Senate bill extends FDA over-the-counter drug fee program to 2030

What does this do?

S 2292 renews a program requiring manufacturers of over-the-counter drugs to pay fees to the FDA through September 30, 2030. The bill sets specific fee amounts for fiscal years 2026 through 2030 and adjusts payment schedules and collection procedures. It also expands what qualifies as an OTC drug product update to include changes to testing procedures that meet recognized international quality standards.

Who does it affect?

Manufacturers and facilities that produce OTC drug products sold in the United States are directly required to pay the fees. Consumers who purchase non-prescription medicines at pharmacies and stores are indirectly affected because the fees fund FDA oversight of those products.

Why does it matter?

Without this bill, the fee program would expire and the FDA's funding for reviewing and updating OTC drug safety and quality rules would not be sustained. Fee levels can increase based on inflation or significant growth in the number of manufacturing facilities paying into the program.

What does it cost, and who pays?

• Fees set for FY 2026–2030
• Increases allowed for inflation
• More facilities can raise fee totals