With Megan R. Wilson

Programming note: We’ll be off this Monday for Juneteenth, but we’ll be back in your inboxes on Wednesday.

ALL EYES ON XBB — The FDA’s expert panel on vaccines voted unanimously Thursday to recommend that fall Covid-19 boosters protect against the XBB strain of the virus — an Omicron subvariant and the most prevalent strain worldwide.

The Vaccines and Related Biological Products Advisory Committee also agreed that manufacturers should use XBB.1.5 as the specific descendant lineage, which makes up roughly 40 percent of Covid cases in the U.S.

The recommendation was in line with what FDA scientists had suggested in their agency presentation. The agency still has to formally direct industry to follow suit, but it often follows its advisers’ guidance. Peter Marks, director of the agency’s Center for Biologics Evaluation and Research, said, pending data from manufacturers, he anticipated the updated boosters to be rolled out in September.

Scheduling conflicts: Marks said he hoped that by adopting a flu-like model in which people get an updated Covid booster this year, more eligible people would get vaccinated. Only 17 percent of those eligible have received bivalent boosters, which were the latest shots federal health authorities endorsed.

But advisers argued Thursday it was too soon to be considering annual shots. “We don’t really know what the Covid season is,” said committee member Mark Sawyer, a pediatrician and an infectious disease specialist at the University of California, San Diego, School of Medicine.

The booster debate: The independent experts also said it wasn’t clear whether everyone would need annual boosters like flu shots and having both on the same schedule might confuse the public. With Covid, “it is likely you could be protected for years against serious to mild illness,” Paul Offit, an attending physician at the Children’s Hospital of Philadelphia and a member of the advisory committee, told Prescription Pulse after the meeting. That’s not the case with the flu, in which annually updated vaccines are strain-specific.

Offit said it was premature to say the general population of healthy adults and children will need them without understanding how much individuals will benefit from updated boosters. The benefit of the first Covid vaccines overwhelmingly outweighed the risks, which included swelling of the heart or surrounding tissue in some young adults, he said, but “if it’s not really helpful, then the safety issues become more exaggerated.”

A flexible approach: FDA officials assured the committee that recommendations for the future were not set in stone.

“If something changes in six months or four months or nine months, we will adjust to it,” Jerry Weir, director of the FDA’s Division of Viral Products in the Office of Vaccines Research and Review, said in the panel’s meeting.

IT’S FRIDAY. WELCOME TO PRESCRIPTION PULSE. Congratulations to the Republicans for their 16-5 victory at the annual Congressional Baseball Game.

Send news and tips to David Lim ([email protected] or @davidalim) or Katherine Ellen Foley ([email protected] or @katherineefoley).

TODAY ON OUR PULSE CHECK PODCAST, host Alice Miranda Ollstein interviews Megan Messerly about Arkansas’ speedy approach to removing ineligible people from the state’s Medicaid rolls —and the confusion among many eligible residents who lost their coverage because of procedural reasons like not properly submitting paperwork.

SPRING CALENDAR DROPS — FDA nerds rejoice: The Spring 2023 Unified Agenda dropped this week. The semiannual list lays out the priorities for the FDA and other federal agencies in the coming months, including estimates for when hot-button regulations are expected.

Here are a few we’re keeping an eye on:

— The FDA still plans to finalize a ban on menthol cigarettes and flavored cigars by August. A proposed rule to establish a maximum nicotine level for cigarettes and some other tobacco products is expected to be released in December.

— The CMS appears to be planning to release its Transitional Coverage for Emerging Technologies notice this month. The long-awaited regulation, which will include a request for public comment, will outline how CMS plans to implement the national coverage determination process for new products.

— The EPA plans to finalize regulations governing commercial sterilizer use of ethylene oxide — a carcinogenic gas used to sterilize medical devices — in March 2024. It also plans to issue a proposed rule on hospital use of ethylene oxide in February 2024 and a subsequent final rule in June 2025.

— Former FDA Commissioner Scott Gottlieb’s favorite deregulatory push — revoking standards for frozen cherry pies — is set to be finalized in November.

FINANCE COMMITTEE IN ON PBM ACTION — A bipartisan group of lawmakers introduced the first in a series of Senate bills aiming to rein in pharmacy benefit managers, the pharmaceutical middlemen that manage prescription drugs for health insurers, and more legislation is on the horizon, Megan reports.

Senate Finance Chair Ron Wyden (D-Ore.) told reporters, “We will definitely have more coming” as part of a package he is working on with ranking member Mike Crapo (R-Idaho).

“We’re going to have a very comprehensive effort to make sure that the middlemen — who performed, in my view, a useful function years ago — aren’t continuing to milk the system of profits that ought to really be rate relief for patients,” Wyden said.

The legislation would ban PBMs from tying their compensation to a medicine’s list price in Medicare, an action supporters say would remove incentives to steer Medicare Part D plans toward higher-priced drugs to secure larger fees or rebates.

The Pharmaceutical Care Management Association, which represents PBMs, pushed back on the bill, saying it undermines the industry’s role in negotiating discounts on drugs — taking away the “only real check against drug companies’ otherwise unlimited pricing power.”

FDA FUNDING BILL INCHES FORWARD — The House Appropriations Committee advanced its fiscal 2024 FDA spending bill Wednesday by a 34-27 vote despite vocal opposition from Democrats over language related to abortion pill access and limits on tobacco regulation. Efforts to strip the provisions from the funding bill failed during a daylong markup.

The Senate Appropriations Committee will mark up its own FDA funding bill next Thursday, and major differences between the two chambers will have to be resolved before government funding runs out on Sept. 30.

HEALTH SPEND TO HIT 20 PERCENT OF GDP BY 2031 — Health care expenditures are expected to grow 5.4 percent annually on average from 2022 to 2031 compared with an average 4.6 percent annual growth rate for nominal gross domestic product, according to a study from CMS’ Office of the Actuary published in Health Affairs. The result: Total health spending as a share of GDP would reach 19.6 percent by 2031.

But spending on prescription drugs is projected to increase an average of 4.6 percent over the same period, POLITICO’s Kelly Hooper reports.

Stephanie Caccomo will leave her position as media relations director at the FDA to join AstraZeneca to be a director of global corporate communications on its respiratory and immunology team.

The FDA published final guidance containing recommendations for companies on documents that should be included in premarket submissions for medical device software functions.

The FDA also published guidance outlining recommendations for questionnaires used to screen potential donors of source plasma.