USP supply chain map provides ‘early warning’ of possible drug shortages

Regulatory NewsRegulatory News
| 22 March 2022 | By Joanne S. Eglovitch 

The US Pharmacopoeia (USP) has released a medicine supply map that aims to build visibility into the upstream supply chain and identify which active pharmaceutical ingredients (API) used in medicines are vulnerable to shortages.
The USP map uses information from 40 data sets from public and private sources to identify global sites of manufacturing. This data is then supplemented with information on risk drivers, such as price, manufacturing locations, chemical information, dosage form and quality to predict a drug’s risk of going into shortage. The map also tracks orders for where USP’s reference standards are sold. Altogether, the pharmacopeia says the map includes 250 million aggregated data points on risk indicators.
“Medicines that are made in more places tend to have more secure supply chains,” Vimala Raghavendran, senior director of the USP pharmaceutical supply chain center, told Focus. For example, antibiotics are primarily manufactured in China, meaning that these drugs are more susceptible to shortages than drugs made in more geographically diverse locations.
The map shows that India is overwhelmingly the largest supplier of APIs to the U.S., with 183 facilities that make ingredients for 10 or more US-approved API products and 114 facilities with more than 30 approved API products.
Europe is the next largest supplier with 45 facilities that produce more than 30 API products destined for the US market and 83 facilities that make more than 10 approved API products, followed by China, which has four facilities making ingredients for more than 30 approved products, and 35 facilities making ingredients for more than 10 products. The US is at the low end of the list, with three facilities making ingredients for more than 30 US approved products and 19 making ingredients for more than 10 US-approved API products.
Raghavendran said the map builds on other recent efforts to address drug shortages, such as the National Academies of Science, Engineering and Medicine (NASEM) report on supply chain resilience, which recommends that FDA publicly disclose information on drug and medical device sourcing, manufacturing and volume. (RELATED: NASEM report: FDA should disclose drug and device manufacturing information, Regulatory Focus 4 March 2022)
“What we’re finding … is that you need to diagnose the problem before you identify the solution. The NASEM report said that it can’t be just one thing. You have to identify what is driving the vulnerability of the drug before you identify the cure,” she said.
The map is designed to serve as an “early warning system to help identify ingredient and finished product at risk of shortages so providers, manufacturers, and governments can take actions to help prevent the shortage form occurring,” said USP CEO Ronald Piervincenzi. “Without visibility into the medicine supply chain, preparing for the next crisis is not possible.”
Even before the pandemic, which stressed the global medical supply chain, policymakers and FDA have raised concerns about the US pharmaceutical industry’s dependence on foreign-made APIs. At a House hearing in 2019, then-Center for Drug Evaluation and Research (CDER) Director Janet Woodcock expressed reservations about the overreliance on APIs sourced from overseas, noting that 28% of the manufacturing facilities making APIs for the US market were located in the US, and the remaining 72% were in other countries.
And in the Senate, health committee members this month overwhelmingly voted to advance the Prepare for and Respond to Existing Viruses, Emerging New Threats and Pandemics Act (PREVENT Pandemics Act) that would in part strengthen the pharmaceutical supply chain by bolstering the US Strategic National Stockpile (SNS) and ensuring registration of foreign drug manufacturers. (RELATED: Senate committee advances pandemic bill packed with FDA-related provisions, Regulatory Focus 16 March 2022)


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you