The Food and Drug Administration’s new ANDA Prioritization Pilot realigns regulatory incentives to reward onshore bioequivalence testing and U.S. manufacturing of finished dosage forms and active pharmaceutical ingredients (API), and it will strengthen supply‑chain resilience, lower inspection costs, and speed patient access to affordable generics. The policy leverages FDA review speed as a targeted market signal: companies that invest in U.S. testing and production can secure priority review for their abbreviated new drug applications (ANDAs), giving domestic manufacturers a predictable regulatory advantage.

Why this matters 

More than half of pharmaceuticals distributed in the U.S. rely on overseas manufacturing and testing, creating vulnerability to disruptions, slower inspections, and higher taxpayer inspection costs. By making priority review contingent on pivotal bioequivalence studies conducted in the U.S. and on domestic API and finished-dose manufacturing, the pilot creates a clear, enforceable pathway for reshoring high‑value activities and rebuilding onshore technical capacity.

Policy design strengths

• Rewards U.S. bioequivalence testing, U.S. finished‑dose manufacturing, and U.S. API supply with a valuable regulatory benefit – faster ANDA review.
• Low administrative burden for applicants – priority requests follow FDA’s existing MAPP 5240.3 procedures and require straightforward documentation of testing and manufacturing locations.
• Aligned with broader FDA initiatives such as PreCheck to accelerate establishment of priority manufacturing facilities in the U.S., creating complementary pathways for investment and facility readiness.

Risks and implementation challenges

• Supply‑chain economics may limit near‑term uptake. Building U.S. API capacity and testing infrastructure requires capital, skilled personnel, and multi‑year timelines. Firms may need additional incentives beyond review speed to onshore critical steps.
• Verification and inspection workload could shift rather than shrink. Increased domestic facilities mean more U.S. inspections and oversight resources will be required even as foreign inspection demands decline.
• Equity of priority selection. The FDA must maintain transparency in prioritization adjudication to avoid unintended market distortions or favoritism while preserving public‑health priorities.

Recommendations to maximize impact

1. Pair the ANDA Prioritization Pilot with targeted financial incentives such as tax credits, low‑interest loans, or matching grants for U.S. API and bioequivalence lab expansion to accelerate private investment.
2. Publish clear metrics and a timetable for measuring pilot outcomes. Number of ANDAs granted priority, shift in domestic API share, inspection workload changes, etc – to enable data‑driven adjustments.
3. Expand workforce development support for analytical, bioequivalence, and manufacturing technicians to ensure capacity growth is sustainable.
4. Coordinate with reimbursement and procurement levers (public purchasers, Medicaid formularies) to create demand signals for U.S‑made generics when clinically appropriate.

Reference

FDA — FDA Announces New ANDA Prioritization Pilot to Support U.S. Generic Drug Manufacturing and Testing