To amend the Federal Food, Drug, and Cosmetic Act to provide for expedited approval of priority nonprescription drugs, and for other purposes.

Key Points

• The bill creates a new FDA designation called a priority nonprescription drug, letting drug makers request faster review for certain new over-the-counter medicines.
• To qualify, a drug must be genuinely new, treat a condition in a way that offers a major public health benefit, or contain an ingredient never sold over-the-counter before. Addictive drugs and those needing special safety monitoring programs are excluded.
• The FDA must decide on designation requests within 60 days and then work more closely with the drug company, including extra meetings and a dedicated review team liaison, to speed up the approval process.
• Within 18 months of becoming law, the FDA must publish a public list of health conditions where a new over-the-counter drug could provide major benefits, giving companies a roadmap for where to focus development.
• The bill specifies that this faster process does not lower the scientific evidence needed to approve a drug, and the whole program automatically ends in 2032 unless Congress acts to extend it.