Gov. Kemp: Medical Device Manufacturer Gerresheimer Expands in Peachtree City

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. 

New Hypepotamus feature explores Georgia’s growing MedTech sector and opportunities to strengthen startup development, commercialization, and long-term industry growth Georgia’s life sciences industry is experiencing significant growth, fueled by major investments, expanding research capabilities, and an increasingly connected innovation ecosystem. From biotechnology and medical devices to diagnostics and digital health, the state continues to demonstrate its potential as a destination for life sciences innovation. As Georgia builds on that momentum, an important opportunity is emerging: ensuring that the startups and technologies developed here have the resources and support to grow, scale, and remain in the state. A new Hypepotamus feature, “Atlanta’s MedTech Momentum Faces a Test: Can Startups Stay and Scale?” , by Maija Ehlinger, explores this next phase of ecosystem development. Featuring perspectives from entrepreneurs, investors, and industry leaders, including Georgia Life Sciences President & CEO Maria Thacker Goethe, the article examines how Georgia can build on its existing strengths while addressing challenges facing emerging companies. A Strong Foundation for Continued Growth Georgia has made substantial progress in establishing itself as a competitive life sciences hub. Recent major investment announcements, including UCB’s planned $2 billion biologics manufacturing facility in Gwinnett County and Shriners Children’s planned investment of more than $153 million in a research institute at Science Square, reflect continued confidence in the state's capabilities and potential. The state also benefits from a strong network of research universities, healthcare systems, entrepreneurial support organizations, and innovative companies developing technologies that have the potential to improve patient care and advance medical discovery. Programs and facilities such as Georgia Tech's ATDC, BioSpark Labs, and other regional innovation resources provide important support for emerging companies, helping entrepreneurs move promising ideas toward commercial application. These assets represent a strong foundation for future growth. Addressing the Needs of a Maturing Ecosystem While Georgia's industry continues to advance, emerging MedTech and biotechnology companies face challenges that extend well beyond the state. A changing investment environment, increasingly complex commercialization pathways, and demand for specialized infrastructure are reshaping how early-stage companies develop and grow. The Hypepotamus article highlights some of these pressures, including the recent closure of Portal Innovations' Atlanta location and the challenges startups encounter in securing affordable laboratory space, early-stage capital, and industry connections. These developments underscore the importance of strengthening the support systems that enable innovation. They also reflect a broader opportunity for Georgia to build on its progress and ensure that companies at every stage of development can access the resources they need. “Our biggest opportunity is to become as good at growing and retaining life sciences companies as we are at attracting major investments,” said Thacker Goethe in the article. A Roadmap for Georgia’s Next Chapter This focus on growing and retaining innovative companies is central to Georgia Life Sciences' 10-year strategic roadmap , which outlines priorities to strengthen the state's life sciences ecosystem and long-term competitiveness. The roadmap recognizes that continued industry growth requires a coordinated approach to commercialization, access to capital, specialized infrastructure, workforce development, and partnerships across academia, industry, healthcare, and government. For early-stage companies, those connections are especially important. Access to research facilities, clinical partners, experienced mentors, investors, and manufacturing resources can make the difference between a promising discovery and a successful commercial enterprise. Through its industry councils, strategic partnerships, and ecosystem initiatives, Georgia Life Sciences is working to help strengthen these connections and support the development of an environment where companies can succeed at every stage of growth. Turning Momentum into Long-Term Opportunity Georgia's life sciences story is one of substantial progress and considerable opportunity. The next chapter will require building on that success with the same intentionality that has helped attract major industry investments and expand the state's research and innovation capabilities. That means continuing to support companies choosing Georgia for major investments while also strengthening the pathways that allow homegrown businesses to develop, commercialize, and scale here. The goal is not simply to attract life sciences innovation to Georgia, but to ensure Georgia is a place where innovation can take root, grow, and thrive. The Hypepotamus feature offers a timely perspective on the opportunities ahead and the importance of continued collaboration across Georgia's life sciences community.  Read the Full Hypepotamus Article