https://www.politico.com/news/2020/09/1 ... les-415400HHS chief overrode FDA officials to ease testing rules
Alex Azar took matters into his own hands, overriding objections from FDA chief Stephen Hahn.
Pressed on the matter during a private briefing of the House Energy and Commerce Committee on Aug. 31, Hahn told lawmakers that HHS’ legal division was responsible for the decision, a source familiar with his comments said.
The FDA’s own website, meanwhile, still insists that it has the power to regulate all manner of lab-developed coronavirus tests. “Please note that LDTs should not be used for clinical diagnoses without FDA’s approval, clearance or authorization during an emergency declaration for that disease,” the site reads.
For its part, HHS has offered limited public health rationale for sidelining the FDA at a pivotal moment in the response, as test production ramps up and the U.S. heads into a fall season that could bring a resurgence of both the coronavirus and the seasonal flu.
Supporters of the decision contend that the more lax approach could help speed newer, more innovative tests onto the market by allowing manufacturers to bypass the potentially cumbersome FDA review process.
And inside the administration, top HHS officials led by General Counsel Bob Charrow argued for months that the FDA lacked the legal authority required to regulate this particular slice of the testing market, which includes labs located in larger academic medical centers and smaller commercial laboratories, as well as a handful of large corporations.
That echoes a position long held by some clinical laboratories subject to the agency's regulation. Yet it encountered fierce resistance from FDA attorneys who maintained that the agency had long established its jurisdiction over lab-developed tests during prior public health emergencies like the H1N1 pandemic and Zika outbreak.
As the internal dispute mushroomed, some White House lawyers also expressed skepticism of the immediate need to pare back the FDA’s oversight activities, two people with knowledge of the situation said.
Azar nevertheless pressed ahead, a decision several officials said had soured relations with top FDA officials and career staff while accomplishing little measurable progress in the fight to contain the pandemic.
Indeed, the nation faced major testing access issues in February and March in part because there was no clear FDA pathway for emergency use of lab tests, said former FDA Commissioner Mark McClellan, who has advised HHS on testing strategy.
But "since then, I think they have kind of got it right, or at least made real progress," he said.
"There's no issue with LDTs or frankly any test getting quickly through the FDA right now," a Republican close to the administration added. Going to war with its own agency in the middle of a crisis, on the other hand, ranks "right up there with the dumbest things ever."
We have idiots running the train rather than the trained engineers. So we are going off the tracks and more people will die. Trump Lie - People die