Amid doubts about the FDA’s decision-making process during the pandemic, biotech CEOs on the front lines of research are laying out their approach and asking “all parties” involved in the process to adhere to high scientific standards.
For one, the FDA should “maintain its historic independence as the gold-standard international regulatory body, free from external influence,” they wrote. The biotech CEOs also reiterated their commitment to conducting trials under best practices to ensure “credibility." Data releases should be handled at scientific conferences or through peer-reviewed journals, not press releases, they said.
"We believe that public health, and the public’s trust in new medical products, are dependent upon the integrity, transparency and objective assessment of new data as they emerge," they noted.
And during an intense election season, “political considerations should be put aside by Republicans and Democrats alike,” the CEOs said, asking U.S. leadership to assure the public that politics isn’t playing into development and approval for coronavirus medicines and vaccines. Ovid Therapeutics' Jeremy Levin, Alnylam's John Maraganore and Acorda's Ron Cohen were among the helmsmen to sign.
The statement comes after moves at the FDA—including the emergency use authorization for convalescent plasma—sent shockwaves through the biopharma industry.
Late last month, FDA commissioner Stephen Hahn, President Donald Trump and HHS Secretary Alex Azar held a press briefing to unveil that EUA. Trump called the treatment a “historic breakthrough,” while Azar said it was a “major advance.” Hahn said the treatment is associated with a “35% improvement in survival."
But the data for the EUA don’t line up with those statements. In treatment guidelines this week, a panel of NIH experts said there are “no data” to support the use of plasma as standard of care for COVID-19 patients. The FDA relied on data from an uncontrolled study and compared mortality for intubated patients who received plasma with a high dose of antibodies versus those who received a low dose, the NIH pointed out.
After Hahn tried correcting his initial statement, saying the treatment was associated with a “relative” risk reduction, medical experts pushed back and said the uncontrolled study data still don’t support that claim.
For the group of biotech CEOs, it's the right time to double down on their guiding principles.
“If this is done correctly, we will halt the pandemic, save lives, reignite our economy and enable a return to a more normal life,” the CEOs wrote. “We will emerge from this pandemic better prepared to address and react to future biological threats.”