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

This bill would let drug makers ask the federal health department to designate an over-the-counter (nonprescription) drug as a "priority nonprescription drug," with a decision due within 60 days. Drugs could qualify if they treat a new nonprescription use with a public health benefit, are a new molecular entity, or contain an ingredient never before sold without a prescription; controlled substances and drugs under special risk-management programs would be excluded. For designated drugs, the Food and Drug Administration would take steps to speed up development and review, such as more meetings and advice to the drug maker, while keeping the same approval standards. The department would publish a list of conditions where nonprescription drugs could help public health, report results to Congress within 4 years, and the program would end September 30, 2032.

Full text and official record on Congress.gov

Sponsors

• Robert E. Latta Republican sponsor
• 1 cosponsors