White House keeps Covid messaging simple — Delta accounts for most U.S. cases — Onshore drug manufacturing could take a regulatory overhaul

From: POLITICO Pulse - Wednesday Jul 07,2021 02:06 pm
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By Adam Cancryn and Sarah Owermohle

With Katherine Ellen Foley, David Lim and Daniel Lippman

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Quick Fix

— The White House is increasingly focusing its Covid-19 response on the minority of unvaccinated Americans driving new infections.

— The more transmissible Delta variant of Covid-19 now makes up most cases in the U.S.

— Biden’s desire to jumpstart U.S. drug manufacturing could take billions of dollars and a regulatory overhaul.

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Driving the Day

THE WHITE HOUSE KEEPS IT SIMPLE ON COVID — Coronavirus cases are falling across much of the U.S. — except in the pockets where they’re rising sharply. The vaccination campaign is making headway, but at a far slower and more arduous pace. And as the Delta variant spreads, new reports of breakthrough infections overseas have suddenly dampened the July Fourth mood.

Yet, if the pandemic is getting more complicated, the White House’s perspective is only getting simpler: “If you’re vaccinated, you’re protected. But if you’re unvaccinated, you’re not,” President Joe Biden said Monday.

That straightforward message is fast becoming the White House’s new Covid mantra — and one that reflects a narrowing of the federal response to focus almost exclusively on the 30 percent or so who remain unvaccinated.

After months of mass appeals and pricey education campaigns, nearly everyone who wants a shot has gotten one. What remains is a single, difficult task: Changing as many resistant Americans’ minds as possible.

The administration has vowed to throw everything at that goal, and Biden on Monday highlighted a range of additional outreach initiatives. But he also alluded to the reality that any progress from here on out will be halting and difficult, with no total victory any time soon.

“We need to go community by community, neighborhood by neighborhood, and oftentimes door to door,” Biden said. “We can’t get complacent now.”

DELTA VARIANT DRIVING US COVID CASES — The more transmissible Covid-19 strain accounted for more than half of all cases between June 20 and July 3, according to new data from the CDC.

That represents an increase from just 30.4 percent in the two-week period ending June 19, POLITICO’s David Lim and Erin Banco report — raising questions about how the administration will contain the variant on a national level. In states such as Iowa, Kansas and Missouri, CDC projections indicate the Delta strain represented more than 80 percent of cases during that time.

The spread has added fresh urgency to the vaccination effort, with Biden officials warning that unvaccinated communities are increasingly vulnerable to outbreaks. Still, the administration isn’t considering precautions like new recommendations on mask wearing — opting instead to redouble efforts to get more people vaccinated.

The White House is also downplaying the threat to vaccinated individuals. On Monday, press secretary Jen Psaki dismissed early research from Israel indicating the Pfizer vaccine was less effective against the Delta variant as “preliminary.”

“The vast majority of data from larger assessments and larger studies shows that it is quite effective,” she said.

BIDEN FACES BARRIERS TO BRINGING DRUGMAKING BACK ONSHOREBiden wants more essential drugs to be made in the U.S. But it's not clear if there's enough political will, or money, in Congress to make that happen, Katherine Ellen Foley writes.

The problem: Regulatory and industry experts have known for years that the drug supply chain is fragile and opaque, but the Covid-19 pandemic put these problems in the public spotlight. For example,: 29 of 40 critical drugs for treating Covid-19 patients were in shortage at various points in 2020, including common pain relievers and sedatives used for people on ventilators.

The White House last month announced plans to boost domestic production of anywhere from 50 to 100 generic drugs through public-private partnerships. Congress also channeled $60 million to HHS in the last relief package to jumpstart efforts.

But the goal is likely to take billions — plus regulatory overhauls, reimbursement changes and research investments, Katherine writes. So despite bipartisan congressional support for onshore manufacturing, some lawmakers could balk at more spending.

“[Republicans] are getting spending fatigue,” a Democratic Senate staffer said. “They have a feeling of 'well we've invested through the American Rescue Plan,’” and that’s enough, the aide said, referring to the $1.9 trillion coronavirus relief package enacted in March.

 

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SHAKY ROLLOUT FOR VA’S HEALTH RECORDS SYSTEM — The Department of Veterans Affairs’ pricey digital health record overhaul created confusion and technical difficulties during a rollout in Washington state, according to a preliminary review obtained by POLITICO’s Darius Tahir.

The draft report found that the system made it harder for veterans to refill prescriptions and hurt providers’ productivity, with management unable to review its performance. Those issues could make it more difficult for the government to justify the continued deployment of a system projected to cost at least $16 billion over a decade.

The silver lining: The problems didn’t result in any patients being harmed, the report concluded.

But it’s still likely to ramp up scrutiny of the records revamp on Capitol Hill and in the administration — where VA Secretary Denis McDonough has not yet laid out plans for the program’s future.

CMS SETTLES ON A MEDICARE CHIEF Meena Seshamani will run CMS’ Center for Medicare, putting her in charge of the office responsible for policies affecting more than 61 million older adults and other Americans.

An Obama-era HHS alum, Seshamani was director of the Office for Health Reform that managed early implementation of the Affordable Care Act. She’s spent the last four years at MedStar Health, most recently as its vice president of clinical care transformation.

It’s the latest high-level appointment at CMS. Seshamani’s hiring comes a week after it named Daniel Tsai to run the Medicaid office. Erin Richardson, the agency’s chief of staff, came on board earlier in June.

The FDA's drug center is also adding to its top ranks. Jacqueline Corrigan-Curay will be the principal deputy center director for the agency's Center for Drug Evaluation and Research, under Director Patrizia Cavazzoni.

Corrigan-Curay previously led the FDA's Office of Medical Policy. M. Khair ElZarrad will now serve as that office's acting director.

In Congress

SENATE PANEL TURNS TO PHARMACEUTICAL ANTITRUST The Judiciary Subcommittee on Competition Policy, Antitrust and Consumer Rights will put the drug industry in the hot seat with a Tuesday hearing titled “Cracking Down on Anticompetitive Conduct in Prescription Drug Markets.”

Senators will question high drug pricing and tactics like “pay-for-delay” that stall competition, an aide said. They will also discuss how broad antitrust reform or targeted approaches could help. Subcommittee Chair Amy Klobuchar (D-Minn.) and ranking member Mike Lee (R-Utah) signaled their plan to question the pharmaceutical industry in May.

Around the World

WHO BACKS COVID-19 THERAPIES, SPARKING COST COMPLAINTS — The World Health Organization on Tuesday endorsed using two different monoclonal antibodies — Roche’s Actemra, or tocilizumab, and Regeneron’s Kevzara, or sarilumab — for treating Covid-19 infections, opening the door for global use alongside the cheap steroid dexamethasone. But their call also triggered cost concerns as advocates pointed to the high price of Roche’s medicine in particular.

“Roche must stop following a business-as-usual approach and take urgent steps to make this drug accessible and affordable for everyone who needs it by reducing the price and transferring the technology, know-how, and cell lines to other manufacturers,” said Julien Potet, a policy advisor for Médecins Sans Frontières’ Access Campaign.

Why Actemra matters: Its price ranges from $3,625 in the U.S. to $646 in India, making it pricey on a large scale. An MSF spokesperson said that access to both treatments is key, and Actemra in particular “could be essential for treating people with critical and severe cases of COVID-19 if only the price of the medicine wasn't soh high.” The nonprofit also complained that Actemra has been on the market since 2009 to treat arthritis, and it’s its production cost is a fraction of the retail price.

NONPROFIT FUNDS VACCINE STUDY IN VULNERABLE PATIENTS — The Coalition for Epidemic Preparedness Innovations said Tuesday it will co-fund a Norwegian study of coronavirus vaccines’ efficacy in people who are immunosuppressed, including those who have received an organ transplant.

Why it matters: Data is limited on the vaccines’ effectiveness and safety for that vulnerable group, but there’s mounting concern they’ll need booster shots in the months ahead. Study leaders plan to offer a booster to participants in the vaccine arm who show little to no immune response to the usual regimen.

CEPI is providing $3.1 million while a consortium of Norwegian health groups is chipping in $3.6 million.

Names in the News

Jessica Daley is Premier Inc.’s new chief pharmacy officer. In addition to filling the newly created role, Daley will also be a supply chain group vice president for the health care company.

Roberto Jose Coquis is the director of operations at consulting firm Golden Key Group. Coquis was a Trump-era deputy assistant secretary at the Substance Abuse and Mental Health Services Administration.

 

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What We're Reading

The anti-parasitic drug ivermectin is the latest dubious Covid-19 “cure” to be embraced by fringe doctors and some media personalities, Vice’s Anna Merlan reports.

Once a high-profile e-cigarette company, Juul Labs is fighting for survival and trying to convince the FDA to let it continue selling its vaping products in the U.S., The New York Times’ Sheila Kaplan reports.

From people living near the border to asylum seekers stranded in transit or people deported from the U.S. to Mexico, border policies have shaped Covid-19 care for thousands and reverberated in the Covid-19 response, scientists and policy experts write in the latest issue of Health Affairs.

 

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