FDA official steps into vaccine vacuum after shakeup

A senior official at the Food and Drug Administration has emerged as the Trump administration’s unofficial vaccine czar after the abrupt ouster of the scientist leading the multibillion federal effort to develop coronavirus treatments, according to three current and former health department officials.

Peter Marks trained as a cancer doctor and now directs the FDA office that oversees the approval of vaccines and gene therapies. HHS has increasingly positioned the quiet, trusted FDA official as an informal adviser to the Biomedical Advanced Research and Development Authority and other agencies on vaccine development.

Giving Marks, who a senior HHS official called “a world-class expert” on vaccines, a more prominent role could ease fears that the recent shakeup at BARDA could slow progress against the pandemic.

The secretive agency vaulted into the spotlight this month after its chief, Rick Bright, was pushed out of the role he’d occupied for more than three years. BARDA is a key player in the Trump administration’s coronavirus response, charged with funneling billions of dollars to the most promising Covid-19 vaccines, treatments and tests. Bright alleged that he was ousted over his opposition to promoting the malaria drug hydroxychloroquine as a coronavirus therapy despite scant evidence.

BARDA’s importance grew after the White House decided to strike out solo on its search for a cure. The U.S. is not participating in a global initiative launched last week by the World Health Organization — which Trump recently promised to defund — to accelerate the hunt for cures and vaccines. BARDA is working directly with drug companies to support the development of products it thinks could prove potent weapons against the virus.

“Someone is going to have to make those investment decisions, but with Peter trying to help,” said the senior HHS official. Gary Disbrow, the BARDA official tapped as the agency’s acting chief, will then become more of a “middle manager,” the official added. Disbrow joined BARDA in 2007 to work on a smallpox vaccine but soon after switched his focus to chemical and nuclear countermeasures, eventually rising to director of that department.

Marks joined FDA in 2012 as a deputy director for the Center for Biologics Evaluation and Research, which oversees vaccines, gene and cell therapies and blood products. He became director in 2016.

Other current and former officials said that Marks is not advising BARDA specifically, but consulting with a range of government agencies — including the National Institutes of Health, at work on its own potential vaccine — about the most promising candidates.

“I’m not surprised that lots of people seek his counsel, across the government,” said a second senior HHS official. “But at the end of the day, he’s one man.”

A department spokesperson said that “in his role as the head of the FDA center that regulates vaccines, Dr. Marks continues to collaborate across the government and industry on the development and availability of a safe and effective COVID-19 vaccine.”

Marks has been asked to accelerate vaccine development work and help coordinate between agencies, said a former government official familiar with the discussions.

Bright stood as another vaccine expert in the upper echelons of the health department before he was abruptly demoted last week from BARDA chief to working on “point of care” coronavirus testing at the NIH. The scientist, who joined the agency during the Obama administration, has alleged that he was pushed out for political reasons related to his hesitancy over the use hydroxychloroquine, which the president has touted as a coronavirus cure despite a lack of evidence.

Bright’s ouster has riled administration allies and Democrats alike — including House Speaker Nancy Pelosi, who demanded an investigation into his allegations that politics, not science, were driving choices like hydroxychloroquine’s emergency use.

Former FDA Commissioner Scott Gottlieb said Sunday that the decision to remove Bright would hamper the country’s race to find a viable vaccine. "I think changing leadership in that position right now certainly is going to set us back," he said.

"When something like this happens, it raises questions about how reliable a partner the U.S. government is going to be — and what sorts of pressure they are going to be under to do things, and thus be unpredictable," said Nicole Lurie, who served as assistant secretary of emergency and preparedness during the Obama administration.

The shakeup at BARDA came just weeks after the agency poured hundreds of millions of dollars into partnerships for potential coronavirus cures, vaccines and tests. Congress also used last month’s stimulus package to more than triple BARDA's $1.5 billion budget and remove limits on its transactions, clearing the way for more private sector partnerships.

The decision to remove Bright had been in the works for months because of his clashes with management and other health officials, POLITICO previously reported. But an HHS official said the final straw was ultimately a Reuters article on leaked emails between HHS officials discussing which agency would get the political “win” for hydroxychloroquine donations.

BARDA so far has handed out $1.3 billion to the makers of possible coronavirus cures, vaccines and tests. Roughly $1.1 billion of those investments went to just three companies: J&J, making a vaccine and treatment, Regeneron, testing two possible drugs, and Moderna, which is working with NIH on a vaccine.

Regeneron and its partner Sanofi received bad news this week about one potentially repurposed treatment, an arthritis drug named Kevzara. After a clinical trial revealed that severely ill Covid-19 patients did not benefit from the drug, an independent panel told the drugmaker to limit the study to the most critically ill patients because they showed some improvement. Kevzara is one of three "IL-6 inhibitors" — autoimmune drugs that block a type of severe inflammation known as a “cytokine storm” — that BARDA invested in under Bright’s tenure.

That decision drew criticism from some who say he unnecessarily doubled down on one type of treatment. But BARDA typically invests in multiple therapies with the understanding that several will fail; it also is supposed to prioritize medicines that could be used for a range of purposes, like existing arthritis drugs that made be useful against coronavirus.

The hope now is that Marks will be able to steer the train on coronavirus vaccines and drugs, not just at BARDA but across the government. Sources stressed that he is not leaving FDA for BARDA, however. “Ultimately we need him to be in the place of supporting the development and approval of biologics and vaccines,” said one official, nodding to his day job as the director of one of FDA’s main divisions.

But for now, much of the effort to find a coronavirus vaccine is centered on the secretive BARDA. Congress has pumped billions of dollars into the agency since its creation in 2006. Lawmakers have also granted it immunity from public records requests to protect the trade secrets of its private partners.

The $31 billion delivered to BARDA in the first coronavirus stimulus package, along with another $16 billion channeled to HHS to bolster the strategic national stockpile, has fired up demands for more accountability on how money is spent. While HHS’s Assistant Secretary of Preparedness and Response manages the stockpile, BARDA recently asked FDA to authorize emergency use of hydroxychloroquine so that the pills could be added to the supply.

“As chair of the subcommittee that funds the NIH and the Biomedical Advanced Research and Development Authority, BARDA, I am deeply aware of how much money the U.S. government is spending on the critical, lifesaving biomedical research in this country,” said Rep. Rosa DeLauro (D-Conn.) in an April 15 call with reporters as she discussed subsequent stimulus packages.

DeLauro and other progressives are demanding that drugmakers account for how they spend any money they receive from BARDA.

Meanwhile, Bright’s critics say that he did not mobilize the agency quickly enough to tackle the coronavirus. For instance, BARDA did not solicit potential investments into coronavirus drugs, tests and vaccines until March, five weeks after HHS Secretary Alex Azar had declared a public health emergency. But Bright did strike a deal with J&J in early February to expand an existing vaccine agreement to include Covid-19.

He also clashed with Assistant Secretary for Preparedness and Response Robert Kadlec, who oversees BARDA, well before the pandemic broke out, according to current and former HHS officials.

Those fights were largely over policy differences. But the situation came to a head when Bright was blamed for an email leak to Reuters revealing conversations between FDA Chief of Staff Keagan Lenihan, HHS director of external affairs Cicely Waters and Joseph Hamel, ASPR’s manager of strategic innovation and emerging technology, about Bayer’s donation of three million chloroquine pills to the national stockpile, according to a current and a former official.

“How do you want to handle? FDA win? ASPR win? Happy either way, please let us know,” Hamel wrote according to the Reuters report.

HHS officials erupted over what was seen as an embarrassingly enthusiastic exchange over drugs that are still unproven for treating coronavirus, but have been championed by President Donald Trump. Within days, Bright was out at BARDA — and alleging in a statement released by his lawyers that his ouster was tied up in the political pressure to tout chloroquine and hydroxychloroquine.

The president has not mentioned hydroxychloroquine, which he used to regularly praise on the press briefing stage, in over a week.

Bright has pledged to file a whistleblower complaint with the HHS inspector general over his removal.

"Whether it’s firing Rick, whether it’s the hydroxychloroquine [emergency use authorization], or other ways in which the scientific and regulatory agencies are put under pressure, all of that just erodes public confidence," said Lurie, the former ASPR head who worked with Bright. "I think [it] could lead to a big backlash when it comes to important things like having confidence in what their agencies will say about the safety and effectiveness of a vaccine."