New CMS guidance a “missed opportunity” for future medical innovation, patients

June 30, 2023 | Source BIO.org

The Centers for Medicare & Medicaid Services (CMS) today released its guidance for the Drug Price Negotiation Program (Negotiation Program) under the Inflation Reduction Act of 2022 (IRA). John Murphy, BIO’s Chief Policy Officer, made the following statement: 

Biotechnology Innovation Organization (BIO) logo

“As we have stated in the past, the Medicare price setting provisions of the IRA will have a profound and lasting negative impact on innovative medicine development and access in the US.  Nothing in the final guidance released today will change that. Unfortunately, patients – and their loved ones – will be robbed of the future medical innovation that they’re so desperately waiting for as this law rolls out.  

“CMS took some limited steps in the final guidance that will modestly improve the environment around transparency. Although much more could have been done.  

“Notably, we were pleased to see CMS take the reasonable position of allowing affected manufacturers to control some of their own disclosures and confidentiality protections surrounding the negotiation process.  

“Similarly, CMS clarified the ability of interested parties and patients to have a voice in the negotiation process.  Moreover, Part D plans are now on notice that MFP-selected drugs are going to have to be accessible to patients once negotiated. Although, it remains unclear how much CMS will increase formulary review to ensure unreasonable utilization management is not implemented as a barrier to access.  

“Yet the Agency missed the opportunity to repair damage to the rare disease community and support more meaningful investment in orphan research by allowing new but unapproved orphan designations to retain the orphan exclusion.  We believe CMS has the authority and discretion to make this clarification and to support rare disease patients. 

“BIO and our members will continue to pursue all avenues available to protect patient access to medicines and to ensure the US remains an open market for innovation and investment.”

GLS 2025 Year in Review

December 22, 2025
Dear Georgia Life Sciences Community, As we reflect on the past year, I want to extend my sincere thanks to our Georgia Life Sciences members for making it such an impactful one. Your engagement and leadership continue to move our industry forward and advance our shared strategic priorities— driving strong policy, expanding the talent pipeline, and creating intentional spaces for collaboration across Georgia’s life sciences ecosystem. Our Year in Review captures the progress we’ve made together across these priorities and highlights the collective impact our members are having statewide—from strengthening the workforce and supporting manufacturing growth to elevating Georgia’s position as a national life sciences leader. This progress is only possible because of the collaboration, commitment, and insight of our member community. 

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.
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