Hatch-Waxman Act: Celebrating 40 Years of a Balanced and Innovative Drug Ecosystem

In 1984, the Hatch-Waxman Act – formally known as the bipartisan Drug Price Competition and Patent Term Restoration Act – established a legal and regulatory framework that propelled the modern biopharmaceutical industry.

 

Forty years later, the U.S. biopharmaceutical industry thrives with a balance of innovation and affordability, thanks to the law that encourages companies to research and develop cutting-edge medicines while creating a process for lower-cost generics with the same clinical benefit to come to market.

 

As we approach this milestone anniversary, however, the system that has created so many breakthroughs faces a critical threat. Misguided attempts by policymakers to address drug costs by weakening intellectual property protections would upend the delicate balance that has enabled America’s life sciences industry to create life-saving cures. A proposal to invoke so-called march-in rights on patents for drugs that were supported in part by federal funding would jeopardize investments in groundbreaking research and undermine the incentives for the discovery of new treatments. This ultimately harms patients who depend on new therapies.

 

Affordable generics are born from the significant research and investment needed to produce branded drugs. Weakening crucial intellectual property protections will lead to neither being developed.

 

As we reflect on the 40 years of progress enabled by the Hatch-Waxman Act, patients are counting on policymakers to preserve the delicate balance between innovation and affordability that has made the United States a global leader in developing new medicines.

 

Learn more about the Hatch-Waxman Act here, and learn more about America’s leadership in the life sciences at www.weworkforhealth.org/ip.

Investing in America’s Biopharmaceutical Infrastructure Strengthens the Economy and Supports Union Workers

By Maria Thacker Goethe • December 20, 2025
The biopharmaceutical industry is growing America’s manufacturing and R&D capabilities to develop the next generation of treatments. A recent study from PILMA quantified the impact of the industry’s investment in American infrastructure on the economy and union workforce across 18 states from 2019-2024. The study found that across the 18 states included, the biopharmaceutical industry: Supported the American economy by investing $86.5B in R&D and manufacturing infrastructure and developing 1000+ construction projects at over 700 distinct facilities. Strengthened the American workforce by generating $2.6B in skilled union wages and providing $19M in support for union apprenticeships. The impact of the biopharmaceutical industry’s investment in American manufacturing and union jobs extends beyond direct benefits, spurring additional economic activity in the communities where workers live. This is known as the multiplier effect . On average, every $1 of new investment in a U.S. biopharmaceutical manufacturing facilities generates an additional $1.59 in further economic activity (2.59x times the initial investment value). The industry’s $86.5B investment in R&D and manufacturing infrastructure has a total economic impact of $224B. Check out this resource to learn more about how biopharmaceutical investment in American infrastructure supports America’s workers and communities. For more on how biopharmaceutical companies are investing in America’s future, visit innovation.org/america-investment .

Georgia Life Sciences Joins National Coalition Urging Congressional Action on Key Innovation Policies

December 10, 2025
Georgia Life Sciences has joined 43 state and regional life sciences organizations in signing a national Council of State Bioscience Associations (CSBA) letter calling on Congress to take immediate action on three bipartisan policy priorities that are essential to sustaining U.S. leadership in biomedical innovation and supporting patients nationwide. With Congress back in session and several critical programs at risk of expiring, the letter urges congressional leaders to advance the following provisions without delay: 1. Reauthorize the Rare Pediatric Disease Priority Review Voucher (PPRV) Program The PPRV program has been instrumental in incentivizing the development of therapies for children with rare and life-threatening conditions. Its lapse threatens to slow or halt research that families across the country are counting on. 2. Extend the SBIR/STTR Programs The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs provide crucial early-stage capital for emerging biotech and medtech companies—many of them in Georgia. Without reauthorization, hundreds of innovative small businesses face uncertainty, jeopardizing new therapies, diagnostics, and technologies in the pipeline, 3. Advance PBM Transparency Reforms Greater transparency and accountability within pharmacy benefit manager (PBM) practices are needed to ensure that savings reach patients and employers. Reforming PBM operations is essential to strengthening access and affordability across the healthcare system. A Unified Message from the Life Sciences Community The sign-on letter reflects broad, bipartisan alignment across the national life sciences ecosystem: researchers, entrepreneurs, investors, patient advocates, and state associations all share a common message— these programs underpin America’s global competitiveness and are vital to patients who rely on continued scientific progress. Georgia Life Sciences has shared the letter with members of Georgia’s congressional delegation and will continue engaging with policymakers to emphasize the importance of swift action.

GLS Joins Georgia Partners in Calling for Federal PBM Reform

December 7, 2025
Georgia Life Sciences is proud to stand with patient advocates, providers, and employers across the state in urging Congress to take meaningful action on pharmacy benefit manager (PBM) reform. We recently signed on to a joint letter to Georgia’s Congressional Delegation stressing the urgent need for transparency, fair practices, and policies that ensure savings flow directly to patients.
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