More FDA Covid Transparency Needed: Professor
University of Minnesota School of Public Health professor Leigh Turner says FDA needs to become much more transparent about the operations of its new Coronavirus Treatment Acceleration Program (CTAP). In an online post at The Conversation, Turner says that “as a specialist in bioethics and public health, I see troubling signs that suggest FDA’s new program for expediting reviews of potential therapies for Covid-19 is not working as it should. In its place, I see signs of political interference, inappropriate pressure to authorize products for emergency use, and an overwhelming surge of clinical studies that challenge FDA’s capacity to carefully scrutinize them before deciding whether they should proceed.”
Turner says the agency has redeployed many staff members to serve on CTAP review teams but has not disclosed how many staff are on the teams or what their professional background and training cover. “If FDA employees are being assigned unfamiliar responsibilities,” he writes, “or are reviewing applications for products beyond their expertise, there’s a risk those reviews will not be sufficiently thorough.”
According to the post, CTAP is an opaque regulatory initiative from which decisions emerge without any information on who made them, why they were made, or what information was provided to FDA. “While some details have been shared,” Turner says, “I believe that, in general, CTAP would benefit from greater transparency.”
He says that while FDA claims it removed “bureaucratic impediments” so it could review many Covid-19 clinical study protocols within 24 hours, it has not indicated what impediments were removed. “What we do know,” he says, is that “FDA has enabled Covid-19 studies to proceed at a far more rapid pace than trials that are testing interventions for other diseases. By doing so, FDA needs to respond to scientists, physicians, bioethicists, regulatory specialists, and other critics concerned that FDA is failing to maintain its regulatory standards.”
With the number of trials rapidly increasing, Turner writes, the public deserves to know much more about how CTAP is functioning. In addition to reporting on the number of Covid applications received and the number cleared to proceed, he said, FDA should also report the number of proposed studies it has declined to review, the number of times FDA has not cleared studies to proceed and has instead imposed holds due to safety issues, and the duration between when IND applications were submitted and when the studies were allowed to proceed or placed on hold. Most importantly, he concludes, the public needs to know more about how decisions are being made within CTAP. “Public understanding of CTAP would increase if FDA identified the clinical studies it reviews and clears, and provided links to listings on ClinicalTrials.gov…. First and foremost, FDA’s rigorous oversight, rather than a race to satisfy an aggressive and perhaps political agenda, is imperative during this pandemic.”