BIG PHARMA POLITICS: Consumers pressure politicians to do something about rising drug prices. Read More
When the U.S. Food and Drug Administration created a policy for coronavirus antibody tests, some vendors took advantage and made false claims to cheat the system.
Blood tests for antibodies can determine who has been previously infected with the virus, which is seen as a key piece in the effort for Americans to return to work safely.
Reuters reports that the new policy requires test-makers to submit requests for emergency use authorization to the FDA within 10 days of when the test is validated. Companies that already have tests on the market based on the previous policy must now submit this emergency authorization application.
The new process also sets requirements for sample tests. Approved kits must have a minimum level of correct positive results at 90 percent of the samples tested, and a minimum for tests showing negative results correctly at 95 percent.
Despite the policy change, Rep. Lloyd Doggett (D-TX) said the FDA has not gone far enough to protect consumers and that fraudulent tests must be removed from the market. Meanwhile, former FDA head Scott Gottlieb said COVID-19 antibody tests are not accurate enough for individuals to rely on to make decisions that affect their health.
Have you bought a COVID-19 antibody test? Share your experience with Voices for Affordable Health.