Why PDUFA Reauthorization Matters for Georgia’s Patients and Economy

For Georgians living with serious and rare diseases, how quickly and predictably a new treatment moves through U.S. Food and Drug Administration (FDA) review can make a real difference. That predictability also matters to the researchers and businesses that make up Georgia's growing life sciences sector. Both depend in large part on the Prescription Drug User Fee Act (PDUFA), a longstanding bipartisan program that Congress needs to reauthorize by 2027.

How PDUFA Works

Since 1992, PDUFA has allowed the FDA to collect user fees from biopharmaceutical companies to supplement the agency's resources for reviewing new medicines. In exchange, the FDA commits to clear, predictable review timelines. The agency's standards for safety and efficacy remain unchanged. By providing additional resources and establishing clear performance goals, PDUFA helps ensure patients can access new treatments in a more timely and predictable manner.

The result of PDUFA have been significant. Before PDUFA, FDA reviews often took more than two years. Today, the median review time is 10 months for standard applications and 8 months for priority applications. In 2025, nearly 70% of new medicines were approved in the U.S. before any other country.

What's at Stake in 2027

Congress reauthorizes PDUFA every five years. The current agreement, PDUFA VII, expires September 30, 2027. Timely reauthorization is critical to maintaining the FDA's review capacity, preserving regulatory predictability, and ensuring patients continue to benefit from medical innovation.

Georgia stakeholders recently came together to talk through what that means here at home. On October 28, Georgia Life Sciences, the MTS Sickle Cell Foundation, and Georgia First hosted "PDUFA: How Medicines Reach People," a lunch-and-learn at Brookhaven City Centre. Patient advocates, congressional staff, and business and academic leaders heard from Nick Magallanes of Todd Strategy Group, Natalie Crawford of Georgia First, Maria Thacker-Goethe of Georgia Life Sciences, and Mapillar Dahn of the MTS Sickle Cell Foundation.

What We Heard

At the event, speakers came at PDUFA from different angles, but the common thread was how the program affects Georgians.

Mapillar Dahn of the MTS Sickle Cell Foundation stressed that patients need to remain at the center of conversations.

As a mother of three daughters with Sickle Cell Disease, Mapillar stressed that she wants the FDA to have what it needs to carry out a thorough review without unnecessary delays. The confidence families place in a treatment depends in part on confidence in that process.

Natalie Crawford with Georgia First and Mended Hearts spoke about the need for a fully resourced FDA so that Georgia patients have access to innovative treatments and also for a healthy Georgia economy.

Additionally, Maria Thacker-Goethe spoke to what PDUFA reauthorization means for Georgia's booming life sciences sector. She warned that without PDUFA reauthorization, research across the board will be stifled - ranging from devastating impacts to small startups to significant delays in investments and research.

Part of a National Conversation

As Congress prepares for the 2027 reauthorization, conversations like these help bring together patients, advocates, and community leaders to highlight the real-world importance of the program.

Decisions made in this reauthorization cycle will shape FDA resources and review timelines nationwide. By reauthorizing PDUFA on time, Congress can make sure the FDA can keep reviewing new medicines efficiently and patients in Georgia and across the country can get the treatments they need.



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