FDA leaders: Annual Covid vaccines are likely in our future

By David Lim, Lauren Gardner and Katherine Ellen Foley

Presented by The Pharmaceutical Care Management Association

— Top FDA regulators want to decide by early summer whether Covid-19 vaccines should be updated for the fall.

— FDA publishes its tentative vaccine advisory committee meeting schedule, suggesting kid vaccines may not be available until mid-June.

— Paxlovid failed to protect people from contracting Covid-19 in a late-stage clinical trial.

It’s Tuesday. Welcome back to Prescription Pulse. We didn’t think we’d be going to an electronic dance music concert Sunday night, but thanks to spring weather, those of us in Northeast D.C. got to experience the big beats way past our bedtimes.

Send your vote, tips and feedback to David Lim ( dlim@politico.com or @davidalim), Lauren Gardner (lgardner@politico.com or @Gardner_LM) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley).

A message from The Pharmaceutical Care Management Association:

In the fight to make prescription drugs more affordable, PBMs are the only part of the prescription drug supply and payment chain dedicated to lowering drug costs for patients. In fact, PBMs are lowering patient prescription drug costs by nearly $1,000 every year, enabling safe and seamless prescription drug delivery to patients, and helping patients stay on their medications.
Get the full story and learn more about how PBMs advocate for patients at OnYourRxSide.org.

Getting a Covid shot to protect against new variants could become a yearly routine. | Thomas Lohnes/Getty Images

FDA LEADERS: ANNUAL COVID VACCINE UPDATE LIKELY NEEDED — FDA and its advisers will likely need to consider yearly updates to the Covid-19 vaccine, Commissioner Robert Califf, top vaccine regulator Peter Marks and principal deputy commissioner Janet Woodcock wrote Monday in JAMA.

“It is time to accept that the presence of SARS-CoV-2, the virus that causes COVID-19, is the new normal,” Marks, Woodcock and Califf wrote. “It will likely circulate globally for the foreseeable future, taking its place alongside other common respiratory viruses such as influenza.”

The U.S. must decide by early summer whether vaccines should be updated and who should be eligible for additional booster shots — and consider administering Covid-19 doses alongside the flu vaccines to “protect susceptible individuals against hospitalization and death.” Because of the long manufacturing timeline for Covid-19 vaccines, composition decisions need to be settled by June. FDA advisers are scheduled to meet June 28 on the topic.

“To date, the original, or prototype, vaccine composition deployed has been reasonably good at protecting against severe outcomes from COVID-19,” the regulators wrote. “However, a greater depth and duration of protection might be achieved with a vaccine covering currently circulating variants.”

FDA RELEASES ‘TENTATIVE’ ADVISORY MEETING SCHEDULE — FDA released its “tentative” June meeting schedule — with emphasis on the word tentative — on Friday for its vaccine advisory committee. The lineup will cover several outstanding Covid-related items, including the strain composition for the vaccines come fall and Novavax's emergency use authorization request for an adult Covid vaccine.

But the dates set aside for kids’ Covid shots — June 8, 21 and 22 — are drawing the most attention since they mean the earliest a vaccine will be available for children under 5 is midmonth. Still, Moderna has said it will likely take until later this week to complete its data submission to FDA, and that’s when agency reviewers can begin tackling the application in earnest.

INGLESBY DEPARTING BIDEN ADMIN — Tom Inglesby, the federal official in charge of the Biden administration’s Covid-19 testing efforts, has returned to his full-time job as director of the Johns Hopkins Center for Health Security, David reports.

He will continue to serve as an adviser to the White House Covid response team until early June, according to a source familiar with the process granted anonymity to discuss the personnel timeline. The White House is working to hire a new testing lead and aims to have the individual installed and working before Inglesby fully departs.

PFIZER: PAXLOVID FAILS AS PREVENTATIVE POST-EXPOSURE — Paxlovid, Pfizer’s Covid antiviral pill regimen, failed to adequately prevent people living in the same households as someone with Covid-19 from contracting the disease in a clinical trial, Pfizer said late Friday. The company studied 2,957 adults who had negative rapid test results and no symptoms within 96 hours of being exposed to Covid-positive household contacts. The exposed subjects took five- or 10-day courses of Paxlovid or 10 days of a placebo.

“While we are disappointed in the outcome of this particular study, these results do not impact the strong efficacy and safety data we’ve observed in our earlier trial for the treatment of COVID-19 patients at high risk of developing severe illness, and we are pleased to see the growing global use of PAXLOVID in that population,” Pfizer Chairman and CEO Albert Bourla said.

Paxlovid and the VP: Vice President Kamala Harris’ Paxlovid prescription drew attention last week to a pandemic tool that had largely been overshadowed by vaccine messaging and supply woes. It also raised questions among some doctors about whether the drug can and should be prescribed to asymptomatic Covid patients, based on how the EUA is written.

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SCOTUS DRAFT SHOWS ABORTION RIGHTS OVERTURNED — The Supreme Court has voted to strike down the landmark Roe v. Wade decision, according to an initial draft majority opinion written by Justice Samuel Alito circulated inside the court and obtained by POLITICO, Josh Gerstein and Alexander Ward report.

The draft creates new urgency for advocacy groups working to distribute educational, medical and legal information about mail-order abortion pills for which FDA loosened restrictions in December.

A message from The Pharmaceutical Care Management Association:

GOP UNVEILS NEW HEALTH PLATFORM — The House GOP Healthy Future Task Force on Friday debuted a one-page policy platform that diverges significantly from certain Trump-era proposals like international price indexing. But it keeps some familiar proposals favored by the drug industry like having health plans share drug discounts with patients at the pharmacy counter and device-industry priorities like speeding Medicare coverage for breakthrough medical devices.

“The plan released takes the GOP caucus back to where it was on drug pricing before the Trump Administration proposed far more Draconian proposals and repeatedly chastised drug makers for their pricing,” Cowen Washington Research Group’s Rick Weissenstein wrote in a research note.

The policy plan also calls for establishing an out-of-pocket cap and spreading drug costs over a year for older adults and people with disabilities, targets pay-for-delay tactics and floats curbing CMS’ authority to limit coverage of treatments.

Republicans in Congress are asking CMS why it restricted Aduhelm coverage. | Biogen via AP

REPUBLICAN LAWMAKERS ASK CMS TO DEFEND LIMITED COVERAGE OF ADUHELM — Sens. Richard Burr (R-N.C.) and Mike Crapo (R-Idaho) and Reps. Cathy McMorris Rodgers (R-Wash.) and Kevin Brady (R-Texas) on Monday asked the Centers for Medicare and Medicaid Services to answer questions about its decision to restrict coverage of Aduhelm and for future monoclonal antibodies that target amyloid to treat Alzheimer’s disease.

In the letter addressed to CMS Administrator Chiquita Brooks-LaSure, the lawmakers urge CMS to reconsiderits decision to only cover Aduhelm for those enrolled in clinical trials through FDA or the National Institutes of Health. They also expressed concerns about Medicare’s coverage of future anti-amyloid therapies, which would require patients to be in a similar trial or a patient registry, depending on how FDA approves the drugs.

Private insurance follows suit: UnitedHealthcare, the largest insurance company in the U.S. by revenue, elected to similarly restrict its coverage of Aduhelm starting in June, STAT first reported Monday. “Consistent with the National Coverage Determination recently finalized by CMS, we will only offer coverage of Aduhelm for Medicare members who are enrolled in approved clinical trials of the drug and for Medicaid members when directed by a state,” the company told Katherine via a spokesperson.

WICKER PRESSES BIDEN ADMIN TO FILL OSTP DIRECTOR POSITION — Sen. Roger Wicker (R-Miss.), the Commerce Committee’s ranking member, urged the Biden administration on Monday to fill the top leadership position at the White House Office of Science and Technology Policy. Sociologist Alondra Nelson stepped in to carry out director duties after Eric Lander resigned in February amid reports of bullying, though it’s not a permanent role.

“Until this post is filled, OSTP’s leadership will be encumbered by the lingering allegations of misconduct against Dr. Lander and the senior leadership that still remains at OSTP,” Wicker wrote.

SUBSCRIBE TO NATIONAL SECURITY DAILY : Keep up with the latest critical developments from Ukraine and across Europe in our daily newsletter, National Security Daily. The Russian invasion of Ukraine could disrupt the established world order and result in a refugee crisis, increased cyberattacks, rising energy costs and additional disruption to global supply chains. Go inside the top national security and foreign-policymaking shops for insight on the global threats faced by the U.S. and its allies and what actions world leaders are taking to address them. Subscribe today.

FDA ISSUES DEAR COLLEAGUE LETTER FOR FY 2023 PDUFA PROGRAM — FDA emailed a request to drug manufacturers for updated contact information and products eligible under the Prescription Drug User Fee Act on Monday in anticipation of Congress reauthorizing the PDUFA VII agreements. Companies have until June 1 to respond.

CDRH WANTS TO ORDER PHILIPS TO SUBMIT REPAIR, REFUND PLAN — FDA proposed an order Monday that would require Philips Respironics to “submit a plan for the repair, replacement, or refund of the purchase price” of recalled CPAP, BiPAP and ventilator devices made after Nov. 2015.

STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today.

CMS RULE TO LOWER COST-SHARING BURDEN AT PHARMACIES — CMS released a final rule Friday for the Medicare Advantage and Part D prescription drug programs, aiming to lower out-of-pocket costs for beneficiaries. The rule would require Part D plans “to apply all price concessions they receive from network pharmacies to the negotiated price at the point of sale, so that the beneficiary can also share in the savings.”

TUESDAY: Biogen holds its Q1 earnings call at 8 a.m. EDT.

THURSDAY: BD holds its Q2 earnings call at 8 a.m. EDT. Illumina holds its Q1 earnings call at 5 p.m. EDT.

Bakul Patel, FDA chief digital health officer of global strategy and innovation, announced on LinkedIn he is leaving the agency at the start of May.

Leslie Trigg was elected chair of the Medical Device Manufacturers Association board of directors at the trade group’s annual meeting.

FDA issued draft guidance Monday on using circulating tumor DNA for early-stage solid tumor drug development.

CMS issued a final rule Monday on Affordable Care Act notice of benefit and payment parameters for 2023.

A message from The Pharmaceutical Care Management Association:

Pharmacy Benefit Managers, PBMs, are working on behalf of 266 million Americans with health insurance to reduce prescription drug costs, expand access to medications, and improve patient outcomes.

Here are the key facts to know about PBMs:

· PBMs negotiate with drug companies to lower prescription drug costs, reducing patient drug costs by nearly $1,000 each year.
· PBMs work with pharmacies to deliver prescription drugs to patients safely and seamlessly.
· PBMs help patients stay on their prescription drugs to live healthier lives.
· PBMs advocate for patients in the fight to keep prescription drugs accessible and affordable.

Learn how PBMs advocate for patients at OnYourRxSide.org.

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