As Drug Shortages Rise, Pharma Supply Chain Poses Risks

Drug shortages endanger national security as well as public health. This is the conclusion of a new report from the United States Senate’s Homeland Security Committee.

As per the report, medicine shortages reached a five-year high of 295 in 2022, with more than 15 vital products in short supply for over a decade.

There were shortages of life-saving prescriptions such as cancer therapies and emergency department pharmaceuticals, as well as basic medicines such as children’s fever controllers and antibiotics, during the 2022 cold and flu season.

The report highlighted the following main concerns in supply chains and regulation:

• The report portrayed the geographic concentration of supply for vital medications and commodities, as well as restricted domestic manufacturing capabilities, as a national security issue.
• The FDA cannot make use of unorganized data provided by drugmakers since it will not be used in predictive modelling.
• Both the government and businesses lack end-to-end transparency in pharmaceutical supply networks.
• The FDA lacks the authority to order recalls of most pharmaceuticals.

Geographically, the majority of medication and ingredient manufacturers are concentrated in just two countries: China and India.

By 2015, China had 445 active pharmaceutical ingredients (API) factories, a twofold increase over the previous five years. Meanwhile, according to statistics cited by the Senate committee from the nonprofit U.S. Pharmacopeia, India accounted for the bulk of FDA-approved API facilities as of 2021.

The COVID-19 pandemic has worsened shortages by raising demand for various drugs while also putting strain on pharmaceutical supply networks. Yet, many of the root causes of supply shortages may be traced back to pre-pandemic years.

Among them are financial incentives for medication production. According to the study, while the prices per medicine are typically fairly cheap, they necessitate sophisticated production methods and create obstacles to entry for would-be drugmakers. Industry consolidation has also had an impact on supply resilience.

Many recommendations were made in the report to bolster drug supplies and supply chains, including:

• Investments in enhanced manufacturing capacities for key medications through public-private partnerships, with the prospect for long-term government contracts for generics providers.
• Routine government supply chain risk evaluations.
• Creating a materials database that can be used to determine risk by the FDA.
• Give the FDA obligatory recall authority over all pharmaceutical items.