Bill > S1169

This bill amends the Federal Food, Drug, and Cosmetic Act to address citizen petitions. It provides factors the FDA must consider in determining whether a citizen petition was submitted primarily to delay the approval of a generic drug application, including whether the petitioner took an unreasonable time to submit the petition, submitted multiple similar petitions, or submitted the petition close to a known approval date. The bill also requires the FDA to publish a list of petitions determined to be submitted for the primary purpose of delay and establishes procedures for referring such petitions to the Federal Trade Commission. Additionally, the bill allows the FDA to establish a timeline for submitting petitions, after which late petitions can be summarily denied.

Health and Social Services

https://www.congress.gov/bill/116th-congress/senate-bill/1169/all-info