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# Only 20 Drugs on ‘Virus’ Watch, Not 150: Hahn
- URL: https://www.fdaweb.com/only-20-drugs-on-virus-watch-not-150-hahn/
- Published: 2020-02-26T12:00:00.000Z
- Updated: 2026-09-14T16:04:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146178

FDA commissioner **Stephen Hahn** says media reports ([see earlier story](https://www.fdaweb.com/150-drugs-on-virus-related-shortage-watch-list-fda/)) are wrong about the agency monitoring 150 prescription drugs that could be in short supply if plants in China that make their active pharmaceutical ingredients are restricted from manufacturing or distributing products due to the recent coronavirus outbreak. “We are reaching out to manufacturers and compiling information about the supply chain at this time, but that report does not accurately reflect our current assessment,” Hahn said in his [Twitter feed](https://twitter.com/SteveFDA/status/1232456471188623363?ref=fdaweb.com). “No firms are reporting drug shortages due to \[the coronavirus\], including the approximately 20 drug products that are solely sourced from China.”  

An FDA spokeswoman told ***FDA Webview*** that the agency “has been reaching out to over 180 manufacturers and reminding them of their requirement to notify FDA of any anticipated supply disruptions. In addition, we have asked them to evaluate their entire supply chain, including active pharmaceutical ingredients and other components manufactured in China.”

In a recent [statement](http://FDA commissioner Stephen Hahn says media reports %28see earlier story%29 are wrong about the agency monitoring 150 prescription drugs that could be in short supply if plants in China that make their %28XXX SUBSTITUTE XXX%29 active pharmaceutical ingredients are restricted from manufacturing or distributing products due to the recent coronavirus outbreak. “We are reaching out to manufacturers and compiling information about the supply chain at this time, but that report does not accurately reflect our current assessment,” Hahn said in his Twitter feed. “No firms are reporting drug shortages due to [the coronavirus], including the approximately 20 drug products that are solely sourced from China.” %28XXX CLOSE QUOTE XXX%29     An FDA spokeswoman told FDA Webview that the agency “has been reaching out to over 180 manufacturers and reminding them of their requirement to notify FDA of any anticipated supply disruptions. In addition, we have asked them to evaluate their entire supply chain, including active pharmaceutical ingredients and other components manufactured in China.”     In a recent statement, %28XXINSERT LINKXX%29 Hahn said that while a U.S. State Department ban on travel to China prevents it from conducting inspections there, “this is not hindering our efforts to monitor medical products and food safety. We have additional tools we are utilizing to monitor the safety of products from China, and in the meantime, we continue monitoring the global drug supply chain by %28XXX DELETE EXTRA SPACE XXX%29prioritizing risk-based inspections in other parts of the world.”     Hahn said FDA’s %28XXX SUBSTITUTE, DELETE XXX%29other tools in lieu of China inspections include %28XXX INSERT, DELETE XXX%29 “import screening, examinations, sampling, and import alerts, relying on a firm’s previous compliance history, and we use information from foreign governments as part of mutual recognition agreements. Thus, at this time, we can rely on these other tools to give us comprehensive oversight of FDA-regulated products entering this country. This is all part of our agency’s risk-based approach to ensuring quality, as well as compliance with applicable FDA requirements.” He also said FDA will request records from firms it %28XXX SUBSTITUTE XXX%29has concerns with in China until inspections are allowed to resume.     Meanwhile, FDA recently helped expedite a National Institutes of Health %28XXX DELETE XXX%29 randomized controlled trial %28XXX INSERT SPACE XXX%29for a coronavirus treatment. “While sponsors are usually expected to allow 30 days between submission and initiation of an initial IND protocol to allow for safety review, FDA has been using both pre-IND discussions and highly expedited initial review to allow such trials to begin as soon as possible,” the agency said. “We continue to work with interested sponsors to help expedite any additional clinical trials for COVID-19 medical countermeasures that may be appropriate.”), Hahn said that while a U.S. State Department ban on travel to China prevents it from conducting inspections there, “this is not hindering our efforts to monitor medical products and food safety. We have additional tools we are utilizing to monitor the safety of products from China, and in the meantime, we continue monitoring the global drug supply chain by prioritizing risk-based inspections in other parts of the world.”

Hahn said FDA’s other tools in lieu of China inspections include “import screening, examinations, sampling, and import alerts, relying on a firm’s previous compliance history, and we use information from foreign governments as part of mutual recognition agreements. Thus, at this time, we can rely on these other tools to give us comprehensive oversight of FDA-regulated products entering this country. This is all part of our agency’s risk-based approach to ensuring quality, as well as compliance with applicable FDA requirements.” He also said FDA will request records from firms it has concerns with in China until inspections are allowed to resume.

Meanwhile, FDA recently helped expedite a National Institutes of Health [randomized controlled trial](https://www.niaid.nih.gov/news-events/nih-clinical-trial-remdesivir-treat-covid-19-begins?ref=fdaweb.com) for a coronavirus treatment. “While sponsors are usually expected to allow 30 days between submission and initiation of an initial IND protocol to allow for safety review, FDA has been using both pre-IND discussions and highly expedited initial review to allow such trials to begin as soon as possible,” the agency said. “We continue to work with interested sponsors to help expedite any additional clinical trials for COVID-19 medical countermeasures that may be appropriate.”  
  
And Moderna said it has shipped to NIH’s National Institute of Allergy and Infectious Diseases the first batch of its investigational coronavirus vaccine mRNA-1273 for use in a planned Phase I study. mRNA-1273 is an mRNA vaccine against the novel coronavirus encoding for a [prefusion stabilized](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.niaid.nih.gov%2Fnews-events%2Fatomic-structure-novel-coronavirus-protein&esheet=52178772&newsitemid=20200224005955&lan=en-US&anchor=prefusion+stabilized&index=1&md5=7c7b0994038c62b631b3adeb8c75591c&ref=fdaweb.com) form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators at NIHֺ’s Vaccine Research Center. The study, “Safety and Immunogenicity Study of 2019-nCov Vaccine (mRNA-1273) to Treat Novel Coronavirus” ([NCT04283461](https://clinicaltrials.gov/ct2/show/NCT04283461?ref=fdaweb.com)), was also disclosed by NIH on *ClinicalTrials.g*ov.