Improving medical product manufacturing capacity and flexibility: new VHA & FDA collaboration

Public health emergency response and other updates from FDA since our last MCMi email include:

• May 23, 2023: FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria 
• May 23, 2023: FDA Roundup including a new collaboration to jointly develop emergency preparedness and response tools and protocols intended to help increase medical product manufacturing capacity and flexibility, and improve resilience of domestic supply chains
• May 22, 2023: FDA Approves Prescription Nasal Spray to Reverse Opioid Overdose
• May 19, 2023: FDA Roundup including announcement of an independent study on challenges in supply, market competition, and regulation of infant formula in the United States
• May 17, 2023: FDA issues two draft guidances for industry to support the approval of pediatric drug products

FDA and the Veterans Health Administration (VHA) announced a new collaboration to jointly develop emergency preparedness and response tools and protocols intended to help increase medical product manufacturing capacity and flexibility, and improve resilience of domestic supply chains during emergencies, shortages, and pandemics.

A new Memorandum of Understanding (MOU) will help facilitate the development of requirements for trusted networks needed to enable the use of distributed manufacturing and digital stockpiles, which could ultimately enable veterans and civilians to more rapidly access innovative medical products to support their care. (May 22, 2023)

Learn more:

• Understanding the terminology of these advanced manufacturing approaches 
• Advanced manufacturing news & events

FDA approved Xacduro (sulbactam for injection; durlobactam for injection), a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex, for patients 18 years of age and older.

According to the World Health Organization, Acinetobacter species top the list of critical bacterial pathogens that pose the greatest threat to human health, highlighting the high level of need for additional treatment options amid growing global resistance to antimicrobial medicines. (May 23, 2023)  

FDA issued two draft guidances for industry:

• Pediatric Drug Development: Regulatory Considerations – Complying with PREA and Qualifying for Pediatric Exclusivity Under the BPCA  (Federal Register notice)
• Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Consideration  (Federal Register notice)

Both guidances, once finalized, will provide recommendations to support the assessment of pediatric drugs, biological products, and vaccines under the Pediatric Research Equity Act (PREA) and/or the Best Pharmaceuticals for Children Act (BPCA). The guidance documents revise and replace the draft guidance for industry How to Comply with the Pediatric Research Equity Act. Comments on both draft guidances are due by July 17, 2023 (see Federal Register notices linked above). Learn more (May 17, 2023)

Quick COVID-19 resources

• Check expiration date extensions for your COVID-19 tests 
• Get the latest on COVID-19 vaccines
• Know your treatment options for COVID-19

What happens to EUAs when a public health emergency ends? There are several types of declarations and determinations related to emergencies, including public health emergencies, which serve different purposes. Learn more in this FAQ. Also see, from HHS, Fact Sheet: End of the COVID-19 Public Health Emergency

List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 450 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and learn more about safely using hand sanitizer.