This week’s FDA COVID-19 updates
The US Food and Drug Administration (FDA) has provided informational resources, offered guidance and taken action in the face of the COVID-19 pandemic. These moves are intended to help pharmaceutical manufacturers, clinical researchers and other stakeholders deal with both COVID-19-related work and other operations.
Trial advice update
The agency has updated the question-and-answer appendix to its guidance document “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” First issued in March, the document is intended to answer key questions and concerns for research professionals arising during the pandemic.
Updated content in the guidance includes information on reporting serious adverse events among patients with COVID-19. The advice impacts clinical trials focused on developing therapies for non-COVID-19 conditions.
Real-world data
The FDA announced a partnership with healthcare technology firm Aetion to tap into “diverse streams of data to understand and respond to the virus. According to the agency, the aim of the collaboration is to uncover answers to questions about the use of diagnostics and medications in the pandemic, and risk factors for COVID-19-related complications in different patient populations.
Agency representatives reported that the FDA believes data sources such as electronic health records, insurance claims, patient registries and lab results have potential to inform the national response to the COVID-19 pandemic. Its efforts include participation in the COVID-19 Evidence Accelerator, another collaborative project organized by the Reagan-Udall foundation to aggregate and examine relevant data.
Questionable test performance
The FDA expressed concerns the Abbot ID NOW point-of-care COVID-19 diagnostic test. Specifically, the agency said, the test may return false negative results.
“We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue," said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “This test can still be used and can correctly identify many positive cases in minutes; negative results may need to be confirmed with a high-sensitivity authorized molecular test.”
Shady products
While to date the FDA has not approved any products for the prevention or treatment of COVID-19, that has not stopped a number of unscrupulous manufacturers from producing and promiting products that make such claims. The latest products to draw stern warning letters from the agency include:
- Benjamin McEvoy, an Amazon Associate firm offering dietary supplements and other items
- White Eagle Native Herbs, selling herbal cures
- N-Ergetics, selling colloidal silver products purported to cure COVID-19 and other ailments
- Noetic Nutraceuticals, selling CBD products said to block and treat the virus
- Golden Road Kratom, distributing kratom-based items to prevent and treat COVID-19.
