Democrat lawmakers call for more regulation around antibody tests
UPDATED 12:02 PM PT — Saturday, April 25, 2020
House lawmakers recently slammed the FDA, saying the administration has allowed coronavirus antibody tests to enter the market without approval. In a letter to Democrat members of the Subcommittee on Economic and Consumer Policy, they claimed the FDA is not reviewing accuracy or regulating these products before they enter the market.
However, officials have said they’ve done so to make it “easier” to disseminate tests. They emphasized they’ve taken proper steps to make sure protections are in place and consumers know what they’re signing up for.
“Under our policy, we provide flexibility. We’ve told manufacturers that in order to market in the U.S., they have to validate their tests. They have to tell us that they validated their tests and then, in the package insert, they have to let people know…that those tests were not authorized by FDA.” – Dr. Stephen Hahn, Chief Administrator of the FDA
According to Democrats, more than 100 tests are on the market without approval, which they claimed poses a dangerous risk to Americans.
Meanwhile, two new studies have suggested many more people may have coronavirus, but might not be experiencing symptoms. In a study released Friday, researchers in Washington tested an entire nursing home. They found half of the people in the home tested positive and had not experience symptoms.
After a random sampling of nearly 2,000 residents in Miami-Dade County, Florida, officials estimated approximately 165,000 people in the county may have had the virus.
The results may help explain continued infection rates, as people who have the virus unknowingly may go out and infect others.