The COVID-19 pandemic has caused dramatic interruptions across all industries, but clinical trial and drug development professionals are keen on continuing their work. Over the past week, the US Food and Drug Administration (FDA) has issued a number of guidance documents, rulings, blogs and other information designed to inform and advise such professionals in the face of the global health crisis.
The agency has revoked the emergency use authorization (EUA) that allowed for chloroquine phosphate and hydroxychloroquine sulfate that had been donated to the Strategic National Stockpile to be used to treat certain hospitalized patients with COVID-19. The EUA no longer applies in situations when clinical trial is unavailable, or participation in a clinical trial is not feasible.
FDA officials determined the legal criteria for issuing an EUA are no longer met. Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA.
Additionally, based on numerous reports of serious cardiac adverse events and other potential serious side effects, the agency believes the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.
Clinical trial considerations
The agency released its guidance document “Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency Guidance for Industry.” The brief document is intended to offer guidance to researchers working on treatments for the virus as well as other diseases and conditions.
Because clinical research and drug development across investigational product areas have been impacted by public health measures to control the COVID-19 virus, the document shares recommendations on statistical considerations to address the impact of COVID-19 on meeting objectives of clinical trials conducted during the pandemic.
COVID-19 test EUA
The FDA issued an EUA for a COVID-19 test produced by Cue Health. The test is approved for point-of-care useoperating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
“Point-of-care: refers to results given to patients in hospitals, urgent care centers, and emergency rooms, instead of samples being sent to a laboratory. The intent of this approach is to provide more immediate access to test results.
Rare disease priority
The agency released an FDA Voices document titled Rare Disease Therapy Development and Access Remain Top FDA Priorities During COVID-19. The document explains the FDA’s ongoing work to advance treatments for rare diseases, and efforts designed to ensure continuity of care for patients with those diseases during the COVID-19 public health emergency.
In the document, Patrizia Cavazzoni (acting director of the Center for Drug Evaluation and Research) and Peter Marks (director of Center for Biologics Evaluation and Research) acknowledge the myriad challenges the pandemic have placed upon clinical trials and development, such as site closures and travel restrictions. However, they express a desire among agency officials for pursuit of treatments for rare diseases to continue in the face of these obstacles.
The agency continues to slap the wrist of companies promoting and selling products that they claim can prevent, treat or cure COVID-19, in the form of warning letters. To date, there are no FDA-approved preventives or treatments on the market.
- OutOfTheBoxRemedies.com was cited for selling iodine-based products for COVID-19 treatment.
- EUCYT Laboratories received a warning letter for marketing an unapproved exosome product for the treatment or prevention of the virus.
- A number of companies, including one named “My Covid19 Club,” were cited for selling unauthorized COVID-19 antibody tests directly to consumers.