On Sunday, the U.S. Food and Drug Administration issued an emergency use authorization for the use of investigational convalescent plasma for treating COVID-19 in hospitalized patients.
The announcement, which also referred to statistics that appeared to be inflated, followed days of back-and-forth about whether the treatment would be approved, according to reporting from the New York Times.
Although an EUA was expected last week, the Times reported that a number of top health officials stepped in. Dr. Anthony Fauci and National Institutes of Health Director Dr. Francis Collins cited emerging data about plasma as a COVID-19 treatment as being too weak thus far to merit an EUA.
“The FDA determined that it is reasonable to believe that COVID-19 convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalized patients,” said the agency in a Sunday news release.
“I am committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible in order to save lives. We’re encouraged by the early promising data that we’ve seen about convalescent plasma,” said FDA Commissioner Dr. Stephen M. Hahn in the release.
WHY IT MATTERS
Some public health experts continued to reiterate the need for randomized clinical trials for the plasma treatment.
Former Trump Administration FDA commissioner Dr. Scott Gottlieb co-wrote in an op-ed for the Wall Street Journal that the agency’s decision “would have a stronger foundation if patients had participated in a randomized study that looked at patients who received plasma fared better than those who didn’t.”
The Mayo Clinic’s Expanded Access Program for convalescent plasma, which was designed to increase access to investigational convalescent plasma and to evaluate the safety of its continued use, announced on Sunday that it would discontinue enrollment following the FDA’s announcement.
“While the program was never intended to be a randomized clinical trial, in the course of our work, Mayo Clinic and our collaborators observed potential signals of efficacy among a diverse population and chose to share those data,” said Dr. Michael Joyner, lead researcher for the program, in a statement.
More than 66,000 patients have received plasma via the Mayo Clinic so far.
“Our hope is that the safety findings and possible efficacy signals could inform the body of knowledge about the use of convalescent plasma to modify the course of COVID-19. We are facilitating additional collaborative trials and scientific study of convalescent plasma,” Joyner continued.
Sunday’s announcement also came on the heels of moves by the U.S. Department of Health and Human Services to limit FDA premarket review of laboratory developed tests.
On Twitter, Gottlieb noted that the FDA has authorized more than 200 COVID-19 tests under EUAs.
“For a subset of LDTs that pose greater risk to patients, where precision and reliability is medically critical, FDA requires pre-market review. This included tests used to screen for pathogens in a public health emergency. This is long established public health precedent,” Gottlieb wrote.
But because of the new policy, he continued, “FDA’s ability to protect public health could be challenged. FDA might not be able to provide critical advice to test developers or take needed enforcement actions against bad tests. After all, how can FDA take action over something HHS says it doesn’t regulate?”
THE LARGER TREND
Mayo Clinic’s Joyner told Healthcare IT News in May that the Mayo Clinic was pleased to be working with the government and with colleagues on the convalescent plasma treatment program.
“The collaboration of researchers across the nation is the key to realizing the full potential of convalescent plasma treatment,” he said.
The FDA has moved to issue a number of EUAs for tests, devices and treatments as part of the nationwide response to the novel coronavirus.
In June, the agency issued an EUA for a COVID-19 predictive screening tool that relied on artificial intelligence to identify patients with a greater likelihood of hemodynamic instability or respiratory failure.
ON THE RECORD
“We will continue to work with researchers to continue randomized clinical trials to study the safety and effectiveness of convalescent plasma in treating patients infected with the novel coronavirus,” said Hahn in Sunday’s press release.
Kat Jercich is senior editor of Healthcare IT News.
Healthcare IT News is a HIMSS Media publication.
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