Fraudulent COVID-19 Products

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Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments

Americans sheltering at home to help “flatten the curve”  might be tempted to buy/use fraudulent products to help diagnose, treat, cure, and even prevent COVID-19

  • Vaccine and drug manufacturers  are working to develop new vaccines and treatments as quickly as possible
  • However, some companies are attempting to profit from pandemic by selling unproven and illegally marketed products that make false claims, such as being effective against the coronavirus

There Are No Vaccines or Medicines for COVID-19, Yet

Protect Yourself and Your Family From Coronavirus Fraud

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Image credit: FDA

COVID-19 FDA Guidances

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COVID-19-Related FDA Guidance Documents

  • Providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid response efforts
  • Anticipates to immediately implement  guidances
  • Will consider comments received and update as appropriate

Current List includes:

  • Manufacture of Alcohol for Alcohol-Based Hand Sanitizer Products
  • REMS Requirements
  • Ventilators and Accessories and Other Respiratory Devices
  • Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring
  •  Preparation of Certain Alcohol-Based Hand Sanitizer Products
  • Postmarketing Adverse Event Reporting
  • Conduct of Clinical Trials of Medical Products
  • Food Supplier Verification Onsite Audit Requirements
  • Diagnostic Tests
  • Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products

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COVID-19 Emergency Use Authorizations, Diagnostic Testing policy, N95 Respirators and Surgical Masks

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COVID-19 Emergency Use Authorizations (EUA) for Medical Devices and Diagnostics

EUA being granted as there is significant potential for public health emergency that can affect national security or the health and security 

  1. Personal Protective equipment
  2. Diagnostic tests

Personal Protective Equipment

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  • Disposable filtering facepiece respirators (FFRs) approved by the National Institute for Occupational Safety and Health (NIOSH)
  • FFRs that were NIOSH-approved but have since passed the manufacturers’ recommended shelf-life, for use in healthcare settings by healthcare personnel (HCP) to prevent wearer exposure to pathogenic biological airborne particulates

Diagnostic Tests

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  • Qualitative Real-Time RT-PCR test for qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens from individuals suspected of COVID-19 by their healthcare provider
  • Positive test result  indicates RNA detected, patient is infected and presumed to be contagious; patient management should follow current CDC guidelines
  • Negative test result means RNA was not present in specimen; does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions

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Policy for Diagnostic Tests for COVID-19 during the Public Health Emergency 

Two policies for accelerating the development of certain laboratory tests for COVID-19

  1. EUA submission to FDA
  2. No EUA submission
    • When test is developed under State authorities and State takes responsibility for testing by laboratories
    • CLIA certified and meet requirements

Laboratories offering testing under Policy

  • AdventHealth
  • ARUP Laboratories
  • Assurance Scientific
  • Baylor Scott and White Medical Center – Temple
  • BioReference Laboratories
  • The Children’s Hospital of Philadelphia
  • Diatherix Eurofins
  • Emory Medical Laboratory, Emory Healthcare
  • Gravity Diagnostics
  • Henry Ford Health System
  • HMH Hackensack University Medical Center
  • Hospital of the University of Pennsylvania
  • Houston Methodist Hospital
  • Integrity Laboratories
  • Johns Hopkins Medical Microbiology Laboratory at Johns Hopkins Hospital
  • Montefiore Medical Center
  • New York Presbyterian Hospital -Weill Cornell Medicine (NYPH-WCM)
  • Next Bio-Research Services LLC
  • NYU Langone Medical Center
  • Quest Diagnostics Infectious Disease, Inc.
  • Stanford Health Care Clinical Laboratory
  • Texas Children’s Hospital Department of Pathology
  • TGen North, Clinical Laboratory
  • UCSF-Health
  • University of Washington
  • Viracor Eurofins Clinical Diagnostics

Other FAQs


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N95 Respirators and Surgical Masks (Face Masks)

FDA regulates surgical masks and surgical N95 respirators differently based on their intended use

  • Surgical mask : Loose-fitting, disposable device that creates physical barrier between mouth and nose of wearer and potential contaminants in the immediate environment. Edges of mask are not designed to form seal around nose and mouth
  • N95 respirator: Respiratory protective device designed to achieve very close facial fit and very efficient filtration of airborne particles; edges designed to form seal around the nose and mouth.

N95 Respirators not for public use 

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Image credit: FDA, CDC

Increased availability of NIOSH approved respirators to healthcare personnel

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FDA and CDC take action to increase access to respirators, including N95s, for health care personnel

FDA-CDC collaboration to prioritize access to needed medical products through Emergency Use Authorization (EUA) 

  • Certain industrial respirators during the COVID-19 outbreak in health care settings
  • Respirators approved by NIOSH, but not currently meeting the FDA’s requirements, that may be effective in preventing health care personnel from airborne COVID-19 exposure

EUA does NOT apply to the general American public

  • Should not wear these respirators to protect against COVID-19
  • No added health benefit

FDA information

CDC information


Image credit: FDA

COVID-19 News: New expedited diagnostic testing policy, New York SARS-CoV-2 diagnostic authorization, Medical product shortages, Misinformation about natural products

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Policy for COVID-19 Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization 

Policy for novel COVID-19 molecular diagnostics tests developed and used in CLIA laboratories prior to FDA issuance of emergency use authorizations (EUA) 

  • Public health emergency circumstances requiring rapid diagnostic testing to control emergence
  • Rapid COVID-19 detection with accelerated policy enabling CLIA laboratories for more rapid testing capacity
  • Immediately in Effect guidance
  • Accelerated Emergency Use Authorization Template

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New York SARS-CoV-2 Realtime Reverse Transcriptase (RT)-PCR Diagnostic Panel 

Wadsworth Center, New York State Department of Public Health 

INDICATION: Presumptive qualitative detection of nucleic acid from SARS-CoV-2 in  nasopharyngeal/oropharyngeal swabs and sputa collected from individuals who meet CDC COVID-19 clinical and/or epidemiological criteria

DIAGNOSTIC PANEL:

  • Human Specimen Control (HSC): A human cell culture preparation used as an extraction control and positive control for the RNase P primer and probe set that is extracted and tested concurrently with each specimen extraction run
  • SARS-CoV-2 Positive Control (SARS-CoV-2 Pos): Run with each batch of specimens. Monitors improper assay setup, reagent failures of rRT-PCR reagents and reaction conditions
  • No Template Control (NTC): Nuclease-free water included in each run. Monitors for reagent and system contamination
  • RNase P (RP) control in clinical samples: The RP primer and probe set is included in each run to test for human RNase P, which controls for specimen quality and demonstrates that nucleic acid was generated by the extraction process

REGULATORY PATHWAY: Emergency Use Authorization

  • SARS-CoV-2 can cause a serious or life-threatening disease or condition
  • Based on the totality of scientific evidence, reasonable to believe diagnostic panel may be effective in diagnosing COVID-19
  • There is no adequate, approved, and available alternative

Letter of Authorization

Fact Sheet


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COVID-19 Supply Chain Update

Outbreak would likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S

  • Alert from a manufacturer about drug shortage due to disruption in China manufacturing
  • In contact with >180 manufacturers of human drugs
  • In contact with 63 manufacturers of essential medical devices
  • Preparing for increasing demand in personal protective equipment—surgical gowns, gloves, masks, respirator protective devices etc
  • Not aware of any cellular or gene therapies that are made in China
  •  No reports of transmission by food or food packaging

Proposals  to prevent or mitigate medical product shortages

  • Lengthen expiration dates
  • Require risk management plans
  • Improve data sharing and require more accurate supply chain information
  • Establish reporting requirements for device manufacturers

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Image credits: FDA, NIH