By Kevin Stawicki

Law360 (May 14, 2020, 4:13 PM EDT) -- The former U.S. Department of Health and Human Services vaccine chief allegedly ousted for resisting President Donald Trump's calls to promote a malaria drug for COVID-19 warned Thursday that the "window is closing" to create a strong government strategy to fight the pandemic.

Rick Bright, the ex-director of HHS' Biomedical Advanced Research and Development Authority, told the House Energy and Commerce Committee's health panel that the government failed to start vaccine development early enough and forced him out for challenging the use of chloroquine and hydroxychloroquine as COVID-19 treatments.

"Our nation was not as prepared as we should have been, as we could have been," Bright said Thursday. "Some scientists raised early warning signals that were overlooked, and pages from our pandemic playbook were ignored by some in leadership."

"The window is closing to address this pandemic because we still do not have a standard, centralized, coordinated plan to take our nation through this response," Bright said.

Bright's removal on April 20 came on the same day that a national study was released suggesting that hydroxychloroquine treatment at veterans hospitals didn't help treat COVID-19 and in fact was associated with more deaths than standard care. Three days later, the U.S. Food and Drug Administration issued a warning that those drugs reportedly had serious and life-threatening side effects when used to treat the virus.

When a coronavirus vaccine becomes available, Bright said its distribution will likely face challenges similar to those seen with the experimental COVID-19 drug remdesivir. The antiviral drug, which is sold by Gilead Sciences Inc., has experienced problems with production and distribution since winning an emergency use authorization from the FDA almost two weeks ago.

"We need to have a strategy and plan in place now to make sure we can not only fill that vaccine, make it [and] distribute it, but administer it in a fair and equitable plan," Bright said. "We don't have that yet and it is a significant concern."

Democratic lawmakers at the hearing repeatedly slammed the administration's failure to effectively respond to the pandemic, while their Republican colleagues questioned Bright's basis for challenging chloroquine and the timing of the hearing just a week after he filed a whistleblower complaint with the U.S. Office of Special Counsel over his removal.

Bright's May 5 complaint asks the OSC to reinstate him and investigate whether he was pushed out for advocating scientific solutions over unproven drugs touted by the Trump administration. On May 8, the OSC said that there were "reasonable grounds" to believe Bright's removal was retaliatory.

On Thursday, President Donald Trump denounced Bright as "a really disgruntled, unhappy person."

"I don't want to meet him, but I watched him, and he looks like an angry, disgruntled employee who, frankly, according to some people, didn't do a very good job," the president told reporters outside the White House.

And despite the unfavorable research on hydroxychloroquine's usefulness for COVID-19, Trump doubled down on Thursday, insisting without evidence that there has been "tremendous response to hydroxychloroquine" and that "a lot of people have sworn by it."

HHS Secretary Alex Azar said Thursday that Bright's allegations "do not hold water."

Robert Kadlec, assistant secretary for preparedness and response at HHS, removed Bright from his position at BARDA on April 20. Bright was shifted to a post with less sway at the National Institutes of Health — a move that Bright said was fueled by the agency's contempt for his resistance to the Trump administration's politicization of and reckless disregard for scientific research.

In a statement Thursday, HHS maintained that it was Bright himself who requested an emergency use authorization from the FDA for using donations of chloroquine in the strategic national stockpile to treat COVID-19 patents.

"Bright praised the members of his team for their work to acquire chloroquine on multiple occasions, and characterized those efforts as a success for HHS as a whole," the agency said in a statement.

"I was directed as the BARDA director from the office of the HHS secretary to put in place an expanded access program to make chloroquine donation from Bayer available to Americans," Bright told lawmakers on Thursday.

"My concerns around the safety of hydroxychloroquine in people infected with the COVID-19 virus were reflective of the scientific review that we received from an interagency group of clinicians, regulatory reports and scientists," he said.

--Editing by Jack Karp.

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