Patients will suffer because of this bureaucratic and unnecessary second-guessing of the FDA, says BIO CEO.

Dr. Michelle McMurry-Heath, President and CEO of the Biotechnology Innovation Organization (BIO), released the following statement in response to the Centers for Medicare and Medicaid Services’ (CMS’s) National Coverage Determination (NCD) to restrict coverage for drugs used to treat patients suffering from Alzheimer’s Disease:

“The National Coverage Determination released this evening by CMS is an enormous setback for Alzheimer’s patients and an unprecedented and dangerous infringement on the FDA’s scientific autonomy and decision making.

“With this decision, CMS is not just saying it has no confidence in Alzheimer’s drugs approved under the FDA’s Accelerated Approval pathway. It also is undermining confidence in FDA’s traditional drug approval process more broadly.

“CMS will now subject these Alzheimer’s drugs approved under the Accelerated Approval pathway to cumbersome, expensive and time-consuming new trials that will delay and limit access. Even access to products approved under the traditional process by FDA will be significantly limited for patients while they wait for a government agreement to set up CMS-approved registries, which history tells us takes years to establish.

“Patients will suffer because of this bureaucratic and unnecessary second-guessing of the FDA. CMS is chasing innovators out of this critical field and devastating future investment and research going toward treating patients with Alzheimer’s.

“As we have said from the outset, CMS does not have the scientific expertise to do this critical work. While FDA has thousands of experienced scientists and clinicians, CMS has less than 30. FDA staffers are scientifically trained at judging the benefit and risk of all kinds of therapies and have a long history of collaboration with the scientific, patient and academic communities. CMS is not equipped to make these judgments, and today’s decision is a dangerous rebuke of the FDA’s hard-earned scientific prowess.

“In the end, CMS has actually made its initial proposal far worse and expanded the damage it will cause to many more patient populations and their loved ones.”

Georgia Life Sciences Designates City of Atlanta as Newest BioReady® Community

By Sheran Brown • February 21, 2025
Georgia Life Sciences Designates City of Atlanta as Newest BioReady® Community

Bipartisan PBM Reform Back in Focus as House Committee Plans Hearing

By Sheran Brown • February 20, 2025
A renewed push for prescription drug cost reform is gaining momentum in Congress, with the House Energy and Commerce Committee's health subcommittee planning a hearing on pharmacy benefit manager (PBM) reform for late February. The hearing, to be led by Rep. Buddy Carter (R-Ga.), signals a revival of bipartisan efforts to regulate these pharmaceutical intermediaries. PBMs, which negotiate drug prices for insurers and employers, have become a focal point in the broader discussion of healthcare costs. A previous bipartisan agreement to regulate these entities was crafted by Carter and Rep. Diana DeGette (D-Colo.) in the last Congress, though it ultimately stalled when the larger spending bill it was attached to faced opposition. The reform efforts enjoy broad support from both parties and the president, making it one of the few areas with potential for bipartisan cooperation. However, new complications have emerged as Republicans consider using PBM regulations to generate savings for their broader policy agenda, potentially requiring up to $880 billion in cost reductions. The path forward remains uncertain, with ongoing debates about whether such reforms would qualify for budget reconciliation and whether using PBM regulations as a funding mechanism could derail bipartisan cooperation. Meanwhile, stakeholders continue to disagree on the impact of additional PBM regulation, with pharmaceutical companies arguing that PBMs inflate drug costs while PBMs contend that new regulations would increase prices.

Council on State Biotechnology Associations says NIH funds are a critical component of innovation ecosystem

By Sheran Brown • February 20, 2025
The Council of State Biotechnology Associations (CSBA) has issued a strong warning about proposed cuts to National Institutes of Health (NIH) funding, emphasizing the critical role these grants play in America's biotech innovation ecosystem. The statement, below , comes amid concerns over recent guidance that would reduce NIH funding to key research institutions. ----------------------- “Today, the US biotech industry employs nearly 2.3 million people across the US and is making positive contributions to economic impact and national security across all 50 states. In fact, for every dollar the National Institutes of Health (NIH) contributes to a successful drug, the private sector invests over $65, underscoring the agency’s unparalleled return on investment. As the associations representing the bioscience industry across the nation, the Council on State Biotechnology Associations (CSBA) is concerned by recent guidance that would cut funding provided by the NIH to universities, hospitals, and other institutions that perform critical early-stage research. NIH grant funds are a critical component of our innovation ecosystem. Grants for basic research are the spark that leads to university-driven discoveries, with public-private partnerships and tech transfers that bridge early-stage research to industry-sponsored drug development and ultimately to FDA approved medical advances for hundreds of diseases. While the administration looks for greater efficiency in the use of taxpayer dollars, it cannot be overstated - once scientific innovation moves abroad, it may never return. In the race for scientific innovation around the world, as our adversaries continue to increase government investments in research, we encourage President Trump to follow suit and ensure that we maintain our global leadership in an industry that was created and thrives across the US.”
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