Ensuring Timely Access to Generics Act of 2023

Ensuring Timely Access to Generics Act of 2023

This bill establishes additional requirements related to citizen petitions concerning applications for generic drug or biosimilar market approval. (Citizen petitions are petitions submitted by third parties requesting that the Food and Drug Administration (FDA) take certain actions, such as requiring additional warnings on a drug.)

Under the bill, the FDA may deny a citizen petition that (1) was submitted primarily to delay the approval of the relevant application, or (2) does not on its face raise valid scientific or regulatory issues. Currently, the FDA may deny a petition as an attempt at delay only if the petition meets both of these requirements.

The bill also expressly requires a third party, before filing a lawsuit to force the FDA to set aside or prevent market approval of a generic drug or biosimilar, to first file a citizen petition with the information and arguments that form the basis of the lawsuit. A citizen petition must be filed within 60 days of when the filer knew or reasonably should have known the information that forms the basis of the petition.

Bill 118 s 1067, also known as the Ensuring Timely Access to Generics Act of 2023, aims to increase competition in the pharmaceutical industry by making it easier for generic drugs to come to market. The bill specifically targets the practice of "pay-for-delay," where brand-name drug manufacturers pay generic drug companies to delay the release of their cheaper alternatives.

The bill prohibits these pay-for-delay agreements, which have been criticized for keeping drug prices high and limiting consumer choice. By preventing these agreements, the bill seeks to encourage the timely entry of generic drugs into the market, ultimately leading to lower prices for consumers.

Additionally, the bill includes provisions to streamline the generic drug approval process, making it faster and more efficient for generic drugs to receive FDA approval. This will further incentivize generic drug manufacturers to bring their products to market, increasing competition and driving down prices. Overall, the Ensuring Timely Access to Generics Act of 2023 is aimed at promoting competition in the pharmaceutical industry and ensuring that consumers have timely access to affordable generic drugs.