The US Food and Drug Administration (FDA) continues to be a source of information and advice for professionals in the life-sciences industry. The most recent activities coming from the agency include authorizations for tests, warnings of sketchy consumer products, and a controversial potential treatment.
The agency has caused a stir by throwing its tentative support behind use of convalescent plasma as a COVID-19 treatment. As reported in BioPharma-Reporter.com, earlier this week, commissioner Stephen Hahn FDA announced the agency was granting an emergency use authorization (EUA) for use of convalescent plasma in treating COVID-19 patients.
“I am committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible in order to save live,” Hahn said. “We’re encouraged by the early promising data that we’ve seen about convalescent plasma. The data from studies conducted this year shows that plasma from patients who’ve recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus.”
Immediately the announcement was met with skepticism from certain corners of the pharma and medical communities. Walid Gellad, a scientist heading the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, told the New York Times he questions the research and data associated shared by Hahn and other agency sources.
“For the first time ever, I feel like official people in communications and people at the FDA grossly misrepresented data about a therapy,” said Gellad. “That’s a problem if they’re starting to exaggerate data.”
Hahn later apologized for misrepresenting findings around the benefits of convalescent therapy in COVID-19 treatment. "What I should have said better is that the data show a relative risk reduction not an absolute risk reduction,” he said in a statement."
The agency issued its third EUA for a COVID-19 antigen test. The authorization was issued for LumiraDX UK’s LumiraDx SARS-CoV-2 Ag Test, for use in high and moderate complexity laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA), as well as at the point-of-care (i.e., patient care settings) operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
To date, the FDA has currently authorized 221 tests under EUAs. This figure includes include 179 molecular tests, 39 antibody tests, and 3 antigen tests.
Shady COVID-19 products
The FDA continues to monitor and warn companies making and selling products claimed to diagnose prevent, treat or cure the virus. To date, the agency has approved exactly zero consumer products for such use.
Companies and products receiving stern warnings from the FDA recently include:
- SilveryGuy, an Amazon Associates participant, has been offering Colloidal Silver products on its website
- Living Senior LLC has been selling cannabidiol (CBD) products purported to treat COVID-19
- Predictive Biotech has been marketing CoreCyte, an umbilical cord-derived product, to treat the virus; PA Green Wellness received a separate warning for selling CoreCyte