Why was an obscure federal bureaucrat involved in Trump’s emergency hydroxychloroquine authorization?

WASHINGTON — Rick Bright, a bureaucrat at an obscure federal agency, burst onto the political stage this week with allegations that the Trump White House put politics ahead of science to advance an untested malaria drug as a coronavirus treatment — explosive claims that beg the question: Why was Bright involved in decisions about the drug at all?

Bright does not work at the Food and Drug Administration, which governs nearly all of the nation’s decisions about whether medicines are safe and effective. Nor is he a member of the Trump administration’s sprawling coronavirus task force, a body that includes the surgeon general, the director of the Centers for Disease Control and Prevention, and even the undersecretary of transportation.

The Trump administration, though, did involve him in a controversial decision to use an arcane emergency authorization process to beef up U.S. supplies of the malaria drug, hydroxychloroquine. Bright says he pushed back vehemently and was subsequently demoted as a result. The Department of Health and Human Services, which oversees his old post, says Bright was the one who requested the emergency authorization in the first place.

The issue raises a litany of questions about exactly who should have been — and who was — involved in the decision to ramp up supplies of the drug, especially since a STAT review of 10 years’ worth of public emergency authorizations shows that no one in Bright’s role has before been so closely involved. Sources tell STAT, too, that even high-ranking FDA officials were kept out of the loop in this instance.

It also highlights other unknowns, like why the Trump administration chose to pursue an emergency authorization in the first place, what it does, and whether there are any indications that Bright pursued the authorization on someone else’s orders.

Below, STAT unpacks what we know about the decision — and what’s still unclear.

What exactly is an EUA?

Emergency Use Authorizations let federal officials greenlight the use of unapproved medical products in a time of emergency — essentially sidestepping the much longer and more complicated traditional FDA approval process. They’ve been issued during the coronavirus pandemic, for example, to allow for the rapid rollout of Covid-19 tests, face mask decontamination systems, and even plastic face shields.

Emergency authorizations, or EUAs, are not formal FDA approvals and the standard for doling out an EUA is much lower than a traditional drug approval. The law says FDA may issue one if “it is reasonable to believe that the product may be effective” and “the known and potential benefits outweigh the known and potential risks.”

There’s debate as to whether the FDA met those two standards for its hydroxychloroquine EUA, although it’s formal authorization says “based on the totality of scientific evidence available to FDA, it is reasonable to believe that chloroquine phosphate and hydroxychloroquine sulfate may be effective in treating COVID-19, and that … the known and potential benefits of chloroquine phosphate and hydroxychloroquine sulfate … outweigh the known and potential risks.”

EUAs are also much quicker than traditional drug approvals. Rather than weeks or months, the FDA can clear emergency authorizations in just a few hours or days.

EUAs can only be issued after the health secretary has declared a public health emergency, or a similar declaration is made by the Department of Homeland Security or Department of Defense.

The EUA is also notoriously opaque. The formal requests aren’t publicly debated the way typical drug applications are. There are no public meetings like there are for high-profile FDA approval decisions. Often EUAs are reviewed only by a few high ranking FDA officials, like the agency’s top scientist or top drug reviewer.

Was the chloroquine EUA controversial?

Yes. Even before Bright’s claims, former FDA officials had alleged that the EUA for chloroquine was politically motivated.

“The recent issuance of the chloroquine/hydroxychloroquine EUA, in the midst of political pressure and with scant and conflicting supporting evidence, should be of serious concern,” wrote former FDA chief scientists Luciana Borio and Jesse Goodman. “When EUA status is sought or granted seemingly under pressure, it may also open a floodgate of efforts to promote unfounded use of other unproven treatments, risking a perception that special interests can influence FDA decisions.”

The move even prompted a congressional inquiry into the potential politicization of the EUA process. “The FDA must maintain its global status as the gold standard for drug approval and review,” Sen. Bob Menendez (D-N.J.) and Rep. Bill Pascrell (D-N.J.) wrote. “It must not cede its responsibility to base decisions on rigorous scientific evidence. As this pandemic grows exponentially, your agency’s decision-making process must not succumb to political pressure.”

FDA Commissioner Stephen Hahn has denied that charge, telling NBC in an interview: “I have not felt political pressure. I have not exerted political pressure on FDA.”

In a statement, the FDA told STAT the EUA “was prepared by expert FDA career staff and reflects extensive discussions with experts at CDC, NIH, and BARDA who are involved in pandemic response.”

However, the opaque process for approving an EUA makes it difficult to decipher exactly how much internal debate there was over the authorization.

Much of the debate likely centered around whether there was enough evidence to truly find that hydroxychloroquine met the standards necessary to issue an EUA. It’s not unusual for a drug that’s granted an EUA to have minimal testing: Many drugs, for example, are only tested on animals because it would be unethical to test them on humans.

But the data supporting the use of hydroxychloroquine for treatment of Covid-19 is notoriously scant. As of now, there have been no placebo-controlled double-blind studies testing hydroxychloroquine for Covid-19, although the drug maker Novartis announced just this week it would soon embark on the first. Several small observational studies have had mixed results, and another observational, retrospective analysis of the use of hydroxychloroquine in Covid-19 patients, conducted by the Department of Veterans Affairs and academic researchers, recently found that the drug was actually associated with higher mortality rates for VA patients that used the drug, compared to those who didn’t. That study, which was not randomized or placebo-controlled, was published on preprint servers and has not yet been peer-reviewed.

Why did the FDA issue an EUA in the first place? 

HHS says it needed an EUA for hydroxychloroquine and chloroquine because the agency had received millions of donated doses of unapproved versions of the drug. (Similar versions, from multiple manufacturers, are FDA approved, but only to treat other conditions). Because the donated drugs were not FDA approved, HHS needed legal authority to put the drugs into the national stockpile, the U.S. government’s vast supply of emergency drugs and devices kept on hand to respond to pandemics.

There is some debate as to whether the government needed to issue an EUA to accept the donation of the drugs. Outside observers, like Borio and Goodman, for example, have argued that the government could have instead facilitated access to these drugs through FDA’s so-called compassionate use program, a separate government system set up to try to help dying patients get access to experimental treatments that haven’t yet been approved.

But the government was facing an unusual situation, to be sure: HHS was hoping to distribute doses of a drug that the FDA hadn’t technically approved — even though the agency had approved an identical product, made by other manufacturers. And HHS wasn’t just hoping to get the drugs to the American people, like a compassionate use program might do. It also wanted to add them to the national stockpile, so, an EUA likely was the quickest and most legally sound method for doing so.

There are benefits for the drug maker whose products come under emergency authorization, too. Products granted an EUA are legally protected under the Public Readiness and Emergency Preparedness Act, which provides liability protection for companies making products to respond to outbreaks.

Bayer, the drug maker who donated 3 million of its chloroquine product, Resochin, told STAT  that it “did not condition our donation on the approval of an Emergency Use Authorization.” But they added that “an EUA was the most expeditious and appropriate regulatory pathway to ensure the product could be donated to the U.S. government’s efforts.”

Why did Bright’s name appear on the EUA?

It’s certainly not typical for an EUA to bear the name of the head of the Biomedical Advanced Research and Development Authority, the post Bright held before he was demoted. Typically, these requests come from companies directly or from the director of the CDC, which often makes its own tests to detect infectious diseases that then need emergency authorization to be used. There have also been instances in years past of CDC requesting EUAs for products being added to the national stockpile.

In fact, after reviewing more than 100 emergency authorizations issued by the FDA since 2009, STAT could not find another instance of a BARDA director directly requesting one.

But BARDA, an office under HHS, does play a key role in overseeing products added to the national stockpile, so it makes some sense that the request might come from him.

BARDA and the FDA also have a long standing agreement, known as a memorandum of understanding, that allows the two offices to talk about the approval of products that help solve public health emergencies. (FDA officials are otherwise barred from discussing unapproved drugs.) So, BARDA is not entirely removed from the process of securing regulatory approval for products like hydroxychloroquine.

BARDA and its parent office, the Assistant Secretary for Preparedness and Response,  have actually taken on a larger role overseeing the stockpile in recent years: The stockpile was moved out of CDC control to ASPR control in 2018, making it all the more logical that someone at ASPR, like Bright, would request the emergency authorization, rather than the CDC director.

Does Bright’s name appearing on the document invalidate his claims?

Not necessarily. Already there are signs in Bright’s statement that while he requested the EUA, he may have worked behind the scenes to limit its scope.

Bright’s statement says that he “limited the broad use of chloroquine and hydroxychloroquine” and “insisted that these drugs be provided only to hospitalized patients with confirmed COVID-19 while under the supervision of a physician.”

Those phrases appear almost verbatim in the authorization eventually approved by the FDA, which could suggest that Bright pushed the FDA to include those restrictions in the authorization or even included them in his original request. A Politico report Thursday also suggested Bright had been trying to limit the White House’s original request for an EUA that would allow anyone to take hydroxychloroquine without much supervision from a doctor at all.

However, there are also signs that Bright may have been more on board with the emergency authorization than he is now letting on. A former Trump administration official tells STAT that Bright expressed support for the donation of these drugs on internal emails, though STAT has not been able to confirm the existence of those communications.