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Pfizer’s Paxlovid is still free, for now, after the FDA granted full approval

The Biden administration will continue to handle the distribution of free courses of Pfizer’s Paxlovid treatment for COVID-19 for at least another few months, the drugmaker said, even after the Food and Drug Administration on Thursday granted Pfizer full approval for it. market the pills.

“At this time, the US government will continue to oversee the distribution of PAXLOVID, and US residents eligible for PAXLOVID will continue to receive the medicine free of charge,” Pfizer said in a statement.

Federal officials have previously said the widely anticipated approval of the drug, as well as the exit from the health emergency earlier this month, it would have no immediate impact on the distribution of government-purchased supplies of pills.

“We bought a little bit more in anticipation of a winter surge that never really materialized. And we don’t want the American people to pay twice,” said Dawn O’Connell, chief of the Administration’s Preparedness and Response. strategic, at an event hosted by Health Affairs magazine last week.

O’Connell’s agency, ASPR, has distributed nearly 14 million courses of Pfizer pills to date. About 9.3 million of these have been reported administered to patients across the country.

The Biden administration still has about 9.6 million rounds of pills in its supply that have yet to be distributed.

“If we bought it for them with taxpayer dollars, we want to make what we bought available to them for free, as we promised,” O’Connell said.

Planning to end free Paxlovid

O’Connell said officials were actively planning to end their free supply of Paxlovid, which would mean Pfizer’s drug would go to the commercial market.

This means that Americans’ access to the drug would now become the same as other drugs requiring shipping insurance and pharmacies to fill their prescriptions.

“We were not designed, nor were we expected to continue to do so indefinitely for future generations of vaccines and therapies. And we know we were not funded to do this,” O’Connell said.

Pfizer has not disclosed a list price for its one-time Paxlovid pills to be launched commercially in the United States later this year.

The company had sold it in China for about $292, state media reported in January. The Biden administration had paid about $530 a course for its supply, which is close to the range that outside experts say would have been affordable for the drug.

Pfizer said it wants to “help ensure that appropriate patient support programs are in place” for underinsured Americans who can’t afford the drugs. The United States also plans to cover drug administration costs as part of its “bridge access program” through pharmacies.

Both the drugmaker and O’Connell said the switch will likely happen by the end of this year, dictated in part as government supplies run out. Health authorities are also preparing to end distribution of current government-purchased vaccines, ahead of updates scheduled for this fall.

“There’s a lot of complexity here. So just thinking about this: vaccine, probably in the fall, treatment, probably in late summer or fall, we’re going to start to see that shift,” the then-White House response to COVID-19 Coordinator Dr. Ashish Jha said earlier this month in a webinar published by the journal Annals of Internal Medicine.

No off-label Paxlovid yet

The FDA-approved label for Paxlovid is limited to treating “infected adults who are at high risk for progression to severe COVID-19.”

Physicians generally have the freedom to prescribe completely “off-label” approved drugs for other reasons to their patients, beyond FDA approval.

But because Paxlovid was only allowed under emergency use approval, doctors can’t prescribe the drug for any unapproved reason outside of clinical trials, such as for the treatment long COVID symptoms or to try to prevent infections.

Since all current U.S. supplies of the drug have been labeled with Emergency Use Authorization, this restriction will effectively remain for now.

The agency will continue its emergency authorization to allow Paxlovid for eligible children 12 and older, as well as to allow pharmacists to prescribe it.

“PAXLOVID labeled for use under the Emergency Use Authorization (EUA) remains subject to the terms and conditions of the EUA,” FDA spokesman James McKinney said in a statement.

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