Some healthcare experts and leaders expressed confusion about the FDA's decision to remove the need for a positive COVID-19 test before Paxlovid or Lagevrio can be prescribed.
On Feb. 1, the FDA said that "in rare instances, individuals with a recent known exposure (e.g., a household contact) who develop signs and symptoms consistent with COVID-19 may be diagnosed by their healthcare provider as having COVID-19" even if they test negative.
Here are five reactions:
1. Walid Gellad, MD, director of the University of Pittsburgh's center for pharmaceutical policy and prescribing: "Paxlovid is right now the only good option for outpatient treatment of COVID, and the last thing we want to do is give it to people who don't have COVID just for convenience," Dr. Gellad told Endpoints News. "I can understand the desire to get people at high risk the treatment, but it has to be very rare that someone tests negative and is unable to get a PCR or test again the next day and then get treated."
"It seems this is a policy that will address a minuscule slice of underuse and lead to a large increase in overuse," he said.
2. Erin McCreary, PharmD, director of infectious diseases improvement and clinical research innovation at UPMC, and an infectious diseases pharmacist: "This is literal insanity," she tweeted.
3. Lexi Thumann, PharmD, an ID/AMS clinical pharmacist at Mercy Medical Center in Cedar Rapids, Iowa: "I'm guessing to remove barriers to prescribing for rural, underserved populations who can't travel hours to see the doc (virtual visits) and get a confirmation test if they have an obvious, known exposure," she tweeted in reply to Dr. McCreary's tweet. "Only thing I can think of?"
4. Vinay Prasad, MD, professor of epidemiology and biostatistics at the University of California San Francisco: "For too long, our hands were tied giving treatments for diseases to people with those diseases. No longer!" he tweeted. "The new FDA knows that if you even think you might have a disease, treatment is right for you."
5. Michael Ganio, PharmD, senior director of pharmacy practice and quality of the American Society of Health-System Pharmacists: "This change brings the EUA into alignment with other FDA-approved antimicrobials that do not require a specific test result for treatment — only a diagnosis," he told Becker's in an emailed statement. "Pharmacists' authority to prescribe Paxlovid continues which offers patient[s] an additional option when seeking treatment."