tests beginning in late february the agency came under fire for taking too long to allow private companies to get diagnostic tests for the coronavirus onto the market now the fda faces additional scrutiny for permitting manufacturers to distribute the antibody tests too quickly without proof of efficacyevery step this agency has taken in response to covid19 has been a balance of risk and benefits said dr stephen hahn the fda commissioner in a telephone call with reporters on mondayin a statement on monday dr anand shah the fda deputy commissioner for medical and scientific affairs and dr jeffrey shuren director of the center for devices and radiological health defended the agencys initial policy saying the tests were never intended to be used as the sole basis for determining whether anyone had been infectedwe unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of americans anxiety they said in the statement some test developers have falsely claimed their serology tests are fda approved or authorized others have falsely claimed that their tests can diagnose covid19 or that they are for athome testingdr shah and dr shuren also pointed to the nih evaluation that showed a number of tests producing faulty results the fda declined to provide details on the number of tests that were studied or how many did not work they also said that the fda is reviewing more than 200 antibody tests to determine whether they work well enough to get the agencys goaheadscott becker the chief executive of the association of public health laboratories was pleased by the fdas announcement which he said would improve the quality of antibody tests he also said the crackdown comes six weeks too latethe food and drug administration made the right decision by walking back its policy on serology testing for covid19 mr becker said weve long been concerned that allowing tests on the market that have not been approved and authorized for use is a recipe for disasterin addition as states and cities look for ways to reopen businesses dr hahn said on monday whether a test should be a ticket for someone to go back to work as the sole item my opinion on that would be no because there are a lot of unanswered questions