US Market Faces Ongoing Ozempic Shortage as FDA Steps In

The United States is grappling with a persistent shortage of Ozempic (semaglutide), Novo Nordisk’s blockbuster diabetes and weight-loss drug, leaving patients and healthcare providers scrambling for solutions. Demand for Ozempic, fueled by its FDA-approved use for Type 2 diabetes and its off-label popularity for weight loss, has outstripped supply since 2022, with the FDA listing it among 277 active drug shortages as of September 2024 [1]. This crisis underscores the challenges within the biotechnology and pharmaceutical sectors, areas where BPO Health excels in providing sourcing and support solutions.

The shortage’s roots lie in unprecedented demand—Ozempic sales reached $13.9 billion globally in 2023, with 65% from the US [2]—coupled with production constraints. Novo Nordisk has struggled to scale manufacturing fast enough, despite investing $6.5 billion to boost capacity. “Supply chain disruptions and raw material scarcity have compounded the issue,” explains Nedo Belucci, Director of North America Operations at BPO Health. “Our sourcing expertise shows how global bottlenecks can delay even the most critical biotech products.”

The FDA has responded proactively. As of October 1, 2024, all Ozempic doses were listed as “available” on the agency’s Drug Shortage Database, signaling progress, though the drug remains officially in shortage until back orders are fully resolved [3]. To bridge the gap, the FDA has allowed compounding pharmacies—both small-scale 503A and larger 503B facilities—to produce semaglutide copies under strict guidelines. However, Novo Nordisk has pushed back, filing over 50 lawsuits against compounders for trademark infringement, highlighting tensions in the market.

For healthcare providers, the shortage has strained patient care. “Diabetes management relies on consistent access to medications like Ozempic,” notes [Insert Nedo Belucci. “BPO Health’s Medtech and pharma support services are designed to mitigate such disruptions.” The FDA continues to collaborate with Novo Nordisk to monitor supply and is exploring further regulatory flexibilities, though no timeline for resolution has been set. As the US market navigates this shortage, BPO Health remains committed to assisting clients with sourcing and operational solutions to ensure continuity of care. Visit www.bpohealth.com to learn more.

[References]

[1] American Society of Health-System Pharmacists (ASHP), Drug Shortages Database, September 2024 (ashp.org)

[2] Novo Nordisk Annual Report 2023 (novonordisk.com)

[3] FDA Drug Shortages Database, October 2024 (fda.gov).