ALBANY, N.Y. – U.S. Sen. Charles Schumer says there are now several unregulated, at-home coronavirus test kids available online, and he is calling on the federal Food and Drug Administration (FDA) to better monitor and inspect these products.
“While the coronavirus itself continues to risk infecting people, varying at-home test kits for the virus’s antibodies, and even the disease itself, are now infecting the internet and the consumer marketplace. However, the vast, vast majority of these ‘kits’ are unproven, untested and totally unregulated by the FDA, and that’s dangerous,” said Schumer. “That is why I am publicly calling on the FDA to institute a crackdown on these kits now exploding across the internet. The agency (FDA) must raise the bar, move heaven and earth and stand up for consumers who are vulnerable, uncertain and anxious with all that is going on.”
While faulty tests that can be purchases online are a risk to public safety across the country, Schumer says New York residents are some of the most vulnerable.
“The authenticity and accuracy of any at-home testing kits must be paramount at the FDA, because consumers are not only willing to buy them, but they are willing to rely upon them. Shoddy tests could spell disaster for hot spot states like New York because if there is anything New York and other places will require to turn the page on this virus, it’s rooted in testing accuracy, and these unregulated kits pose serious risk to the overall recovery,” he said.
Schumer wrote the following letter to FDA Commissioner Stephen Hahn to address his concerns:
Dear Commissioner Hahn:
The array of misinformation about the coronavirus is a danger to public health and an impediment to a swift and full re-opening of our country. One of the most dangerous elements of this misinformation is the volume of unapproved COVID-19 tests available online, many of them claiming they are able to conduct an authentic test at home. As you very well know, these tests are not currently approved. I have grave concerns that New Yorkers, understandably frustrated and desperate because of the broad testing shortage across the country, are turning to these unapproved tests. If such a test is unreliable or administered incorrectly, and a person falsely believes they do not have COVID-19 or have antibodies, that presents a danger to their family and their community.
I appreciate the work that FDA has done thus far, including in its March 20 announcement, in pushing back against these unauthorized tests. However, more must be done. A simple online search, as well as anecdotal evidence from people in New York City, shows that these tests are still easily available and people are buying them. Given how high the stakes are right now, the administration must use all its resources and authority to immediately get these tests off the market.
I request answers to the following questions:
- What is the FDA doing since its March 20 announcement to continue to crackdown on these tests?
- Does FDA have sufficient resources to monitor and respond to the availability of these unauthorized tests?
- What is FDA doing, in coordination with the White House and its press efforts, to educate the public that authorized tests should not be used?
U.S. Senator Charles Schumer