Pfizer’s Paxlovid still free, for now, after FDA grants full approval to COVID drug

The Biden administration will continue to administer Pfizer’s free courses of Paxilvid treatment for at least a few more months, the drugmaker said, even after the Food and Drug Administration. granted Pfizer on Thursday gave full approval to market the pills.

“At this time, the U.S. government will continue to monitor the distribution of PAXLOVID, and eligible U.S. residents will continue to receive PAXLOVID at no cost,” Pfizer said in a statement. release.

Federal officials have previously said that along with the widely expected approval of the drug Ending a public health emergency Earlier this month, the pills will have no immediate effect on the distribution of supplies purchased by the government.

“We bought a little bit more in anticipation of a winter hike that never actually materialized. And we don’t want the American people to pay twice,” said Don O’Connell, head of the Administration for Strategic Preparedness and Response. The ceremony The Health Affairs Journal hosted last week.

O’Connell’s agency, ASPR, What is the distribution? About 14 million courses of Pfizer pills till date. About 9.3 million of these are reported to be administered to patients nationwide.

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

“If we bought it with their taxpayer dollars, we want what we bought to be made available for free, as we’ve been promising,” O’Connell said.

Free Paxlovid Removal Plan

Officials are actively planning to end their supply of free Paxlovid, which would mean Pfizer’s drug, O’Connell said. Commercial market.

That means Americans’ access to the drug will now be similar to other drugs that require insurance and navigating pharmacies to fill their prescriptions.

“We were not designed, nor are we expected to continue this ad for future generations of vaccines and treatments,” O’Connell said.

Pfizer has not disclosed the list price of its Paxlovid tablets after they are commercially launched in the US later this year.

According to state media, the company was selling it in China for around $292. Reported in January. The Biden administration paid $530 per course to provide it, which is close to the limit. Outside experts He said that the investment for drugs will be effective.

Pfizer has said it “intends to help ensure that adequate patient assistance programs are in place” for underinsured Americans who may not be able to afford the drug. The US also plans to cover the administrative costs of the drug as part of this. “Bridge Access Program” through pharmacies.

Both the drugmaker and O’Connell said the switch would likely come by the end of this year, partly dictated by government stockpiles running low. Health officials are preparing to end distribution of the current government-bought vaccine ahead of updates expected this fall.

“There are a lot of complications. So just thinking about: the vaccine, maybe in the fall, the treatment, maybe sometime in the late summer or fall, we’ll start to see that change,” the White House said at the time of the COVID-19 pandemic. 19 response coordinator Dr. Ashish Jha said that earlier this month, A Webinar Published by Annals of Internal Medicine Journal.

There is no off-label Paxlovid yet.

FDA approved. The label Paxlovid is limited to the treatment of infected “adults who are at high risk of developing severe COVID-19.”

Doctors are generally free to prescribe fully approved drugs. “Off Label” For other reasons for their patients, outside of FDA approval.

But because Paxlovid is only allowed under emergency use authorization, doctors could not prescribe the drug for an unapproved reason, such as treatment, except for clinical trials. Prolonged COVID symptoms or to Try to prevent infection.

Since all current US supplies of the drug were labeled under emergency use authorization, the ban will effectively remain in place for now.

The agency will Continue your emergency authorization Authorizing Paxlovid for eligible children 12 years of age and older, as well as allowing pharmacists to prescribe it.

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