By David Lim, Lauren Gardner and Katherine Ellen Foley

Updated Covid vaccines will be available in September, but those who are uninsured will have to wait about another month to get a free shot at a retail pharmacy. | Marcio Jose Sanchez/AP Photo

PHARMACY BRIDGE STILL BEING BUILT — People without Health insurance will likely go weeks after updated Covid-19 vaccines hit the market this fall until they can get a free shot at retail pharmacies. The delay adds a layer of complexity for the uninsured that public health experts worry could discourage people from getting the shot.

The Biden administration is still finalizing contracts with companies, including CVS and Walgreens, to distribute free vaccines to the uninsured, according to CDC spokesperson Kathleen Conley.

The CDC expects the updated vaccine rollout to begin the third or fourth week of September, she said. But the contracts with pharmacies will likely not be finished until mid-October, a timeline the agency maintains was always the plan, as questions swirl about what’s behind the delay.

“I think it’s going to be challenging,” said Claire Hannan, executive director of the Association of Immunization Managers, which helps coordinate immunization programs nationwide. “We’re not expecting high demand; I think we’re really going to have to work to make sure that providers are recommending the vaccine, that the public knows where to get it."

The uninsured will need to go to federal health centers or individual providers for free vaccines during the first stage of the fall vaccination campaign while the administration’s $1.1 billion “bridge” program is stood up in pharmacies.

However, many federally qualified health centers operate as clinical facilities, meaning patients may need to schedule an appointment to get an updated shot, according to Dr. Marcus Plescia, chief medical officer at the Association of State and Territorial Health Officials.

“You’re going to have people showing up at the pharmacy looking to get vaccinated ... and being told we’re not yet prepared to give it to you,” said Dr. Georges Benjamin, executive director of the American Public Health Association. “Some of those people will come back and get vaccinated, and some of those people will just get frustrated and not show up again.”

IT'S FRIDAY. WELCOME TO PRESCRIPTION PULSE. We didn’t appreciate the POLITICO dig in Red, White and Royal Blue, but we’ll still watch it again.

Send news and tips 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 Messerly talks with POLITICO global health reporter Carmen Paun about her Q&A with John Bell, the former U.K. testing czar, who says that governments should increase disease surveillance, develop routine adult vaccination programs and build clinical trial networks in Africa to better prepare for the next pandemic.

Bristol Myers Squibb says the Inflation Reduction Act's Medicare drug-price negotiating provision impinges on their rights. | Mel Evans/AP Photo

DRUGMAKERS OUTLINE OFFENSE IN IRA LAWSUITS — Two of the drugmakers challenging the Biden administration’s Medicare drug price negotiation authority filed motions for summary judgment this week, arguing the program violates their First and Fifth amendment rights. The motions come just weeks ahead of the Sept. 1 deadline for CMS to name the first 10 drugs selected for the first-ever government Medicare drug price negotiations.

In the pair of filings in a U.S. district court in New Jersey, Bristol Myers Squibb and J&J-owned Janssen argue that the Inflation Reduction Act program takes away their private property — in the form of at least two branded drugs, Eliquis and Xarelto — that analysts widely expect to be included in the program’s first wave — for public use without providing just compensation.

They argue the law’s requirement that drugs be sold to Medicare for a percentage of their market price amounts to an illegal government grab that will chill industry R&D investment for new cures.

The companies also maintain the law’s requirement that the makers of selected drugs sign negotiation agreements with Medicare infringes upon free speech by “compelling” them to echo the government’s “political messages.”

“While the public supports negotiating drug prices, it does not support governmental price-setting, especially in the health-care arena,” BMS said in its motion. “Congress thus cloaked the IRA’s price-setting mandates with faux ‘agreements’ to mislead the public about how the Program operates.”

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MENTHOL BAN UNLIKELY THIS MONTH — Experts have dwindling hope the FDA will meet its August target of finalizing its menthol cigarette ban. The FDA proposed the rule in 2022 after years of pressure from public health groups urging the agency to take action.

The rule, which would be the biggest regulation taken by the agency’s Center for Tobacco Products since its 2009 inception, must go through a final White House review before it can be issued. That process often takes at least a month, and as of this week, the rule still hasn’t made it to the executive branch.

It’s not uncommon for agencies to miss their targets for finalizing rules. “I’ve never, not even once, seen CTP … put a date in the rule in the regulatory agenda and [meet] that date,” Desmond Jenson, a lead senior staff attorney at the Public Health Law Center at the Mitchell Hamline School of Law, told Prescription Pulse.

Jenson added that a rule of this magnitude would require complex coordination among several different agencies, which may be why the process is taking longer than anticipated.

Some groups have threatened legal action if the FDA doesn’t finalize the ban by its target date — including the African American Tobacco Control Leadership Council, which previously sued HHS in 2020 for failing to take regulatory action on menthol cigarettes.

“Consistent with the administration’s commitment to advancing the final tobacco product standards on menthol as a characterizing flavor in cigarettes and characterizing flavors (other than tobacco) in cigars, the FDA aims to complete work on these rules as expeditiously as possible,” FDA spokesperson Jim McKinney told POLITICO in an email.

MODERNA TOUTS UPDATED COVID SHOT — One of the biggest Covid vaccine manufacturers said Thursday its updated Covid vaccine “showed a significant boost in neutralizing antibodies” against two variants circulating in the U.S.

Moderna said its preliminary clinical trial data, which it’s submitted to the FDA but not released publicly, suggests the formulation “may effectively target the expected circulating variants of COVID-19 during the upcoming vaccination season.”

RSV VACCINE AVAILABLE — GSK, maker of the first respiratory syncytial virus vaccine for adults ages 60 and older to receive FDA approval, said Thursday that its shot is available in retail pharmacies. Pfizer’s RSV shot for older adults became available in July. Both shots are offered for free under Medicare Part D and most private insurance.

WHO ADVOCATES FOR TRADITIONAL MEDICINE — The World Health Organization said Thursday that countries should integrate traditional medicine into their national health systems provided the treatments are backed by scientific research, POLITICO’s Ashleigh Furlong reports.

SOUTH AFRICA MUST RELEASE COVID SHOT DEALS — A South African court just ordered the government to publish its Covid vaccine contracts and all negotiation documents with manufacturers, rejecting arguments that such a move would hinder future deals. The ruling marks a significant moment in the worldwide push for more transparency around agreements inked between vaccine makers and governments at the height of the pandemic.

Key aspects of an Oklahoma law regulating pharmacy benefit managers were struck down by the 10th U.S. Circuit Court of Appeals, STAT’s Ed Silverman reports.

Blue Shield of California is cutting ties with CVS Health’s Caremark as its primary pharmacy benefit manager and instead will work with several groups, including Mark Cuban’s Cost Plus Drug Company, Tami Luhby and Jordan Valinsky write for CNN.

The FDA approved on Thursday the first treatment for fibrodysplasia ossificans progressiva, a rare disease that leads to extra-skeletal bone formation.

The Peterson-KFF Health System Tracker released on Thursday a comparison of the list prices for weight-loss drugs Ozempic, Rybelsus, Wegovy and Mounjaro in the U.S. and other nations, including Japan and the Netherlands.

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