Biden Admin Boosts Pharma Supply Chain Amid FDA Alzheimer’s Drug Approval
The Biden Administration aims to improve the pharmaceutical supply chain, reducing US reliance on global supply while FDA approves novel Alzheimer’s drug and CMS announces navigator funding.
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By - In an effort to reduce the US reliance on the global pharmaceutical supply chain, the Biden Administration accepted recommendations for improving the US supply chain. Meanwhile, the FDA approved a first-of-its-kind Alzheimer’s drug, and CMS announced funding for navigators.
G7 Summit Addresses COVID-19 Pandemic, Future Global Preparedness
HHS Secretary Xavier Becerra joined other leaders from G7 countries to discuss the future of global health security. The summit emphasized the One Health approach for global surveillance that looks at the impact of people, animals, plants, and shared environments on emerging infectious diseases. Secretary Becerra articulated his support for the approach to prevent, detect, and respond to outbreaks in addition to the development of novel antibiotics for the treatment of disease. He also highlighted the US successes in telehealth expansion during the pandemic. READ MORE
HHS Funds Program to Improve Access to Affordable Water Services
HHS, through the Administration for Children and Families (ACF), announced funding for the Low-Income Household Water Assistance Program. The program aims to expand access to affordable water and assist households impacted by the COVID-19 pandemic to pay water bills and avoid shutoffs. A total of $1.1 billion will be made available through program grants to support these efforts. READ MORE
CMS Announces Navigator Funding for Federally-Facilitated Marketplaces
On June 4, CMS announced $80 million in funding for navigators in states with federally-facilitated marketplaces. This is the largest funding CMS has made available to navigators to date. These professionals play a critical role in the education, outreach, and enrollment of individuals for insurance coverage, and CMS emphasized the importance of navigators to reach those in underserved and vulnerable communities. READ MORE
FDA Approves Novel Alzheimer’s Drug
The FDA approved Aduhelm (aducanumab) for the treatment of Alzheimer’s under an accelerated approval pathway. This process, different from the traditional approval process, accepts that the therapeutic has shown a meaningful benefit in clinical trials even though the final desired outcomes has not been achieved yet. The approval comes with a provision that Biogen, the founding company, conduct a new randomized, controlled trail to verify the clinical benefit. Aduhelm is the first drug to target the underlying pathophysiology of Alzheimer’s disease. READ MORE
Biden Administration Accepts Recommendations for Improved Pharmaceutical Supply Chain
Yesterday, the Biden Administration accepted the FDA and HHS Office of the Assistant Secretary for Preparedness and Response’s recommendations for improving the pharmaceutical supply chain. According to the HHS press release, there are four key pillars necessary to secure the supply chain and reduce the US reliance on the global supply chain:
- Boosting local production and fostering international cooperation
- Promoting research and development that establishes innovative manufacturing processes and production technologies to strengthen supply chain resilience
- Creating robust quality management maturity to ensure consistent and reliable drug manufacturing and quality performance
- Leveraging data to improve supply chain resilience
The success of the efforts will require support from multiple government agencies starting with an HHS commitment of $60 million to bolster platform technologies that increase domestic manufacturing capacity. READ MORE
