The legal fight over Biden’s vaccine order begins

From: POLITICO Pulse - Monday Nov 08,2021 03:02 pm
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Quick Fix

— The Biden administration's workplace vaccination requirement is on hold after a court temporarily halted its implementation.

— The U.S government helped Moderna develop a lucrative Covid-19 vaccine. But officials now say the company isn't doing its share to help end the pandemic around the world.

— The drug industry is still trying to reshape Democrats' plan to slash the cost of medicines.

WELCOME TO MONDAY PULSE — where an anxious nation can exhale; Big Bird is vaccinated . Still no word on Animal’s status. Send tips to acancryn@politico.com and sowermohle@politico.com.

 

A message from PhRMA:

At a time when the science has never been more promising, the Democrats’ latest drug pricing scheme puts patients in harm’s way by threatening future treatments and cures. Learn more.

 
Driving the Day

BIDEN’s VAX ORDER HITS A ROADBLOCK — The Biden administration spent weeks building the case for widespread Covid-19 vaccine requirements, orchestrating a careful rollout of rules aimed at expanding inoculations in workplaces and health care settings.

Then, within 48 hours of the regulations going public, everything got put on hold.

A federal court in Louisiana has temporarily blocked the federal vaccine-or-test mandate meant for private businesses, kicking off a legal fight that could determine the survival of President Joe Biden’s most aggressive vaccination effort to date, POLITICO’s Rebecca Rainey reports.

The panel of judges wrote over the weekend that the rules raise “grave statutory and constitutional issues” and gave the administration until 5 p.m. today to respond. GOP-led Texas, Louisiana, Mississippi, South Carolina and Utah are among the plaintiffs in the case, which was one of four lawsuits filed across the country in recent days.

What they’re arguing: The legal challenges hinge on whether the Labor Department has the authority to issue such a rule, and argue that it also didn’t follow the procedure in issuing the emergency regulations.

One lawsuit led by Florida, Georgia and Alabama also claims that the mandate – which requires millions of workers to get vaccinated or be tested weekly – conflicts with the First Amendment and the Religious Freedom Restoration Act.

The administration is standing its ground. Surgeon General Vivek Murthy was dispatched Sunday to defend the regulations, insisting on ABC’s “This Week” that there is longstanding precedent for its legality.

“The president and the administration wouldn’t have put these requirements in place if they didn’t think they were appropriate and necessary,” Murthy said. “And the administration is certainly prepared to defend them.”

He cited prior vaccine mandates put in place in schools, hospitals and the military dating to George Washington, who required that troops get vaccinated against smallpox.

TODAY: JILL BIDEN TOUTS COVID VACCINES FOR KIDS — The first lady is visiting a pediatric Covid-19 vaccination clinic at a McLean, Va., elementary school this afternoon, marking the start of a nationwide campaign to get children aged 5 to 11 vaccinated. Murthy will accompany her.

HHS Secretary Xavier Becerra and Education Secretary Miguel Cardona separately sent a letter to school superintendents and elementary school principals urging them to promote child vaccinations, including by setting up inoculation clinics at their schools.

HOW A TRUMP-ERA DEAL IS HAMPERING GLOBAL VAX EFFORTS — The federal government poured billions of dollars and years of research into helping Moderna develop its Covid-19 vaccine.

Yet while Moderna spent the last year reaping the financial rewards of the taxpayer-subsidized shot, the administration has struggled to convince the company to aid its own global vaccination campaign, your PULSE authors and Erin Banco report.

The biotech firm instead brokered sales worth billions of dollars to wealthy nations, devoting the majority of its limited vaccine supply to the places that can afford to pay a premium. The strategy is set to generate as much as $18 billion for the once-tiny outfit this year, and has personally made Moderna’s CEO a multibillionaire.

But the approach has also left the developing world behind. Moderna has refused to share its vaccine formula with manufacturers serving low-income countries and resisted pleas to ramp up direct aid to the neediest countries. When a WHO-backed manufacturing hub in South Africa approached Moderna about partnering to accelerate production, the company refused – and later said it would build its own facility, even though the construction could take years.

In private conversations with Moderna representatives, current and former administration officials said they felt the company has been disdainful of the idea it should serve as a global supplier.

Moderna’s reluctance to supply doses at a discount has soured its once-close relationship with the government, and raised the ire of global health advocates who say the company has a greater responsibility to help Biden’s global vaccine campaign because of what it owes to U.S. taxpayers.

The White House has little recourse, though . The Trump-era contract the government signed with Moderna gave the company full control over the critical technology needed to replicate the vaccine. It also protected Moderna from being compelled by the administration to hand over its vaccine formula.

And for a period, the government was even prevented from donating its excess doses to foreign countries – a restriction that slowed the global response and allowed Moderna to negotiate its own international deals.

“The U.S. made a deal that was extraordinarily beneficial to Moderna and also beneficial to the United States,” said Lawrence Gostin, a global health law professor at Georgetown. “But it negotiated a horrific deal for the world.”

 

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Drug Pricing

THE NEVER-ENDING BATTLE OVER DEMS’ DRUG PRICE DEALDemocrats’ decision to wait for a budget score on their social spending bill is giving interest groups an opening for some last-minute lobbying – and the drug industry is taking full advantage.

The latest bid to reshape the party’s planned drug price overhaul is coming from generic drug and biosimilar manufacturers, POLITICO’s Megan R. Wilson reports. Those industries argue that the current deal incentivizes brand-name drugmakers to negotiate lower prices with the government – thereby crowding generics and biosimilars out of the market.

The 11-year exclusivity period complex-molecule drugs would receive before negotiations can begin also creates uncertainty for biosimilar drugs that are expensive and can take upwards of a decade to develop, the biosimilars lobby contends.

The industry also objects to language penalizing drug makers that raise the cost of medicines faster than the rate of inflation.

The proposed fix: Generics and biosimilar manufacturers want to create a carve-out exempting drugs from price negotiation if there’s a generic or biosimilar competitor that could soon come to market.

They’re also pushing for an exemption for generic drugs from the penalty for steep price hikes -- a provision that was included in a previous drug pricing proposal from Sens. Ron Wyden and Chuck Grassley.

 

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KLAIN: VOTERS WANT MORE PROGRESS — The White House is keeping the pressure on Congress to quickly pass the $1.75 trillion bill, with chief of staff Ron Klain tying last week’s electoral setbacks to voters’ need to “see more action in Washington.”

Klain on Sunday expressed confidence that Democrats would eventually get the spending package to Biden’s desk, albeit not before the Senate makes changes to the version that the House sends over.

A group of centrist holdouts in the House have committed to providing the support needed to advance the bill assuming the CBO gives it a satisfactory CBO score – though it could still take days to get to that point, and Sen. Joe Manchin has already voiced reservations with some of the legislation’s key elements.

For your reference: POLITICO’s policy reporters are tracking all the developments around the bill’s tension points here, including on drug pricing, paid leave and Medicare and Medicaid reforms.

 

BECOME A GLOBAL INSIDER: The world is more connected than ever. It has never been more essential to identify, unpack and analyze important news, trends and decisions shaping our future — and we’ve got you covered! Every Monday, Wednesday and Friday, Global Insider author Ryan Heath navigates the global news maze and connects you to power players and events changing our world. Don’t miss out on this influential global community. Subscribe now.

 
 
Coronavirus

ICYMI: PROMISING RESULTS FOR PFIZER’s COVID PILLThe antiviral pill developed by Pfizer cuts hospitalization and death from Covid-19 by as much as 89 percent, the company announced, results that are strong enough to justify submitting the drug for FDA review as soon as possible.

The data came from an interim analysis of Pfizer’s Phase II/III trial of high-risk adults with Covid-19 who were treated within three days of showing symptoms, Sarah writes. If authorized, the pill could become a critical part of combating the virus and curbing severe illness – especially because the drug is easier to manufacture and distribute than other available therapies.

Pfizer would be the second company to seek authorization for a Covid-19 antiviral drug. Merck previously applied for emergency-use authorization for its pill, molnupiravir.

Names in the News

Madeleine Russak is the new communications director for Sen. Mazie Hirono. She was previously the deputy communications director for the Senate HELP Committee.

Lydia Orth is now the director of Medicaid initiatives at Families USA. She previously worked at the Office of Management and Budget and is an alum of CMS’ Medicare-Medicaid Coordination office.

Mark W. Murphy is now EVP and chief information and digital officer at 3M. He most recently was VP and CIO for business and technology services at Abbott Laboratories.

What We're Reading

In STAT, Sudhakar Nuti writes about how pandemic burnout has changed him as both a doctor and a person.

A new Los Angeles ordinance requiring proof of vaccination to dine indoors has restaurant owners in low-vaccination areas worried people will simply stop showing up , The Los Angeles Times’ Jenn Harris writes.

The Washington Post’s Eli Saslow reports on how a vaccination mandate divided the staff at a rural Washington state hospital.

 

A message from PhRMA:

The Democrats’ hyper-partisan drug pricing plan is a detriment to patients and the future of medical research.

The plan guts the very incentives necessary to encourage investment in further research and development after medicines are approved, giving the government the power to pick winners and losers for lifesaving medicines.

While some would have you believe this is “negotiation,” it isn’t. It’s government price setting that does little to address patient affordability and will decimate the competitive ecosystem in the United States that has brought hope to so many Americans in the form of new medical advances where before there were none. No matter what they call it, this plan will result in the same outcome: negative consequences for the patients with the most need. Read more.

 
 

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