Azar Overruled Hahn on Covid Test Jurisdiction: Politico
After failing to convince FDA commissioner Stephen Hahn that the agency should give up its responsibility for evaluating the safety and accuracy of laboratory-developed Covid-19 tests, HHS secretary Alex Azar took the matter into his own hands and revoked FDA’s ability to evaluate the tests. In an exclusive report based on interviews with seven current and former administration officials familiar with the dispute, Politico says the controversial change had long been sought by the commercial, university, and public health labs in the name of greater flexibility. It says Hahn viewed the move as inappropriate and ill-timed because it removed safeguards designed to prevent inaccurate tests from flooding the market during a public health crisis.
The report says that nearly a dozen current and former Trump administration officials and others with knowledge of the matter told Politico that the fight has driven a wedge between FDA and HHS. “At some points, the dispute was so intense that it boiled over into screaming matches between Azar and Hahn,” the report says, based on talks with four sources. And CDRH director Jeffrey Shuren was left out of some of the key discussions. (HHS chief of staff Brian Harrison denied the screaming matches ever occurred, saying that all discussions between Azar and Hahn were very professional.)
“I’ve never seen such a complete political overruling of the agency,” a former HHS official told Politico. “It makes me worried about what’s to come.”
Harrison told Politico Azar’s decision was based on a legal review that determined that FDA had no legal authority to be evaluating the tests. “Primarily, it was our lawyers advising us that this requirement was illegal,” he said in a statement. “Additionally, everyone would agree that at the beginning of a pandemic we need to maximize the development of quality diagnostics as fast as possible.”
However, the report says, Hahn and other FDAers didn’t agree with the need for the change. They reportedly saw it as a bewildering power grab made even more objectionable by its timing, coming in the midst of a pandemic that has put a premium on accurate Covid-19 testing.
The story notes that after FDA loosened its rules for tests early in the pandemic so labs could delay seeking emergency use authorization, widespread flaws were discovered. Some 82 of 125 tests eventually submitted to the agency for authorization had “design or validation problems,” as reported by Shuren and CDRH Office of In Vitro Diagnostics and Radiological Health director Tim Stenzel in the New England Journal of Medicine.
Politico says FDA experienced a similar problem when it decided several months ago to let antibody tests be marketed without agency review. That decision was reversed weeks later and scores of faulty or inaccurate tests were recalled.
Harrison said that when HHS learned of the regulatory hurdle to laboratory-developed tests it sought a legal review. “This deregulatory action will better prepare us for future pandemics,” he said. He also said HHS maintains it did not overrule FDA “because FDA has no jurisdiction of matters of law.”