biosimilar application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar.
An agreement is exempted if the only consideration granted to the generic manufacturer is (1) the right to market and secure final approval for its product prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on any claim that the generic drug or biosimilar infringes a patent. An agreement is also exempt if the agreement's pro-competitive benefits outweigh the anticompetitive effects.
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 must certify that the material they have given the FTC concerning the agreement contains the complete agreement and any agreements related to that main agreement, including descriptions of any oral agreements or representations.
The bill imposes penalties for violations of this bill, including the forfeiture of the 180-day marketing exclusivity period for a generic drug.
