FDA

Press release:

Citing an all-out explosion of unproven, untested and unregulated do-it-yourself, at-home coronavirus test kits now for sale across the internet, U.S. Senator Charles Schumer demanded, today, that the federal Food and Drug Administration (FDA) begin a crackdown focused on more oversight of the marketplace, ramped-up inspections and cease and desist actions against bad actors.

Schumer said a simple “Google” search on these kits now results in a bombardment of antibody and other coronavirus tests that are simply not validated for accuracy by the FDA.

“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," Senator Schumer said. "However, the vast, vast majority of these ‘kits’ are unproven, untested and totally unregulated by the FDA, and that’s dangerous.

"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.”

Schumer said that as part of returning to normal, consumers — especially New Yorkers — could be hard hit by faulty tests that mislead an already uncertain public.

He said that the FDA must immediately move heaven and earth to ensure this emerging testing marketplace does not become riddled with shoddy at-home kits that are not backed by the FDA and the best available science. Schumer also said New Yorkers are currently purchasing these kits and that the feds must act swiftly or risk turning a pandemic into a false sense of security epidemic that hurts hot spots like New York which must rely upon testing accuracy to fully return to normal.

“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," Schumer added. "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."

According to CNN, the “FDA has granted emergency use authorization to only four antibody tests, and there are dozens more awaiting the same authorization. The FDA has also opened a separate process for more than 100 other non-FDA approved tests to be checked for accuracy.”

Schumer says, despite this, at-home coronavirus antibody and virus test kits are for sale across the internet, seemingly unchecked.

Experts across the government have said antibody tests will likely play an important role in the reopening of the economy and the next chapter of public health. Schumer says the FDA cannot offer any regulatory flexibility to some test makers and rigidity for others.

He said the only way to ensure test kit standards are rooted in science and accuracy is to ramp up oversight, inspections and cease and desist actions before unproven products risk turning a pandemic into a false sense of security epidemic that hurts hot spots like New York dependent on accuracy.

“Right now, only formally approved tests should be available for sale to consumers,” Schumer said. “The stakes are too high to let bad actors prey on vulnerable New Yorkers and add even more anxiety and uncertainty to this crisis.”

Schumer’s letter to FDA Commissioner Stephen Hahn appears below:

Dear Commissioner Hahn:

The array of misinformation about the coronavirus is a danger to public health and an impediment to a swift and full reopening 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:

1.     What is the FDA doing since its March 20 announcement to continue to crackdown on these tests?

2.     Does FDA have sufficient resources to monitor and respond to the availability of these unauthorized tests?

3.     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?

Sincerely,

U.S. Senator Charles Schumer

From Senator Charles E. Schumer:

As coronavirus (COVID-19) continues to spread throughout the country, making New York its epicenter with over 10,000 deaths, U.S. Senate Minority Leader Charles E. Schumer today urged the Food and Drug Administration (FDA) to immediately clarify its plan to address the lack over oversight and inspection of the American food supply system – to restore peace of mind to millions.

Last month, the FDA announced the temporary suspension of domestic routine surveillance facility inspections and the relaxation of compliance requirements for food producers.

According to Schumer, as the virus continues to spread throughout the United States, the nation’s grocery and food industries were not spared. Schumer’s concerns over the FDA’s rollbacks were exacerbated by recent reports  of outbreaks in food distribution facilities, processing plants, warehouses, and grocery stores around the nation.

“The COVID-19 pandemic is reaching alarming new levels every day, leaving no part of life untouched and millions of Americans perpetually concerned,” Senator Schumer said. “In the midst of all that we are facing, New Yorkers deserve to have the peace of mind that the food on their tables is safe to eat.

"Contaminated food sickens and kills thousands of Americans every year and the challenge of this virus must not be an excuse to let our guard down when it comes to keeping our food supply safe for consumers. The FDA must not scale back essential food-safety inspections and must maintain food-production requirements and guarantee the safety of our food supply in these trying times."

Schumer’s call for adequate oversight and inspection of the domestic food supply follows reports that the FDA has suspended routine surveillance facility inspections and relaxed compliance requirements. The senator demanded to know how the FDA was guaranteeing food safety for Americans, especially during a time where New Yorkers are depending on a reliable food supply.

The Center for Diseases Control estimates that roughly one in six Americans, or 48 million people, get sick, 128,000 are hospitalized, and 3,000 die of foodborne illnesses every year, even with the FDA’s usual regulations in place.

Salmonella alone causes about 1.2 million illnesses and 450 deaths in the United States, costing about $350 million annually. A salmonella outbreak linked to papaya sickened 24 people in New York last year.