“The Food and Drug Administration is a key federal health agency in the country’s response to the COVID-19 public health crisis, but with limited data on the virus, the agency is adapting and learning lessons as it goes.”
“The agency has recently approved rapid-diagnostics tests, possible drug treatments such as hydroxychloroquine and remdesmivir, and 3D-printed face masks with unprecedented speed. But it remains vital for the agency to continue making well-informed decisions to ensure the safety and efficacy of these treatments and products.”
“’We need to simultaneously balance the need to move fast and make sure that clinicians, drug developers [and] vaccine developers have the tools that they need, while also making sure that we maintain the standards we expect,’ said FDA Principal Deputy Director and Acting CIO Amy Abernethy during the virtual 2020 World Medical Innovation Forum Monday. ‘The task is to make sure that we move as quickly as possible, but do so in a judicious way that’s constantly being ‘right-sized.’’”
“One example of ‘right-sizing’ is with the approval and monitoring of diagnostics tests. The FDA released an emergency-use authorization March 16 for the development of diagnostics so that more could be available to the market, said Abernethy. In the context of serology (antibody) tests, the agency realized the tests did not have the sensitivity and specific data required to assess and diagnose patients. The agency then issued an amended authorization May 5 so that companies with serology tests for COVID-19 would have to send information about test sensitivity and specificity before gaining market approval…”
“The rapid approval of COVID-19 treatments like hydroxychloroquine marks another example in which the agency has had to make timely adjustments given limited, yet potentially promising, data on treatment efficacy…” Read the full article here.
Source: FDA Addresses Data’s Critical Role in COVID-19 Response – By Faith Ryan, May 15, 2020. GovernmentCIO.
