Coronavirus (COVID-19) Update: Daily Roundup

SILVER SPRING, Md., March 30, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

    --  On March 28, 2020, the FDA issued an Emergency Use Authorization (EUA)
        to allow hydroxychloroquine sulfate and chloroquine phosphate products
        donated to the Strategic National Stockpile (SNS) to be distributed and
        used for certain hospitalized patients with COVID-19. These drugs will
        be distributed from the SNS to states for doctors to prescribe to
        adolescent and adult patients hospitalized with COVID-19, as
        appropriate, when a clinical trial is not available or feasible. The EUA
        requires that fact sheets that provide important information about using
        chloroquine phosphate and hydroxychloroquine sulfate in treating
        COVID-19 be made available to health care providers and patients,
        including the known risks and drug interactions. The SNS, managed by
        ASPR, will work with the Federal Emergency Management Agency (FEMA) to
        ship donated doses to states.


    --  On March 29, 2020, the FDA issued an immediately in effect guidance that
        outlines an enforcement policy to help expand the availability and
        capability of sterilizers, disinfectant devices and air purifiers. The
        devices include those intended to make devices sterile, kill pathogens
        or other microorganisms and kill pathogens or microorganisms in the air.
        This policy reflects FDA's commitment to ease burdens on health care
        providers and facilities as they face COVID-19.


    --  The FDA amended the Emergency Use Authorization (EUA) for the Battelle
        Decontamination System for use in decontaminating compatible N95
        respirators for reuse by health care personnel during the COVID-19
        pandemic. This EUA is an important step forward in helping to reduce
        shortages in critical N95 respirators, by allowing for these important
        devices, when decontaminated, to be reused by medical professionals on
        the front lines of the COVID-19 pandemic.


    --  On March 30, 2020, the FDA issued an immediately in effect guidance to
        help expand the availability of surgical apparel for health care
        professionals, including gowns (togas), hoods, and surgeon's and patient
        examination gloves during this public health emergency.


    --  FDA and FTC issued warning letters to two companies for selling
        unapproved products claiming to mitigate, prevent, treat, diagnose or
        cure COVID-19. One of the companies, Corona-cure.com, was warned for
        selling the product Coronavirus Infection Prevention Nasal Spray with
        misleading claims on its website that its product is safe and/or
        effective for the treatment or prevention of COVID-19. The agencies also
        warned Carahealth for selling its herbal products, including "Carahealth
        Immune," with misleading claims of prevention and/or treatment of
        COVID-19. We are particularly concerned that unapproved drugs that claim
        to cure, treat, or prevent serious conditions may cause consumers to
        delay or stop appropriate medical treatment, leading to serious or
        life-threatening harm. There is currently no approved treatment or
        preventative measure for COVID-19. FDA and FTC are closely monitoring
        social media, the online marketplace, and incoming reports for
        fraudulent COVID-19 products on the market.


    --  The FDA issued an updated guidance, "Conduct of Clinical Trials of
        Medical Products during COVID-19 Pandemic," with an appendix adding
        questions and answers on this subject. We plan to update this appendix
        as new questions arise. This guidance is intended for industry,
        investigators and institutional review boards and was issued because we
        recognize that the COVID-19 pandemic may impact the conduct of clinical
        trials of medical products, including drugs, devices and biological
        products.
    --  Diagnostics update to date: During the COVID-19 pandemic, the FDA has
        worked with more than 230 test developers who have said they will be
        submitting emergency use authorizations (EUA) requests to FDA for tests
        that detect the virus. To date, 20 emergency use authorizations have
        been issued for diagnostic tests, including Abbott Diagnostics
        Scarborough, Inc., ID NOW COVID-19, a rapid (13 minutes or less) test.
        Additionally, the FDA has been notified that more than 110 laboratories
        have begun testing under the policies set forth in our COVID-19 Policy
        for Diagnostic Tests for Coronavirus Disease-2019 during the Public
        Health Emergency Guidance. The FDA also continues to keep its COVID-19
        Diagnostics FAQ up to date.

Additional Resources:

    --  Coronavirus Disease 2019 (COVID-19)

Media Contact: Stephanie Caccomo, 301-348-1956
Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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SOURCE U.S. Food and Drug Administration