Faster Approval of New Over-The-Counter Drugs for Consumer Choice.
This bill aims to streamline the FDA approval process for new non-prescription (OTC) drugs by requiring the agency to use the "least burdensome appropriate means" when evaluating their safety and effectiveness. This change is intended to speed up the availability of innovative self-care options, offering consumers greater choice and potentially reducing healthcare costs. It mandates that the FDA collaborate with drug sponsors to define necessary evidence efficiently.
Key points
Speeds up the market entry of new non-prescription (OTC) drugs by simplifying FDA review procedures.
Requires the FDA to use the "least burdensome" methods for assessing drug safety and effectiveness, lowering hurdles for manufacturers.
Mandates FDA meetings with applicants to efficiently determine the necessary scope of studies, increasing process transparency.
Introduced
Citizen Poll