Much More Needed from FDA in Replacing its “Anything Goes” Antibody Test Policy
***Press Release***
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FOR IMMEDIATE RELEASE May 4, 2020 | Contact: Kate Stotesbery 202-494-4620 (Cell) |
Much More Needed from FDA in Replacing its "Anything Goes" Antibody Test Policy
Washington, D.C. – Following today's Food and Drug Administration (FDA) announcement of changes in requirements for antibody tests, U.S. Representative Lloyd Doggett (D-TX), Chairman of the House Ways and Means Health Subcommittee, released the following statement:
"The FDA's ‘anything goes' policy for antibody testing has been an invitation for fraud with tests whose results currently offer little value, while misinforming important risk management decisions. Today's alert to health care providers and consumers is the very type of alert that the FDA failed itself to timely recognize. This announcement is mostly excuse-making without detailing sufficient steps being undertaken to assure consumer protection. This is much more than an import problem. The FDA has not outlined what oversight actions it will take to remove fraudulent tests and recoup payments made by abused consumers."
Rep. Doggett has previously urged the FDA to update its antibody test policy as well as provide information on its oversight actions and the accuracy of both diagnostic and antibody tests. The FDA has not responded to either inquiry. You can read his previous inquiries regarding antibody tests here, and his inquiry regarding diagnostic tests here.
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