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With the first announced drug shortage tied to the coronavirus outbreak, FDA emphasizes urgency for monitoring drug supply chain.
FDA has issued its first announcement of a drug shortage related to the COVID-19 coronavirus outbreak in a Feb. 27, 2020 statement on the drug supply chain. An unnamed drug manufacturer has alerted FDA of a shortage of a human drug due to an issue with the manufacture of an API used in the drug. The drug has been added to FDA’s drug shortages list.
“It is important to note that there are other alternatives that can be used by patients,” FDA noted in the statement. “We are working with the manufacturer as well as other manufacturers to mitigate the shortage. We will do everything possible to mitigate the shortage.”
The agency has identified approximately 20 drugs that solely source APIs or finished drug products from China and has contacted the firms to assess the potential for shortages.
Drug companies have legal obligations to inform FDA of potential supply chain disruptions. The FDA statement said the agency has reminded 180 human drug manufacturers of these requirements and asked them to evaluate their supply chains for any APIs and other ingredients manufactured in China.
Animal drug manufacturers have not reported shortages as of Feb. 27, 2020, FDA reports. However, six of the 32 firms that source materials from China have indicated supply chain disruptions that could lead to shortages. FDA said it is working with these firms to mitigate potential shortages.
In its supply chain update, FDA said that while the agency “is using all our existing authorities to address COVID-19, and we welcome the opportunity to work with Congress to further strengthen our response capabilities and emergency preparedness,” citing proposals in the President’s budget that would “better equip the FDA to prevent or mitigate medical product shortages.”
The proposals include the following:
Lengthen the expiration dates of critical drugs. FDA seeks the authority to require drug applicants to evaluate, submit studies to FDA, and label a product with the longest possible expiration date that FDA agrees is scientifically justified, to alleviate a potential drug shortage.
Require risk management plans. Under this proposal, FDA would require certain drug application holders to conduct periodic risk assessments of vulnerabilities in their manufacturing supply chain-including contract manufacturing facilities-and develop plans to mitigate these risks associated.
Require more accurate supply chain information. FDA is proposing gathering information to assess critical infrastructure and manufacturing quality and capacity would facilitate supply chain monitoring and improve the agency’s ability to recognize shortage signals.