With Daniel Lippman

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Quick Fix

— The FDA's decision to approve an Alzheimer's drug despite little proof of its effectiveness is stoking concern about the agency's lack of a permanent commissioner.

— European leaders are still skeptical of the U.S.' global vaccination plans, as President Joe Biden will find during the G-7 summit.

— An FDA vaccine advisory panel is taking a deeper look into the safety and efficacy of Covid-19 vaccines for young children.

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Driving the Day

BIDEN’s FDA DILEMMA DEEPENS — Capitol Hill opposition to acting FDA Commissioner Janet Woodcock’s candidacy for the permanent job is hardening in the wake of the agency’s approval of a new Alzheimer’s drug known as aducanumab, your hosts report with Lauren Gardner.

The decision has outraged health experts, who point to the thin evidence for the drug’s effectiveness and its whopping $56,000-a-year price tag; already, three members of the FDA’s expert advisory panel have resigned in protest. And it has furthered suspicions among some Democrats that Woodcock remains too close to the industry that, as FDA’s acting head, she’s supposed to regulate.

On Thursday, Sen. Catherine Cortez Masto (D-Nev.) declared that she didn’t trust Woodcock’s judgment and wouldn’t back her to run the FDA permanently. Fellow Democratic Sen. Ed Markey of Massachusetts said he had “deep reservations” about her, and Sen. Elizabeth Warren of Massachusetts said she’d want to “see who else” is in the running before supporting Woodcock.

A handful of others — chief among them swing-vote Sen. Joe Manchin (D-W.Va.) — had previously harbored concerns over Woodcock’s track record on regulating opioids.

The White House has left the permanent FDA chief position open for nearly six months. Woodcock is still seen as a top contender who has the backing of several former commissioners and could earn enough Republican votes to win confirmation. Biden too was personally pleased with the Alzheimer’s drug approval, two people familiar said.

The administration has also found few viable alternative candidates. While Obama-era FDA official Michelle McMurry-Heath was vetted for the job, her current role as head of drug industry group BIO presents its own issues.

Still, tapping Woodcock now risks antagonizing a growing contingent of Senate Democrats at a time when Biden is trying to marshal support for his ambitious first-year agenda. “They don’t need Democrats to vote,” National Institute for Health Research President Diana Zuckerman said, “they just need Democrats not to be really angry.”

BIDEN SELLS THE WORLD ON HIS VACCINE STRATEGY — The president is touting his pledged 500 million-dose donation of Pfizer coronavirus shots as proof that the U.S. is resuming its role as a world leader ahead of days of meetings with the heads of other G-7 nations, POLITICO’s Nick Niedzwiadek writes.

Biden in a Thursday speech called the deal “a monumental commitment by the American people” — and drew a not-so-subtle contrast to China and Russia by emphasizing the donations will come with “no strings attached.”

But that won’t be enough to instantly repair relations. Belgium’s prime minister accused the U.S. of disrupting global vaccine production by invoking the Defense Production Act, telling POLITICO’s Ryan Heath that the “idea that you could always count on the United States … is gone.” Biden’s pledge will also mean U.S. manufacturers will continue to suck up precious raw materials also needed by the rest of the world.

In France, diplomats are miffed that the U.S. has yet to open up to fully vaccinated European travelers — even as Europe begins to welcome Americans. And in a dispatch from the U.K., POLITICO’s David Herszenhorn reports that other European leaders are already casting Biden’s recent vaccine announcements as an attempt to play catch-up.

European Commissioner President Ursula von der Leyen on Thursday alluded to the E.U.’s success at vaccinating millions of its own residents “whilst never stopping export.” Charles Michel, the European Council president, followed by declaring the E.U. “at the forefront of ensuring global equitable access to vaccines” and the largest exporter of doses to the world.

The U.K., meanwhile, pledged late Thursday to donate 100 million doses to other countries within the next year — part of an anticipated effort by the G-7 summit’s leaders to collectively provide at least 1 billion vaccines to the rest of the world.

Vaccines

WHAT VACCINE EXPERTS WANT TO KNOW ABOUT COVID SHOTS FOR KIDS — The FDA’s vaccine advisory panel focused much of its Thursday meeting on the safety of Covid-19 vaccines for young children, amid signs their developing immune systems can react differently to the shots than those of adults, POLITICO’s Lauren Gardner and Katherine Ellen Foley reports.

One example: While kids are less likely to develop severe Covid-19, some have been affected by a serious inflammatory syndrome called MIS-C that adults do not develop. CDC data show more than 300 minors have been hospitalized with MIS-C, with hospitalization rates higher among teens and those under 5 than kids ages 5 to 11.

That’s still a rare occurrence, given how widespread the coronavirus has become, but it’s prompting some advisory panel members to push for more extensive studies before authorizing more vaccines for emergency use in people under 18.

“The burden of disease is so small and the risks are just not clear,” said Cody Messner, a pediatrics professor at Tufts University School of Medicine.

Vaccine experts are also looking carefully at how FDA should measure vaccines’ efficacy in children, as well as the potential effects of administering them alongside other routine childhood shots, as the CDC has already recommended. Since kids are less prone to showing Covid-19 symptoms, it could take longer than normal to measure the shots’ efficacy using traditional methods.

Coronavirus

BIDEN MANDATING COVID SAFETY MEASURES FOR PROVIDERS — Hospitals and medical care providers must provide their workers with masks, maintain physical barriers and ensure proper ventilation under new rules imposed by the Labor Department, POLITICO’s Rebecca Rainey reports.

The regulations cover much of the health care industry: hospitals, nursing homes and assisted living facilities, as well as emergency responders and home health care workers. They also require employers to give workers paid time off to get vaccinated and recover from Covid vaccine side effects, a provision the White House hopes will help speed the immunization effort.

— But the rules are late and limited. The Labor Department missed its deadline by several weeks for deciding if mandatory work safety requirements were even necessary, as coronavirus cases fluctuated and the national vaccination effort ramped up.

The Labor Department then decided to narrow its focus to just the health care sector, instead issuing optional safety guidelines for all other workplaces, as well as specific guidance for protecting employees in riskier settings like meatpacking plants and grocery stores.

That pleased Republicans and business groups, which have opposed mandatory safety rules throughout. But it also brought a raft of criticism from unions and left-leaning organizations, with anti-poverty group Oxfam America calling it a “shameful failure of leadership.”

Names in the News

Kate Werley is now the legislative director for Rep. Mike Doyle (R-Pa.). She was previously Doyle's health policy adviser.

What We're Reading

In a New York Times essay, retiring CDC official Anne Schuchat reflects on her 33 years at the agency, and a pandemic that “left many among our ranks exhausted, threatened, saddened and sometimes sidelined.”

An Arizona man flew to India in April to be with his Covid-infected parents. He’s still trying to get back into the U.S., CNN’s Alisha Ebrahimji reports.

Seattle is the first major U.S. city to fully vaccinate 70 percent of its citizens ages 12 and older, the Seattle Post-Intelligencer’s Callie Craighead reports.

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