Preserve Access to Affordable Generics and Biosimilars Act
Preserve Access to Affordable Generics and Biosimilars Act
Plain Language Summary
# Summary of S 1096: Preserve Access to Affordable Generics and Biosimilars Act **What the Bill Does** This bill aims to prevent pharmaceutical companies from making secret deals that delay cheaper generic and biosimilar drugs (lower-cost copies of brand-name drugs) from reaching the market. Currently, when a generic drug maker challenges a brand-name drug's patent, the two companies can settle and agree to keep the generic version off shelves in exchange for payment or other benefits. This bill would prohibit such anticompetitive settlements, making it illegal for brand-name drug makers to pay generic competitors to stay out of the market. **Who It Affects and Key Provisions** The bill primarily affects pharmaceutical companies, generic drug manufacturers, and ultimately consumers who pay for medications.
It allows some legitimate settlements—such as paying for court costs or allowing a generic to launch before a patent expires—but blocks deals designed purely to protect profits by preventing cheaper alternatives. The bill presumes any settlement where a generic maker receives payment in exchange for limiting drug development has unfair anticompetitive effects, unless the companies can prove otherwise. The Federal Trade Commission would enforce these rules. **Current Status** The bill was introduced in the 119th Congress by Senator Amy Klobuchar (D-MN) and is currently in committee, meaning it has not yet been voted on by the full Senate.
CRS Official Summary
Preserve Access to Affordable Generics and Biosimilars ActThis bill prohibits parties from entering into any agreement that resolves or settles a patent claim related to the sale of a drug or biological product and that has anticompetitive effects. Such an agreement is presumed to have anticompetitive effects if the filer of a 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 exempt 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 U.S. patent. An agreement is also exempt if the agreement's pro-competitive benefits outweigh the anticompetitive effects.The bill provides for enforcement by the Federal Trade Commission (FTC). Violators are subject to penalties including the forfeiture of the 180-day marketing exclusivity period for a generic drug.Additionally, 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 and the Department of Justice concerning the agreement contains the complete agreement and any related agreements, including descriptions of any oral agreements or representations.
Latest Action
Placed on Senate Legislative Calendar under General Orders. Calendar No. 46.