A bill to increase the clarity and predictability of the process for developing applications for Rx-to-nonprescription switches.
See how your representatives voted on this bill.
DeepSyte matches this bill to the issues you care about and shows whether your reps' votes line up — not party, not press releases. Take the 2-minute values quiz to see your alignment.
Alignment with your views
Sign in and take the values quiz to see how this bill lines up with what you've said.
Summary
This bill amends the Federal Food, Drug, and Cosmetic Act to establish clearer procedures and guidance for pharmaceutical companies seeking to convert prescription drugs to over-the-counter (nonprescription) status. The bill requires the FDA to issue guidance within 18 months on the approval process for such switches, including evidentiary standards and how companies can demonstrate consumer safety and appropriate self-selection. It also requires the FDA to develop a stakeholder engagement plan and authorizes pre-submission meetings to help applicants develop their applications. Additionally, the bill directs the Government Accountability Office to report on the number and timeline of approved switches and any barriers to the review process.
Values analysis
Sign in and take the values quiz to get a personalized read on how this bill lines up with your positions.
How your representatives voted
Sign in to see how your representatives voted on this bill.