COVID-19 update: FDA Commissioner reflections, Innovations to respond, Testing basics, Hospital beds- stretchers-mattresses, Educational resources, Updated scientific FAQs on testing

The COVID-19 Pandemic — Finding Solutions, Applying Lessons Learned

Reflections from 24th FDA Commissioner Dr. Stephen Hahn

  • Inability to control the events that affect our lives
  • History teaches us that crises often lead to accelerated change and innovations and new discoveries
  • FDA continuously innovating and accelerating measures-for food, drug, devices, diagnostics- to respond to pandemic
  • Learnings will influence FDA functioning post-pandemic

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Innovation to Respond to COVID-19

Connect Manufacturers and Health Care Entities: Facilitating information-sharing regarding the use of 3D printing and other advanced manufacturing technologies in the context of personal protective equipment (PPE) and other medical device parts

 Collaborations to Promote Real-World Data Analysis : Harness diverse streams of data to understand and respond to COVID-19 with the potential to contribute to the scientific evaluation of potential diagnostics and interventions

Coronavirus Treatment Acceleration Program (CTAP) : Special emergency program to accelerate new treatments to patients as quickly as possible, while at the same time finding out safety and effectiveness.

Guidance Documents to Support Innovators and Researchers : To accelerate development of prevention and treatment options, increase efficiency of initiating new trials with recommendations for clinical trial designs


COVID-19 Testing Basics

FDA information on different categories of tests

  • Diagnostic Test: Can show if you have an active coronavirus infection and should take steps to quarantine or isolate yourself from others. Currently there are two types of diagnostic tests – molecular (RT-PCR) tests that detect the virus’s genetic material, and antigen tests that detect specific proteins on the surface of the virus.
  • Antibody test: Looks for antibodies that are made by the immune system in response to a threat, such as a specific virus. Antibodies can help fight infections. Antibodies can take several days or weeks to develop after you have an infection and may stay in your blood for several weeks after recovery. Because of this, antibody tests should not be used to diagnose an active coronavirus infection. At this time researchers do not know if the presence of antibodies means that you are immune to the coronavirus in the future.

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COVID-19: Hospital Beds, Stretchers, and Mattresses

Information to manufacturers of hospital beds, stretchers, and mattresses to meet increased demand

  • How to know of potential shortage in advance or reporting shortages
  • How does FDA regulate hospital beds, stretchers, and mattresses and what are the guidances
  • What are applicable recognized consensus standards
  • Claims of antimicrobial or antiviral properties
  • Requirements regarding new and non-traditional supply chain partners

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COVID-19 Educational Resources

FAQs on Testing for SARS-CoV-2


Image credit: FDA

COVID-19 update: Product terminology, First Standalone at-home sample collection kit , COVID MyStudies App, Guidance to streamline test development, Cancer doctor’s perspective: hydroxychloroquine and chloroquine, Updated EUAs

FDA Terminology of COVID-19 Potential Preventions and Treatments

  • FDA Approved: Independent scientific reviews to determine safety and effectiveness for its intended use and manufactured according to federal quality standards
  • Investigational Treatment:  Experimental- to study use in diease/condition, safety, dose, benefits and risks
  • Expanded Access: Potential pathway for patient with serious/immediately life threatening disease to gain access to investigational product outside of clinical trials
  • Emergency Use Authorization (EUA): Different than approval or clearance; product availability based on the best available evidence, without waiting for all the evidence. Effective until emergency declaration ends
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First Standalone At-Home Sample Collection Kit 

Everlywell COVID-19 Test Home Collection Kit

INDICATION: For use by individuals to self-collect nasal swab specimens at home, when determined by a healthcare provider to be appropriate based on results of a COVID-19 questionnaire, and for use only with in vitro diagnostic (IVD) molecular tests for the detection of
SARS-CoV-2 RNA that are indicated for use with the Everlywell COVID-19 Home Collection Kit

DESCRIPTION:

  • Used by individuals at home screened via online questionnaire & reviewed by health care provider
  • Self-collect a nasal sample at home using Everlywell’s authorized kit (nasal swabs and tube filled with saline to transport the sample back to a specified lab)
  • Samples tested by specific CLIA-certified laboratories each with individual EUAs to test Everlywell at-home sample collection kit (Fulgent Therapeutics, Assurance Scientific Laboratories)
  • Results to patient through Everlywell’s independent physician network and online portal

SUPPORTING DATA:

  • Data from studies supported by The Bill and Melinda Gates Foundation and UnitedHealth Group to demonstrate stability of specimens during shipping
  • Study data freely available to support other EUA requests, alleviating burden of recreating the same study 

EUA


COVID MyStudies App

  • Free platform to remotely obtain informed consent from patients in COVID-19 trials
  • To assist with clinical trials when patients are in or unable to outpatient clinics
  • In Apple App and Google Play

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Guidance on Steps to Streamline Development of Tests

  • Steps to further support development of COVID-19 tests for at-home self-collection
  • Voluntary  EUA Template for at-home sample collection kits
  • Template reflects FDA’s current thinking on data and information that developers should submit to facilitate EUA process
  • Includes recommendations for use by laboratories and commercial manufacturers
  • Applies to EUA as well as part of an Institutional Review Board (IRB)-approved study

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Cancer Doctor’s Perspective: Hydroxychloroquine and Chloroquine

FDA plays pivotal role to provide new medical products to patients as soon as possible, while at the same time determining effectiveness and if benefits outweigh the risks

Drugs hydroxychloroquine and chloroquine have received particular attention

  • Both are FDA-approved to treat or prevent malaria, and hydroxychloroquine is also approved to treat autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis – have a well-established safety profile for these conditions
  • NOT approved to prevent or treat COVID-19 – subject of numerous clinical trials
  • FDA neither endorses individual prescribing decisions nor prohibits physicians from prescribing
  • It is important that patients and health care providers understand side effects including serious and potentially life-threatening heart rhythm problems as noted in a recent Drug Safety Communication
  • FDA issued EUA that allowed for treatment of certain hospitalized COVID-19 patients for whom a clinical trial is not available, or participation is not feasible
  • Will continue to look at the data to make future determinations on these products based on available evidence including ongoing clinical studies

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Updated page on current and terminated Emergency Use Authorizations for COVID-19


Image credit: FDA