Inflation Reduction Act

In 2022, Congress passed and the President signed the Inflation Reduction Act (P.L. 117-169) known as the IRA. One of the health-related provisions included the ability for the Secretary to negotiate the prices for certain drugs within the Medicare program. The process of selecting certain drugs, announcing their negotiated prices, and then implementing those price controls across Medicare is ongoing.

While well-intended, AAM and the Biosimilars Council have consistently noted that the timelines outlined in the law do not provide sufficient opportunity for generic and biosimilars to enter the market before the price negotiations are in place. Because of this, the environment for healthy competition and a sustainable generic marketplace is negatively impacted. And patients lose out.