States work to fill in the blanks of the federal Covid booster program

From: POLITICO's Prescription Pulse - Tuesday Sep 28,2021 04:02 pm

Sep 28, 2021

Presented by the Partnership for America’s Health Care Future

With help from Katherine Ellen Foley

On Tap

— States are working to demystify the CDC’s broad Covid-19 booster recommendations for people initially vaccinated with Pfizer’s product.

— House Democrats are discussing changes to health provisions in their multitrillion-dollar social spending bill in an effort to soften its financial blow.

— The Biden administration is putting off tariff increases for Chinese-made medical goods pertinent to the pandemic.

It’s Tuesday. Welcome back to Prescription Pulse. Send tips and tricks for surviving this week 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).

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Every American deserves access to affordable, high-quality health coverage and care to help them get healthy and stay healthy. Let’s build on and improve what’s working in health care – not start over with an unaffordable, new government-controlled health insurance system like the public option or by opening up Medicare to younger Americans. Learn more

Coronavirus

STATES WRESTLE WITH BOOSTER ROLLOUT AMID BROAD ELIGIBILITY — States are heading into their fifth day of being permitted to hand out Pfizer booster shots, and they’re taking a variety of approaches to promote them. If you’re a West Virginia resident, perhaps you’ve heard GOP Gov. Jim Justice urge essentially anyone 18 and older who got the company’s vaccine earlier this year to get the booster, equating it with easing the strain on hospitals despite the state’s low vaccination rate of 40 percent.

In Alabama, the state’s health officer bemoaned the complexity of the eligibility criteria, especially for the categories of people who “may” opt for a booster depending on their individual risk-benefit analysis. “That’s not a great sound bite that you can put out there,” Scott Harris said.

As of Monday, about 2.78 million Americans had received an additional vaccine dose — either a Pfizer booster or a third Pfizer or Moderna dose if they claimed to have a compromised immune system — according to CDC. That rate has picked up since last week when CDC and FDA formally endorsed Pfizer boosters at least six months after the second dose.

But some state health officials worry the confusion around boosters will cause the already vaccine-hesitant to dig in their heels further, Lauren and Katherine report. Conversely, high demand out of the gate could strain localities simultaneously trying to get shots into previously unvaccinated arms and inoculating the public against the flu.

The next wave: Once Pfizer applies for, and likely receives, emergency use authorization for its vaccine in children ages 5 to 11, another complicating factor will be added to the country’s immunization infrastructure right in the middle of flu season, said Adriane Casalotti, chief of government and public affairs at the National Association of County and City Health Officials.

“You’ll have yet another level of planning that has to happen and strategy ensuring that the right providers are on board,” she said.

AREA MAN GETS BOOSTER SHOT — President Joe Biden received his own Pfizer booster Monday afternoon, continuing his tradition of getting his Covid vaccines in public. He used the photo opp to urge people to get their primary vaccine series if they haven’t. “Boosters are important, but the most important thing we need to do is get more people vaccinated,” Biden said. He also likely made Moderna and J&J recipients cringe when he said boosters for those vaccines “will come later, maybe, I assume.”

Not to be outdone: Senate Minority Leader Mitch McConnell, a polio survivor, announced he, too, got his booster dose Monday.

MARKS TAKES COMMAND OVER VACCINE REVIEW OFFICE — FDA Center for Biologics Evaluation and Research Director Peter Marks announced in a memo to agency staff Monday that he has formally assumed the responsibilities of departing director of the Office of Vaccines Research and Review Marion Gruber.

The decision by Marks to step in as the office’s acting director comes at a critical time for FDA; the agency is expected to adjudicate in the near future if boosters are needed for people who received Moderna and J&J Covid-19 vaccines.

“During the next days and weeks, I will be working very closely with the OVRR team to ensure that the important public health work of the organization continues to move forward,” Marks wrote.

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Drug Pricing

DEMS VOICE WILLINGNESS TO SLIM DOWN HEALTH CARE PROPOSALS — Top House Democrats are voicing a new willingness to pare down their ambitious health care proposals within the sweeping $3.5 trillion social spending bill as they scramble to build consensus ahead of a potential vote this week, POLITICO’s Alice Miranda Ollstein reports. The ongoing debate underscores the massive challenge Democratic leadership faces as Speaker Nancy Pelosi announced plans for a vote this week on both the bipartisan infrastructure bill and the reconciliation package.

Some of the cuts under discussion include:

— Slashing President Biden’s call for $400 billion to boost long-term care services in half, with lawmakers pushing for enough funding to clear the more than 800,000 person waitlist of people in line for home health services under Medicaid.
— Expanding Medicaid to more than 2 million people in red holdout states for five years instead of permanently.

Eye on FDA

CDRH LEADERSHIP HOLDS TOWN HALL AT ADVAMED CONFERENCE — FDA medical device chief Jeff Shuren took to AdvaMed’s annual conference Monday to sell the industry on the agency’s performance under MDUFA IV and pitch companies on supporting new programs FDA wants implemented in the next iteration of user fees.

“We all know we're in the midst of reauthorization discussions, we have continued to make good on commitments under MDUFA, obviously, a few setbacks with Covid,” Shuren said during his presentation. “But I do want to flag that even as we get past COVID, there will be challenges for us to make good on some of the goals that we had set out before us in part due to a higher than expected workload coming in the door.”

AdvaMed’s Janet Trunzo moderated the panel, which included a who’s who of FDA’s medical device center, including Shuren, Tammy Beckham, Matthew Diamond, Malvina Eydelman, Douglas Kelly, William Maisel, Daniel Montgomery, Edward Margerrison, Suzanne Schwartz, Tim Stenzel, Michelle Tarver and Eli Tomar.

STENZEL: FDA STANDARDS FOR RAPID TESTS ARE DEFENSIBLE — FDA’s current expectations for the validation of antigen tests are “a solid, defensible position,” Stenzel told attendees of the MedTech Conference Monday. The remarks come amid a renewed wave of demand for limited supplies of the popular rapid at-home Covid-19 tests and public pressure on FDA to take a more lenient regulatory stance toward the products.

“It's important that patients and clinicians can rely on accurate results,” Stenzel said. “And we have seen some tests either be very insensitive or very nonspecific. And either of those scenarios can present significant challenges or challenges to the interpretation and use of that data.”

FDA LAYS OUT NEXT STEPS FOR SUNSCREEN REGULATION — FDA on Friday proposed a new framework for regulating over-the-counter sunscreens that allows SPF values up to 80, adds new labeling requirements and lays out which active ingredients are generally recognized as safe and effective.

The details in the proposed order are “substantively the same” as FDA’s 2019 proposed rule on sunscreens, according to the agency. In the short term, the agency posted a deemed final order which “essentially preserves the pre-[Coronavirus Aid, Relief, and Economic Security Act] status quo” for sunscreens.

A message from the Partnership for America’s Health Care Future:

MEDICAL DEVICES

FDA REVIEWING LEFT ATRIAL APPENDAGE OCCLUSION JAMA STUDY — FDA told health care providers Monday it is evaluating a recent study published in JAMA Cardiology that found women have worse outcomes than men when treated with a left atrial appendage occlusion medical device.

“The FDA will work with the manufacturers of approved LAAO devices to evaluate information from several sources, including premarket studies, mandated postmarked studies, and real-world data to provide additional information on this issue,” Kaveeta Vasisht, director of FDA’s Office of Women’s Health, wrote in an email. “Currently, the FDA believes the benefits continue to outweigh the risks for approved LAAO devices when used in accordance with their instructions for use.”

Around the Agencies

PHARMACIST PLEADS GUILTY TO FEDERAL CHARGE OF VACCINATING YOUNG CHILDREN — On Friday, Liz Ann Banchs, the owner and president of Farmacia Gabriela, Inc., in San Juan, Puerto Rico, pleaded guilty to the federal charge of vaccinating 24 7- to 11-year-olds with full doses of the Pfizer-BioNTech vaccine, the District of Puerto Rico’s District Attorney announced . These vaccinations didn’t lead to any serious adverse events, but FDA hasn’t granted the Pfizer-BioNTech vaccine emergency use authorization for children under 12. Last week, Pfizer-BioNTech released preliminary data showing their vaccine was safe and effective in children aged 5 to 11.

USTR DELAYS TARIFF INCREASE ON CHINESE MEDICAL GOODS FOR 45 DAYS — The Biden administration said Monday it will delay plans to raise tariffs on Chinese-made medical goods needed in the fight against Covid-19, POLITICO’s Doug Palmer reports. The move came after the American Hospital Association urged U.S. Trade Representative Katherine Tai in a letter not to raise tariffs on those products. "We urge you to extend the exemptions to ensure hospitals and health systems have the supplies they need so they can continue to provide safe and effective care to all patients," Ashley Thompson, AHA's senior vice president for public policy analysis and development, wrote. "These exemptions have been critical to these efforts."

Industry Intel

EISAI AND BIOGEN BEGIN SUBMITTING NEW ALZHEIMER’S DRUG FOR FDA APPROVAL — On Monday, Eisai announced it had begun the rolling submission for lecanemab, an antibody therapy it makes with Biogen, for FDA approval. The therapy is being submitted under the FDA’s accelerated approval process — the same one as the controversial therapy Aduhelm — based on data from a Phase IIb trial that it was safe and decreased target proteins in the brains of participants with early Alzheimer’s disease.

PFIZER COMMENCES LATE-STAGE CLINICAL TRIALS FOR COVID ANTIVIRAL THERAPY — On Monday, Pfizer announced it had begun a Phase II/III clinical trial for a prophylactic antiviral pill to prevent individuals from developing Covid-19. In the trial, Pfizer’s new antiviral will be given in combination with another antiviral to healthy adult participants who live with a confirmed Covid-19 patient. The goal is to potentially prevent symptomatic disease — and possibly further transmission — in people who have been exposed to the disease, Mikael Dolsten, Pfizer’s chief scientific officer and president of worldwide research, development and medical.

... and it can’t let Moderna have all the mRNA fun: The company also announced on Monday had begun a Phase I clinical trial for an mRNA-based flu vaccine. Moderna started a Phase I/II trial for its flu vaccine in July.

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Pharma Worldwide

BIDEN NOMINATES AFRICA CDC BOSS TO LEAD PEPFAR — Biden announced Monday he intends to nominate John N. Nkengasong as the ambassador-at-large and coordinator of the U.S. government’s efforts to combat HIV/AIDS globally, POLITICO’s Carmen Paun reports. The virologist with U.S. citizenship is the first African nominated to fill the position. If confirmed by the Senate, he would permanently fill the position after an 18-month gap, during which its former head Deborah Birx became the White House coronavirus response coordinator.

Pharma Moves

William Fleming, president of Pharmacy Solutions and chief corporate affairs officer at Humana, is the new chairman of the Pharmaceutical Care Management Association’s board of directors. Paul Marchetti, president of IngenioRx, has also joined the board.

Inside AgencyIQ

Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA.

New viral variant test requirements from FDA – Late last week the FDA’s Center for Devices and Radiological Health (CDRH) announced that manufacturers of tests with Emergency Use Authorization (EUA) will need to assess on an ongoing basis whether emerging viral variants of SARS-CoV-2 affect device performance. Previously, while the agency expected developers to monitor whether their product was "impacted" (i.e., a 5% drop in performance, or performance below the authorization baselines), the FDA did not include the requirement to do so a condition of authorization for all tests. However, last week the FDA amended nearly all existing EUAs to include this condition to require ongoing tracking. Companies now have three months to update their labeling, including a disclaimer that “clinical performance has not been established with all circulating variants” and that the test’s performance “may vary” based on what variants are circulating.

Quick Hits

Henry Walke, the CDC veteran who’s overseen the agency’s Covid response for more than a year, will hand over that role to Barbara Mahon, deputy chief of CDC’s enteric disease branch, POLITICO’s Erin Banco and Sarah Owermohle report. The shuffle comes as burnout and fatigue course through the agency after nearly two years of fighting the pandemic.

Document Drawer

CMS posted a final national coverage determination for home use of oxygen to treat cluster headaches.

FDA announced Monday it is holding a virtual public workshop on October 13 and 14 to discuss current science and challenges in the development of drug treatments for acute pain in children less than 2 years old.

A message from the Partnership for America’s Health Care Future:

Government-controlled health insurance systems - like the public option and Medicare at 60 - could increase costs for patients and threaten access to the quality care Americans rely on.

Lawmakers should build on and improve what’s working in health care where private coverage, Medicare and Medicaid work together, not start over by creating unaffordable, new government health insurance systems. Get the facts.