With Evan Peng

TEPID COVID VAX UPTAKE — Despite federal health authorities pushing updated Covid-19 vaccinations, manufacturers are bracing for lukewarm demand ahead of the respiratory virus season.

“We have come through the period of fear that defined the early days of Covid where everybody wanted to be vaccinated very quickly,” Albert Bourla, Pfizer’s CEO, said in a call with investors Monday. “We are right now in the middle of Covid fatigue where everyone wants to forget about the disease, and we are experiencing a peak of anti-vaccination retort.”

The company said last week it had adjusted its predicted Covid vaccination sales for the year by $2 billion to reflect lower demand than it initially anticipated. Moderna and Novavax, which also have updated Covid shots, said they believe it is too soon to predict how many people will seek vaccinations.

As of Monday morning, about 8 million individuals have received an updated XBB Covid-19 shot, Ilse Zuniga, a spokesperson for HHS, told Prescription Pulse. The figures come from providers and distributors that have voluntarily reported vaccinations to the federal government because the Centers for Disease Control and Prevention halted Covid vaccine tracking when the public health emergency ended in May.

The mRNA shots from Pfizer-BioNTech and Moderna have been available for roughly four weeks, and Novavax’s protein-based shot received a green light earlier this month. By comparison, the Biden administration estimated that roughly 13 to 15 million people ages 12 and older had received an updated vaccine at this time last year.

What about other Covid products? Pfizer said last week that its sales of the antiviral therapy Paxlovid have also dwindled, leading the company to predict the drug will bring in about $7 billion less in revenue than it initially estimated. The company will begin selling the therapy on the commercial market in November. Lagevrio, Merck’s Covid antiviral, will also transition to the commercial market at that time.

“Those who are getting vaccines and medicines in the current environment are people who believe in the value of protection and treatment and will continue this treatment in the year to come,” Bourla said.

IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE and to peak fall foliage season in the DMV.

Send news, tips and autumnal views to Lauren Gardner ([email protected] or @Gardner_LM), David Lim ([email protected] or @davidalim) and Katherine Ellen Foley ([email protected] or @katherineefoley).

TODAY ON OUR PULSE CHECK PODCAST, host Megan R. Wilson talks with POLITICO health care reporter Ben Leonard, who previews the health care policies at the center of some Senate hearings this week and describes how action on health care issues continues in the House behind the scenes despite the House speaker chaos playing out in public.

MENTHOL CIGARETTE BAN AT THE WHITE HOUSE — The FDA’s revised proposed rules banning menthol cigarettes and flavored cigars reached the White House on Friday for final review. After the rules go through the Office of Management and Budget, they will be formally published.

“Finalizing these two product standards remains a top priority for the FDA,” Brian King, director of the FDA’s Center for Tobacco Products, said in a statement to Prescription Pulse.

The rules, intended to encourage smoking cessation, had been slated to be finalized in August. It often takes roughly six weeks for the White House to conduct its final review of new regulations. It will be a year after the rule is finalized before the ban goes into place, and experts expect the tobacco industry to sue the FDA over the rules in the meantime.

RITE AID FILES FOR BANKRUPTCY PROTECTION — Rite Aid filed for Chapter 11 bankruptcy protection in New Jersey on Sunday amid legal battles over accusations that its pharmacies filled thousands of unlawful prescriptions for drugs, including opioids, POLITICO’s Evan Peng reports. On top of those lawsuits, one of which was brought by the Justice Department in March, Rite Aid faces flagging sales and growing debt.

According to the company’s bankruptcy filing, Rite Aid has more than 2,000 stores remaining open nationwide following several recent closures. In response to an inquiry, a company spokesperson confirmed that, as part of a restructuring, Rite Aid intends to close certain underperforming stores to save on rent but would not confirm how many locations that will affect.

PHARMACY LEGAL GROUP TO TARGET PBM FEES — The National Community Pharmacists Association has launched a company to pursue arbitration and litigation against pharmacy benefit managers it claims have assessed “junk” direct and indirect remuneration, or DIR, fees on pharmacists.

The company, called TRUST, will investigate claims from individual pharmacies, which NCPA said typically don’t have the resources to take PBMs to court.

“The way the contracts are set up, arbitration for claims like these can top $1 million for a single pharmacy,” NCPA CEO B. Douglas Hoey said in a statement. “It’s still not an even playing field, but we have a much better chance of getting justice if we join forces.”

A CMS rule going into effect in January ends the payers’ ability to claw back DIR fees after a Medicare Part D drug has been sold, instead requiring they be collected at the time of sale.

“In Medicare, pharmacy DIR programs reduce out-of-pocket costs and improve patient health outcomes,” said Greg Lopes, a spokesperson for the PBMs’ lobbying group, the Pharmaceutical Care Management Association. “In the commercial market, the programs protect health plans and patients from drug price variation.”

COMPANIES GET $500M FOR VACCINE, THERAPY DEVELOPMENT — The HHS and the White House announced Project NextGen has given more than $500 million to companies developing next-generation vaccines and therapies.

“The technologies that [the Biomedical Advanced Research and Development Authority] is investing in, from intranasal vaccines to self-amplifying mRNA, will bolster our protection against Covid-19 for years to come,” Dawn O’Connell, assistant secretary for Preparedness and Response, said in a statement.

Funds will be spent on vaccines that may have stronger, broader or longer-lasting response, technologies to speed monoclonal antibody development, more efficient virus testing, genomic sequencing and more.

FDA UPDATES NEONATAL MACHINES — Newly manufactured neonatal incubators made by GE HealthCare received after Sept. 5 do not need to be run for a week before they are used because the company “implemented a process to reduce the levels of formaldehyde from new neonatal incubators before distribution,” according to the FDA.

GE HealthCare hasn’t received reports of patient injury tied to potential formaldehyde exposure in incubators.

“At the present time there is not evidence that the levels of formaldehyde observed in GE HealthCare incubators have led to adverse health effects,” the FDA wrote in an updated letter to health care providers.

Cliff Douglas has been named president and CEO of the Foundation for a Smoke-Free World, an organization created by the tobacco giant Philip Morris International to reduce tobacco deaths, though the company is no longer affiliated with the group. Douglas formerly served as director of the University of Michigan Tobacco Research Network.

The FDA is working on rules that could ban certain hair-straightening products due to health risks, Gray news staff for Arizona’s Family.

The FDA indicated it would require Aldeyra Therapeutics to conduct an additional clinical trial before approving the company’s dry-eye treatment candidate, Nicole DeFeudis reports for Endpoints News.

The FDA published draft guidance for drugmakers developing drugs to treat diabetic foot infections.

The FDA issued immediate-in-effect guidance alerting pharmaceutical companies and pharmacists that the agency is concerned that drugs containing ethanol or pharmaceutical alcohol could be vulnerable to methanol contamination.