Clinical trial participant gets injected with an experimental COVID-19 vaccine.
Source: AP Photo
Congress should consider banning the U.S. Food and Drug Administration from granting emergency use authorization to experimental COVID-19 vaccines, a group of legal experts said, citing concerns over political pressure to rush those products to Americans before they are ready.
The recommendation came in a lengthy report from over 50 U.S. legal and policy experts from multiple academic institutions, who outlined a number of concerns with how the nation has handled the COVID-19 pandemic, calling the response a "massive failure of executive leadership."
"Decades of pandemic preparation focused too much on plans and laws on paper and ignored the devastating effects of budget cuts and political interference on the operational readiness of our local, state and national health agencies," the legal experts wrote in the report from the George Consortium's Public Health Law Watch, which was sponsored by the American Public Health Association, the de Beaumont Foundation and the Robert Wood Johnson Foundation.
Congress should look closely at the substantial risk that social or political pressure — or just the overwhelming desire to do good — will influence the FDA to approve a vaccine too soon, they said. "While expediting the process is obviously vital, it is equally important to ensure that the final decision is made by scientists, not politicians facing an election," the experts said.
Congress created the emergency use authorization, or EUA, process in 2004 to grant preapproval use of medical products when the secretary of the U.S. Department of Health and Human Services declares a public health emergency.
HHS Secretary Alex Azar declared such an emergency on Jan. 31 for COVID-19, though it was not made official until Feb. 4. Public health emergencies must be renewed every 90 days — an action most recently taken July 23.
The report's authors acknowledged the FDA is facing an "undeniably difficult task" in a situation where there is an urgent need to move as quickly as possible while also ensuring rigorous evidence has shown the products are safe and effective.
Congress' giving the FDA the EUA mechanism arguably reflects a societal decision that the regulator should have the flexibility to lower standards of safety and effectiveness during public health emergencies to speed access to promising but unproven products, Patti Zettler, associate professor of law at The Ohio State University, and her colleagues wrote in the report.
But the FDA is likely to face tremendous political pressure — whether from the White House, HHS, Congress, industry, patients or other stakeholders — to use that flexibility "and may lose public trust if the agency is viewed as unresponsive to patients' concerns," they wrote.
During the current crisis, the FDA used its EUA authority first on March 28 for the use of hydroxychloroquine and chloroquine in certain hospitalized patients with COVID-19 and on May 1 for Gilead Sciences Inc.'s remdesivir.
But regulators revoked the EUAs for hydroxychloroquine and chloroquine on June 15 after evidence showed the drugs were ineffective in COVID-19.
President Donald Trump
Risking public trust
President Donald Trump had started touting hydroxychloroquine and chloroquine as treatments or preventive medicines in mid-March. The FDA's decision to grant the drugs an EUA came only nine days later, "raising significant concerns about political interference in public health decision making," Zettler and her colleagues noted.
Trump and members of his administration, including his trade adviser Peter Navarro, repeatedly criticized the FDA's decision to revoke the EUAs.
On Aug. 19, The New York Times reported that the FDA had considered granting an EUA for convalescent plasma to treat COVID-19 before top officials at the National Institutes of Health expressed concern and intervened.
The NIH did not respond to questions from S&P Global Market Intelligence about the Times' report and declined to make any of the agency's officials available for an interview.
"Per policy, we are not able to comment on whether or not we will take any action regarding emergency use authorization for convalescent plasma," said a spokeswoman for the FDA.
FDA Commissioner Stephen Hahn
Misunderstandings about what an EUA signifies could drive inappropriate policy decisions or undermine public trust in FDA decisions when products granted EUAs prove ineffective or unsafe, Zettler and her colleagues wrote in their report.
Another major concern is that the FDA, "perhaps driven by political pressure, may too freely issue EUAs for COVID-19 countermeasures, even judged against the relatively low statutory standard" for granting them, they said, pointing to hydroxychloroquine and chloroquine as examples.
They called for the FDA to decline to grant any EUAs for COVID-19 vaccines, but if regulators do, the legal experts said that mechanism should be limited for use in individuals with a documented higher than baseline risk of death or serious injury from COVID-19.
FDA Commissioner Stephen Hahn and other top officials at the agency pledged in an Aug. 7 article in the Journal of the American Medical Association to hold a public meeting with an outside expert panel to vet any COVID-19 vaccine before it was authorized for emergency use or licensed in the U.S.
But in an Aug. 18 article in the public policy journal Health Affairs, Hahn and the other FDA officials tweaked their language and said regulators would convene the advisory panel for a COVID-19 vaccine "when data from trials becomes available."
NIH Director Francis Collins told reporters Aug. 13 he did not anticipate any data to be available for the FDA's review until at least November or December.