Weekly FDA COVID-19 updates and actions
While federal and state leaders wrangle with reopening of businesses, surges in new cases, resistance to mask-wearing and other issues, the US Food and Drug Administration (FDA) continues to offer advice and resources to pharmaceutical and life-sciences companies working on solutions during the pandemic.
FDA COVID-19 actions to date
The agency has updated its long list of actions taken and advice issued during the pandemic in reaction to the virus. The list includes information impacting the pharmaceutical industry, food manufacturers and distributors, and other professionals.
The highlights from the list include:
- Report of nearly 150 active therapeutic agents for COVID-19, with another 457 development programs for therapeutic agents in the planning stages
- Total of 161 emergency use authorizations (EUAs) issued for testing
- Partnerships designed to share information and accelerate development and discovery of therapies, such as the CURE Drug Repurposing Collaboratory, a forum for exchanging clinical practice data to uncover alternative uses for existing drugs
- Update on how the European Medicines Agency and other bodies around the world are leveraging each other’s expertise to come up with responses to the global health crisis
- Pulling nearly 200 unapproved, uncleared or unauthorized products claiming to diagnose, treat, prevent or cure COVID-19
EUA for flu/COVID-19 combo tests
The FDA issued an emergency use authorization (EUA) for a third test that detects and differentiates the viruses behind influenza and COVID-19. The agency previously had issued EUAs to BioFire Diagnostics and Qiagen GmbH for their tests, which also detect a number of other respiratory organisms.
FDA commissioner Stephen Hahn said the combination tests are geared toward addressing the concerns of the public during the pandemic, and the onset of the next flu season.
“With just one swab or sample, combination tests can be used to get answers to Americans faster. This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment,” Hahn said.
The tests take one sample from a patient to test for multiple conditions, including the flu and COVID-19. Potential advantages include patient convenience due to the ability to test once for multiple conditions, and reduced consumption of supplies and materials (including swabs, personal protective equipment and reagents).
Clinical trial guidance for device research
The agency added content to its guidance Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. The updated guidance clarifies information on two previously suggested methods for obtaining informed consent from a hospitalized patient in isolation.
Additionally, the document includes an updated Q&A section on how to obtain informed consent from a prospective trial participant in certain circumstances where the enrollment timeframe is limited and the patient can receive a copy of an informed consent document electronically but cannot sign it electronically or print it out for signature. The guidance also clarifies recommendations on documenting details when using video conferencing for trial visits.
Unscrupulous COVID-19 ‘treatment’ manufacturers
As mentioned above, the agency has come down on numerous companies offering products direct to consumers that purportedly detect, treat, prevent or cure the virus—notable, because the agency has to date authorized the distribution of zero products for that purpose.
The latest scofflaw suppliers added to the list include:
- SinoTradition.com, selling Lianhua Qingwen Capsules and other items purported to treat the virus
- Butterfly Expressions, a company offering “blessed waters,” essential oils, hand sanitizers, homeopathic products, and tinctures for sale
- Lotus Herbal Supplements, Lianhuaqingwencaps.com, and Shen Clinic; each of these three companies was cited for selling traditional Chinese medicines purported to treat or prevent the virus
