In this week’s news, the Whitehouse announced plans to make US API supply chains more robust, US FDA tweaks EUA for Pfizer’s COVID-19 vaccine and more…
US moves to make API and drug supply chains more robust
US President Joe Biden has said he wants to make the country’s API and drug supply chains “resilient, diverse, and secure,” citing economic and national security.
The plan was outlined in an executive order issued by the Whitehouse this week.
The order tasks the Secretary of Health and Human Services with compiling a report “identifying risks in the supply chain for pharmaceuticals and active pharmaceutical ingredients and policy recommendations to address these risks.”
Like orders issued by the previous administration, the new document identifies increasing domestic production as a key goal.
It states, “More resilient supply chains are secure and diverse — facilitating greater domestic production, a range of supply, built-in redundancies, adequate stockpiles, safe and secure digital networks, and a world-class American manufacturing base and workforce. “
The Association for Accessible Medicines welcomed the order.
The latter organisation told Drug Store News it is a “prudent, considered approach to fully understanding the scope and capacity of current US pharmaceutical manufacturing.”
US Oks shipment of Pfizer COVID-19 vaccine at higher temp
The US FDA said it will let Pfizer and Biontech’s SARS-CoV-2 transport their COVID-19 vaccine at temperatures found in conventional pharmaceutical freezers.
Last week Pfizer and BioNTech submitted data showing the vaccine is stable at higher temperatures based on manufacturing data.
EDQM to implement revised sartan monographs by April
The European Directorate for the Quality of Medicines (EDQM) will implement new sartan monographs that were adopted through its new “rapid revision procedure” on 1 April.
The monographs make clear how producers must assess the risk N-nitrosamine – a carcinogenic contaminant found in some drugs containing the API – will be formed during manufacturing.
The also specify how, if a risk is identified, manufacturers should go about changing processes to minimise potential contamination.