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: 

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“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.”

Georgia’s Life Sciences Momentum is Getting Noticed Nationally.

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

BIO Supports PDUFA VIII Commitment Letter and Urges Timely Reauthorization

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 .

Georgia Life Sciences Submits Comments on Medicare Drug Price Negotiation Program

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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