FDA authorizes new long-acting monoclonal antibody for pre-exposure prevention of COVID-19 | New AI paper | Drug shortage updates

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

• March 29, 2024: Questions and Answers Regarding Milk Safety During Highly Pathogenic Avian Influenza (HPAI) Outbreaks
• March 28, 2024: FDA Principal Deputy Commissioner Dr. Namandjé N. Bumpus has launched a new video series, FDA In Your Day. The first video covers measles vaccines, drug shortages, AI, and FDA-approved products for two rare diseases.
• March 26, 2024: FDA Warns Consumers to Avoid Certain Topical Pain Relief Products Due to Potential for Dangerous Health Effects
• March 22, 2024: FDA's Center for Drug Evaluation and Research (CDER) established a new Quantitative Medicine Center of Excellence.
• March 11, 2024: FDA Seeks $7.2 Billion to Enhance Food Safety and Nutrition, Advance Medical Product Safety, and Strengthen Public Health
• March 5, 2024: FDA is accepting proposals for FY 2024-2025 funding opportunities to collect data on antimicrobial use in animals. 
• March 5, 2024: Use of Trivalent Influenza Vaccines for the 2024-2025 U.S. Influenza Season
• March 1, 2024: Consumer Update: Vaccination Is the Best Protection Against Measles  
• March 2024: The HHS Office of Long COVID Research and Practice published an update: Implementation of the Government-wide Response to Long COVID (PDF)

More FDA press announcements

FDA issued an Emergency Use Authorization (PDF) for Pemgarda (pemivibart) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescents (12 years of age and older weighing at least 40 kilograms [about 88 pounds]).

Pemgarda is authorized for individuals:

• who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2;
• and who have moderate-to-severe immune compromise due to a medical condition or due to taking immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination.

More information:

• Fact sheet for health care providers (PDF)
• Fact sheet for patients (PDF)
• Frequently Asked Questions on the EUA for Pemgarda (pemivibart) for Pre-exposure Prophylaxis (PrEP) of COVID-19 (PDF)
• Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products

New public portal

FDA launched a new portal for patients, consumers, and health care professionals to report potential drug shortage issues directly into CDER’s NextGen system without creating a NextGen account. (March 18, 2024)

HHS releases white paper focused on preventing drug shortages 

The U.S. Department of Health and Human Services (HHS) released a white paper, Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States, highlighting steps HHS has taken to prevent and mitigate drug shortages and proposing additional solutions for policymakers to consider. 

FDA recognizes that a robust, resilient and safe drug supply chain is essential for public health and national security. We remain committed to partnering across government, academia, and industry to strengthen and diversify the supply chain, further address drug shortages and ensure Americans continue to have access to drugs that are of high quality, safe and effective. (April 2, 2024) 

Paxlovid (nirmatrelvir and ritonavir) labeled with EUA packaging is no longer authorized for use

EUA-labeled Paxlovid is no longer authorized for emergency use, regardless of the labeled or extended expiration date. For both NDA-approved and EUA-authorized uses, only NDA-labeled Paxlovid may be dispensed. Today’s revision to the Paxlovid EUA completes FDA’s transition to FDA-approved Paxlovid from EUA-labeled Paxlovid.

The Paxlovid EUA (PDF, revised March 13, 2024) continues to authorize:

• Emergency use of NDA-labeled Paxlovid for the treatment of mild-to-moderate COVID-19 in pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death; and
• Prescribing Paxlovid for an individual patient by a state-licensed pharmacist for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death, subject to certain conditions.

All EUA-labeled Paxlovid, including expired EUA-labeled Paxlovid, remaining in U.S. distribution must be returned to the manufacturer or disposed of in accordance with all federal, state, and local regulations.  

Through December 31, 2024, eligible patients qualify for free Paxlovid through the PAXCESS program.  Eligible patients include Medicare beneficiaries, Medicaid beneficiaries, and uninsured individuals who do not have a prescription drug benefit at the time they fill their prescription. Patients who are commercially insured may be eligible for assistance though a co-pay savings program. 

For more information, see: FDA revises letter of authorization for the emergency use authorization for Paxlovid. 

New mpox diagnostic EUAs

On March 22, 2024, FDA authorized two new molecular diagnostic tests for mpox. 

EUA quick links

• Emergency Use Authorization - about EUAs, and links to current EUAs
• EUAs for Drugs and Non-Vaccine Biological Products (CDER)
• EUAs for Medical Devices (CDRH)
• COVID-19 Vaccines, including vaccine-specific pages with EUA info (CBER)
• Emergency Use Authorization--Archived Information - EUAs that are no longer in effect because they have been terminated or revoked
• Historical Information about Device EUAs

Expiration date extension

Did you know? You can find information about shelf-life extensions of COVID-19 vaccines, therapeutics, and in vitro diagnostic (IVD) tests, and other medical countermeasures, on our web page: Expiration Dating Extension, under MCM Expiration Dating Extensions.

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 650 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.

Q&A with FDA podcast
In this podcast series, FDA’s Division of Drug Information answers some of the most commonly asked questions received by FDA. Previous episodes include conversations about drug shortages, expanded access, avoiding medication scams, and much more.