FDA lays out framework for manufacturers and developers to tackle drug shortages

While the FDA says it has eased or thwarted “hundreds of new drug shortages” in the U.S. over the past 10 years, quality problems, global supply chain weaknesses, unexpected demand spikes, market withdrawals and natural disasters continue to threaten the nation’s stock of pharmaceuticals.

To that end, the regulator unveiled new draft guidance Thursday to help manufacturers forge risk management plans aimed at combating drug shortages. 

Under the agency’s guidance, manufacturers of certain drugs and drug ingredients would be required to implement risk management plans. For others, the move is simply recommended.

The move follows a 2019 report from the federal Drug Shortages Task Force angling for the adoption of such plans, plus the Coronavirus Aid, Relief, and Economic Security Act—passed by Congress in in 2020—which calls on certain manufacturers to plan ahead to prevent shortages.

In its guidance, FDA is mandating risk management plans for medicines used to treat rare diseases, drugs that lack “appropriate alternatives” and medical countermeasures against public health emergencies.

Makers of sole-source products should also consider implementing risk assessment plans, the FDA said, as should manufacturers of drugs with just one active pharmaceutical ingredient source in their supply chain.

Drug shortages hit a peak in 2011 and dropped to a low point in 2015 and 2016. Unfortunately, however, “this downward trend did not continue in subsequent years,” the FDA said in its guidance. Drug shortages have grown “more persistent” and continue to occur “at roughly the same levels since 2018,” the agency explained.

Aside from quality issues, supply chain disruptions and unexpected spikes in demand for certain products have triggered shortages, the agency notes. It's also "increasingly concerned" about cyberattacks hampering the pharma supply chain.

The agency is giving drug companies 60 days to submit comments and suggestions on the FDA’s guidance.

Supply chain management has been top of mind for the industry—and regulators—over the past two years as the COVID-19 pandemic cast a spotlight on Europe and the U.S.’ fragmented drug ingredient networks plus tight demand for raw materials such as those used to make coronavirus vaccines.

As for the how the industry itself is looking to tackle disruptions, manufacturing executives from Catalent, Alnylam, Amgen, Sandoz and Bayer sat down virtually with Fierce Pharma earlier this year to share pandemic lessons learned.

Amgen, for its part, said its guiding principles for supply chain resilience over the past two years have been to focus on infrastructure, cybersecurity, digitization, business continuity and inventory.

Another way to mitigate supply chain disruptions? Simplify, said Kevin Cook, Sandoz’s vice president of supply chain for North America. When manufacturers have a smaller surface area—defined as the sum of all products, processes and networks that make up the supply chain—"you can manage the disruption more effectively,” Cook said.

Meanwhile, resource tensions don’t seem to be easing any in 2022. Germany’s Merck KGaA earlier this month warned that renewed COVID-19 lockdowns in China and Russia’s war in Ukraine have put a further squeeze on global supply chains and prompted a spike in operational costs. To ease potential shortages and price hikes, Merck KGaA says it will rely on higher stockpiles for critical raw materials and actively keep tabs on its supply base. Further, the Darmstadt, Germany-based drugmaker says it will leverage production sites outside of lockdown-affected areas “wherever possible.”