Bill > HR2455

This bill, the Ensuring Timely Access to Generics Act of 2019, amends the Federal Food, Drug, and Cosmetic Act to address issues with "citizen petitions" - petitions filed by individuals or organizations that can delay the approval of generic drug applications. The bill gives the FDA more guidance on how to determine if a citizen petition was filed primarily to delay approval, including factors like whether the petitioner took an unreasonable amount of time to file the petition, submitted multiple similar petitions, or filed close to a known approval date. The bill also allows the FDA to establish a timeline for filing petitions and summarily deny any filed after that timeline. Finally, it requires the FDA to publish a list of petitions deemed to be filed for the purpose of delay and to refer such petitions to the Federal Trade Commission.

Business and Industry, Health and Social Services

https://www.congress.gov/bill/116th-congress/house-bill/2455/all-info