US FDA Imposed New Market Rules for Antibody Tests to Curb Fraudulent Products

The United States Food and Drug Administration (FDA) announced on Monday, May 4, 2020, that it has reversed the earlier policy for antibody tests in an attempt to curb fraudulent products from marketing and stop incompetent vendors from taking advantage of the policy.

Under the new policy, it would be required for a company to apply for emergency use authorization (EUA) and their applications for coronavirus antibody tests would undergo an agency review.

FDA Aiming to Curb Fraudulent Companies

As per the previous policy, companies were only required to attest that their product was valid and labeled as unapproved which invited several unprofessional companies to involve in antibody tests as the scope of its market was huge. Reuters last week reported, as many as 170 companies applied for the antibody test market including incompetent vendors, which on several occasions, made false claims.

The FDA said in a statement, “Flexibility never meant we would allow fraud. We, unfortunately, see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” explaining loopholes existed in the previous rules of antibody tests.  The federal agency added that it had taken action against firms for unlawfully marketing tests by detaining and refusing illegitimate test kits in the country.

Blood tests for antibodies are mainly conducted to determine who has been previously been infected with the virus and find out the presence of antibodies, which can be possibly immune to the virus infection. A widespread antibody testing was needed since the virus could be spread by people with no symptoms and for lifting lockdown, which would allow many Americans to go back to work.

New Rules for Antibody Tests

Under the new policy introduced by the FDA, companies that wish to involve in antibody testing must submit requests for EUA of their tests within 10 days after the confirmation of the test is valid. Moreover, companies that are currently on the market under the previous policy must submit an application for EUA, and presently, there are about a dozen tests on the market that have already received EUAs.

The FDA explained that it would share information of those companies that were no longer in compliance with its new requirements and remove them from its website by displaying such information to potential buyers such as hospitals. The agency also set certain criteria for the companies’ performance for specificity and sensitivity for all serology test developers to ensure a high level of accuracy.

Over the past two weeks, lawmakers called for the reversal of the lax policy of antibody tests; Democratic Congressmen, Raja Krishnamoorthi, who led a subcommittee investigation, looked into the release of tests that failed to prove successful. Meanwhile, Democratic Congressman Lloyd Doggett of Texas said in a statement on Monday that the FDA’s policy change was not enough to assure consumer protection.

Leave a Reply

Your email address will not be published. Required fields are marked *