Celine Castronuovo and Jeannie Baumann, Bloomberg Law, August, 26, 2022
A House report detailing coordinated attempts by Trump White House officials to influence the FDA’s pandemic response underscores the need for more transparency at an agency that’s facing historically low public trust, health policy analysts say.
The House Select Subcommittee on the Coronavirus Crisis said this week that advisers to former President Donald Trump sought to build support for hydroxychloroquine as a Covid-19 treatment, despite limited evidence on its efficacy. The report serves as a reminder of how allegations of behind-the-scenes political pressure can influence the public’s perception of federal health agencies’ independence.
“When things are happening behind closed doors, it’s easier for people to try to mess with the FDA,” said Joshua M. Sharfstein, who served as the FDA’s second-in-command during the first two years of the Obama administration.
“The more transparent FDA is, the harder it is for someone to come in and try to interfere with decisions,” he added.
The report comes as positive ratings of the US public health system dropped by nearly 10 percentage points over the past decade, according to a May 2021 joint study by the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health.
Former federal officials and policy watchers say the FDA must maintain transparency in decision making to prevent external influence, especially as the agency oversees several ongoing health priorities—including authorization requests for omicron-specific Covid-19 vaccines and responses to the growing monkeypox outbreak.
The latest findings have garnered mixed reactions, with some policy watchers saying it shows the FDA defended scientific evidence in the face of efforts to politicize health policy. Others say any reports of attempted political interference is damaging to public trust in the FDA and other agencies.
FDA Commissioner Robert M. Califf has said he will make combating health misinformation a priority of his tenure. And “throughout the pandemic, the FDA career staff has worked around-the-clock to make the best, science-based decisions on behalf of the American people in a rapidly evolving and unprecedented public health emergency,” agency spokesman Michael Felberbaum said in an emailed statement.
The subcommittee’s document, which also alleges efforts to promote convalescent plasma as a Covid-19 treatment ahead of the 2020 Republican National Convention, marks the second in a series unveiling findings from an investigation into Trump administration interference with federal health agency pandemic responses.
Many of the Trump administration’s alleged attempts to interfere happened behind closed doors, though the report found the FDA stood up to pressure to keep hydroxychloriquine around after data showed it lacked efficacy as a Covid-19 treatment. The FDA authorized the drug in March 2020 as a treatment for certain hospitalized Covid-19 patients. It revoked the emergency use authorization in June 2020.
Meanwhile, the FDA muscled guidance past the White House that made clear the agency wouldn’t let politics tamper with its decisions, all while facing pressure to authorize vaccines before the 2020 election.
Former FDA Commissioner Stephen Hahn said in an interview with the subcommittee that chief of staff Mark Meadows and other White House officials had “objections” to vaccine guidance language requiring that manufacturers submit at least two months of follow-up safety data for late-stage clinical trials. Hahn said he resisted attempts to change the guidance because “any changes would be obviously reported and would further reduce vaccine confidence.”
Califf’s efforts to highlight the dangers of the pandemic’s rise in health misinformation is one way to rebuild public trust in the FDA, although the overall effort will be a challenge, policy analysts say.
“There are some people for whom I think it will be difficult, if not impossible, to regain their trust,” Diana Zuckerman, president of the National Center for Health Research and a former senior policy adviser to the Clinton White House, said. “It’s not really that much the fault of anything that the FDA did; it’s the fault of the misinformation they’re getting from news sources or social media.”
Califf wrote in an Aug. 22 article in the Journal of the American Medical Association that “the global information environment has been contaminated by misinformation and disinformation.”
“The FDA must be more proactive in preempting and countering misinformation,” he said, adding that there’s also a need for “collaboration across sectors to create an information environment in which decisions” by “consumers, patients, and clinicians are more likely to be informed by reliable information based on high-quality evidence from trustworthy sources.”
Zuckerman argued that “Commissioner Califf has made it clear that he will not let the FDA’s reputation be undermined by misinformation.”
“He’s not going to have a political hack telling him what to do or say, and he’s shown a commitment to focusing on the science and protecting the reputation of the FDA,” she said.
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