The FDA has tweaked its emergency use authorization for Pfizer’s COVID-19 pill Paxlovid, allowing pharmacists to provide the antiviral treatment to those who have been recently infected and are at risk for progressing to a severe form of the virus.
The adjustment will allow greater access to Paxlovid—a 30-pill regimen taken over a five-day span that can only be prescribed within a five-day window after patients develop symptoms.
The FDA’s decision comes six weeks after the White House pushed for greater access to the drug. Around the same time, the U.S. opened its first brick-and-mortar test-to-treat site in Rhode Island, allowing patients who test positive to immediately receive oral antiviral pills.
“Fundamentally, what we’re trying to do is get to a point where COVID deaths are largely preventable,” Dr. Ashish Jha, the White House COVID-19 response coordinator, told New York Times in May. “Deaths from this disease really should become increasingly rare.”
The U.S. has purchased 20 million courses of Paxlovid. The drug won FDA authorization in December based on its 89% effectiveness in reducing the risk of hospitalization and death.
But demand has been less than Pfizer expected as it has been hindered by complicated eligibility requirements, reduced testing, the potential for drug interactions and a public perception that omicron infections aren’t as severe.
Pfizer said on Thursday that it expects the measure will improve access to the treatment and “reduce health inequities.”
“Enabling pharmacists to prescribe may help reduce barriers and time to treatment, which is critical as treatment with Paxlovid in eligible patients must be initiated as soon as possible,” the company said in an emailed statement.
The FDA action comes as COVID infections are starting to rise in the U.S. after being at their lowest level since the start of the pandemic. The trend is expected to continue through the summer vacation season.
The American Medical Association criticized the new measure, saying Paxlovid should only be prescribed by physicians with knowledge of a patient’s medical history.
“While the majority of COVID-19 positive patients will benefit from Paxlovid, it is not for everyone and prescribing it requires knowledge of a patient’s medical history, as well as clinical monitoring for side effects and follow-up care to determine whether a patient is improving—requirements far beyond a pharmacist’s scope and training,” the AMA president Jack Resneck, Jr., M.D., said in a statement.
The National Community Pharmacists Association however hailed the announcement, calling it a “course correction,” said CEO B. Douglas Hoey.
“Pharmacists are the drug therapy and drug interaction experts,” Hoey said in a statement. “This move opening up their ability to assess the need for and prescribe Paxlovid will improve patients’ timely access to treatments that will help keep them out of the hospital and alive.”