Drug shortages pose a national security risk as well as a danger to public health. That’s the finding from a new report from the U.S. Senate’s homeland security committee.
In 2022, drug shortages hit a five-year peak of 295, with more than 15 critical products in short supply for more than a decade, the report noted.
Shortfalls have included supplies of life-saving drugs such as cancer treatments and emergency room pharmaceuticals as well as common medicines, such as children’s fever-reducers and antibiotics during the 2022 cold-and-flu season.
The report highlighted some key risks in supply chains and regulation, including:
- Geographic concentration in supply for critical drugs and materials, as well as limited domestic manufacturing capabilities, all of which the report framed as a national security risk.
- Unstructured data provided by drugmakers to the Food and Drug Administration means the agency cannot use it in predictive modeling.
- Both the government and industry lack end-to-end visibility into pharmaceutical supply chains.
- The FDA doesn’t have authority to require recalls for most drug products.
Geographically, large numbers of drug and ingredient makers are located in just two countries: China and India.
By 2015, 445 manufacturers of active pharmaceutical ingredients (APIs) were based in China, a more than twofold increase from the five years prior. Meanwhile, India accounted for the majority of FDA-approved API facilities as of 2021, according to research from the nonprofit U.S. Pharmacopeia cited by the Senate committee.
The COVID-19 pandemic has exacerbated shortages, both by increasing the demand for various medications and by pressuring pharmaceutical supply chains. But many of the underlying causes of supply shortfalls trace back to pre-pandemic years.
Among them are the financial incentives to make the drugs. While the costs per drug are often quite low, they require complex manufacturing processes and create barriers to entry for would-be drugmakers, according to the report. Consolidation of the industry has also taken a toll on supply resilience.
The report offered several recommendations for shoring up drug supplies and supply chains, including:
- Investments in advanced manufacturing capabilities for critical drugs through private-public partnerships, and potentially offer long-term government contracts for suppliers of generics.
- Regular government supply chain risk assessments.
- Development of a materials database by the FDA to that can be used to assess risk.
- Give FDA mandatory recall authority for all drug products.