After a series of controversial decisions by the FDA so far in the COVID-19 pandemic, questions have circled over whether politics are entering the agency's decision-making process. Aware of questions and criticisms surrounding the agency, key FDA leaders are pledging to always put science first.
In a USA Today op-ed, eight senior career officials said they “absolutely understand” that the agency faces political pressure, but that they will always use “sound science” as a “guide to navigate controversial waters.”
“We will work with agency leadership to maintain FDA’s steadfast commitment to ensuring our decisions will continue to be guided by the best science,” the leaders wrote. “Our approach has been and must remain the gold standard that all can rely upon."
The leaders oversee more than 17,000 employees and have more than 100 years of combined experience at the agency.
While they didn’t specifically touch on vaccines in the op-ed, the agency's reviews of immunizations will be among its biggest decisions amid the pandemic. President Donald Trump has indicated a vaccine is coming soon—possibly before the November election—and programs from Pfizer and Moderna are already in phase 3. AstraZeneca also has a phase 3 trial underway, but it's currently paused for a safety review.
As the leaders know, trust in the agency is “vital.” If Americans don’t trust the agency, they’ll be less likely to use FDA-approved products or enroll in clinical studies, they wrote.
But that trust has been faltering, a new Kaiser Family Foundation survey shows. The group found that 62% of Americans believe the Trump administration will pressure the FDA to approve a vaccine that isn’t proven to be safe and effective. About 39% of Americans think the FDA and CDC are giving “too much attention” to political considerations, the survey found.
The FDA has stoked those worries with controversial moves in recent months. In August, the agency issued an emergency use authorization for convalescent plasma to treat hospitalized COVID-19 patients. In doing so, FDA commissioner Stephen Hahn said the treatment was associated with a “35% improvement in survival.” The number was inaccurate, and Hahn later said he intended to describe a “relative” risk reduction rather than an "absolute" risk reduction.
But the treatment hadn’t been tested in a controlled trial, so experts said there wasn’t enough evidence to claim any benefit. As prominent physician Eric Topol saw it, the move was part of a trend. He wrote an op-ed calling on Hahn to “tell the truth or resign.”
Before the plasma controversy, the FDA issued an emergency use authorization for hydroxychloroquine based on limited evidence. It later revoked the EUA when studies didn't show a benefit for the drug.
Meanwhile, the FDA leaders aren't the only ones looking to reassure the public that they're basing their decision-making on science. The op-ed follows close on the heels of a rare joint pledge from 9 biopharma companies to follow the data and not rush their vaccine programs.