Taking a multi-pronged approach, the FDA’s efforts include educating legitimate test manufacturers and labs while “actively and aggressively monitoring” for fakes on the market.
Town hall series
The Agency will be holding a virtual Town Hall Series beginning Wednesday, Mar. 25 at 3pm Eastern time on its effective-immediately guidance, Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. These town halls are intended for clinical labs and commercial manufacturers—who are either developing or have developed diagnostic tests for SAR-CoV-2—to get their questions answered.
For more information and call-in information, scroll below or visit the FDA meeting page.
Five additional dates have been announced throughout April.
Coronavirus COVID-19 diagnostic tests hotline
For test developers and labs who have questions about the EUA process or spot shortages of testing supplies.
Contact the toll-free line 24 hours a day: 1-888-INFO-FDA, choose option *
Fighting fraud
Meanwhile, there are already fraudulent tests showing up on the market for at-home use. The Los Angeles Daily News reported that U.S. Customs and Border Protection officers seized counterfeit COVID-19 test kits at the LAX International Mail Facility.
FDA is continuing to monitor for firms making product claims, including unauthorized COVID-19 diagnostics, prevention and treatment claims.
“We want to alert the American public that, at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19. The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers in this space,” said a release from Commissioner Stephen Hahn M.D. and Associate Commissioner for Regulatory Affairs Judith A. McMeekin Pharm.D.
As Systech’s Steve Tallant points out, this situation is ripe for counterfeiting—almost unprecedented demand coupled with an unprecedented lack of supply. It’s dangerous on multiple levels. Tallant says, “The fake test producing a false positive result on a healthy person contributes to overburdening national healthcare systems. The fake producing a negative result on an infected patient contributes to further spread of the virus, and possible death for the person coming from a delay in treatment.”
In the race to rapidly produce and distribute test kits, treatment and vaccines, brand protection should not be overlooked. Seasoned pharmaceutical and device companies may be used to this, but not all start-ups are well-versed in supply chain security features. With the world looking to manufacturers to deliver solutions, the pressure is certainly on. The need for attention to detail is critical.
FDA's virtual town halls (no registration required)
- March 25, 2020 from 3:00 pm – 4:00 pm Eastern Time
- April 1, 2020 from 3:00 pm – 4:00 pm Eastern Time
- April 8, 2020 from 3:00 pm – 4:00 pm Eastern Time
- April 15, 2020 from 3:00 pm – 4:00 pm Eastern Time
- April 22, 2020 from 3:00 pm – 4:00 pm Eastern Time
- April 29, 2020 from 3:00 pm – 4:00 pm Eastern Time
U.S. Callers dial:
- 888-455-0199
- Conference Number: RWXW1056963
- Passcode: 6832800
