A medical researcher is criticizing a decision by U.S. regulators to deny his emergency authorization request to use a generic medication prescribed for depression and OCD to treat COVID-19.
In a 27-page memo, the Food and Drug Administration (FDA) claimed the drug in question, fluvoxamine, a selective serotonin reuptake inhibitor (SSRI), was “not persuasive when focusing on clinically meaningful outcomes such as proportion of patients experiencing hospitalizations or hospitalizations and deaths.”
The report concluded that existing data did not justify granting an emergency authorization request for fluvoxamine.
Dr. David Boulware, a medical researcher at the University of Minnesota, drafted and submitted the request and is now criticizing the FDA for rejecting it. He claimed the FDA evaluated the effectiveness of fluvoxamine, a generic drug, according to different criteria than drugs patented by pharmaceutical companies.
In a letter to Peter Stein, director of the FDA’s Office of New Drugs, Boulware argued, “FDA should evaluate clinical trials using the same endpoint definitions for generic drugs as for big pharma. The deliberate creation of [a] two-tiered system is inappropriate.”
At issue is how the FDA defined “hospitalization” when evaluating fluvoxamine compared to the definition used by the agency when considering Pfizer’s paxlovid pill.
Boulware said the former had a more restrictive definition that disqualified important data sets. If the emergency authorization request had included those data sets, fluvoxamine would have appeared more successful as an anti-COVID treatment.
When asked for comment by the Epoch Times, an FDA spokesperson stated in an email that the FDA “was unable to reasonably conclude that fluvoxamine may be effective for the treatment of outpatient adults with COVID-19 to prevent severe disease progression and/or hospitalization.”
Boulware disagrees. He told the Epoch Times that all of the existing studies indicate “fairly conclusively” that there is a significant benefit to fluvoxamine treatment.
“It has about 25% reduction in hospitalization, has about a one-third reduction preventing progression of severe disease,” he said. “The data comes from multiple randomized, double-blind, placebo-controlled trials. And so the data is pretty good.”
Boulware will have the opportunity to resubmit his request for emergency authorization pending future trial results.
