BIO Statement On Selected Drugs in Medicare under Inflation Reduction Act

The Biotechnology Innovation Organization (BIO) released the following statement after today’s announcement from the Centers for Medicare & Medicaid Services (CMS) on selected drugs under the Inflation Reduction Act (IRA):

“While the Inflation Reduction Act puts a cap on senior’s out-of-pocket costs, it also contained some very damaging parts that will impede the development of newer and better medicines for all. Important aspects of the IRA are also damaging to the critical role of the United States and our allies to remain the centers of excellence in biotechnology worldwide. With today’s announcement, we see the start of unilateral government mandated price controls. This will inevitably lead the U.S. on a path to higher costs for patients and less access to innovative medicines. 



“The lack of transparency and a scientific approach to decision-making throughout this process undermines the value that these medicines bring to patients in the U.S and around the globe. We are also just beginning to see the harm to patients caused by the unintended consequences of penalizing medicines made as pills. The IRA also includes a damaging provision that will curtail the development of medicines for multiple rare genetic diseases.


“At the same time, Congress and the administration must turn their full attention to health insurers and middlemen who profit by denying Medicare patients and others access to the medicines that their doctors prescribe. This is the source of high costs at the pharmacy and the denial of access to lifesaving treatments and cures. Delay and denial from health insurance companies equals suffering and death. This must be addressed, as well as correcting the most egregious parts of the IRA.”

August 21, 2026
Genetic Engineering & Biotechnology News (GEN) has named Georgia #4 among its “Next 5 States” for emerging U.S. biopharma clusters . The article highlights UCB’s planned $2 billion investment at in Gwinnett County, Micron Biomedical’s new Alpharetta facility, Manus Bio’s expansion in Augusta, Science Square, Emory University, the CDC — and Georgia Life Sciences’ 10-year Life Sciences Roadmap . This recognition is exciting. But even more importantly, it validates the work happening across our entire ecosystem — and perfect momentum as we head into the 2026 Georgia Life Sciences Summit next week. Read more by visiting: Next 10 U.S. Biopharma Clusters
August 17, 2026
Biotechnology Innovation Organization (BIO) Senior Vice President of Science & Regulatory Affairs Annetta Beauregard issued the following statement on the release of the Prescription Drug User Fee Act (PDUFA) VIII commitment letter: “For more than 30 years, PDUFA has helped deliver hundreds of new medicines to American patients. As a lead industry negotiator for the PDUFA VIII agreement, BIO supports the PDUFA VIII commitment letter and its strengthening of regulatory review, advancing innovation, and helping deliver safe and effective treatments to patients. “Specifically, the PDUFA VIII agreement includes important commitments that bolster the FDA’s core review activities, ensure accountability for predictable performance, improve financial sustainability and improve communication, transparency and efficiency. “Timely, bipartisan reauthorization of PDUFA is vital for protecting the health of Americans, strengthening U.S. competitiveness, and maintaining America’s global leadership in medical innovation. BIO is committed to working with Congress to ensure reauthorization by September 30, 2027.” The FDA has announced plans to hold a hybrid public meeting at 9am on 9/16 to discuss the proposed enhancements for the reauthorization of PDUFA for fiscal years (FYs) 2028 through 2033. Learn More about PDUFA and the PDUFA VIII commitment letter HERE .
August 17, 2026
Representing Georgia’s life sciences community, GLS emphasized the importance of advancing policies that improve affordability and patient access while preserving the environment necessary for continued biomedical innovation. In its comments, GLS urged CMS to maintain a framework grounded in FDA regulatory determinations and raised concerns about how certain proposed policies could affect post-approval research and development, investment in new indications, and patient access to innovative therapies. GLS also encouraged CMS to consider the broader implications for healthcare delivery, including the potential impact on patients and providers in rural and underserved communities. As federal drug pricing policy continues to evolve, Georgia Life Sciences will continue to advocate for approaches that balance affordability, access, and innovation while ensuring Georgia’s life sciences community has a voice in the policymaking process. Read Georgia Life Sciences’ full comments to CMS ( click here ).
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