What happens with a monkeypox emergency

From: POLITICO Pulse - Friday Aug 05,2022 02:01 pm
Presented by PhRMA: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy.
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By Sarah Owermohle and Krista Mahr

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PhRMA

WELCOME TO FRIDAY PULSE and, sadly, the last issue penned by your co-author Sarah Owermohle. I’ve had a great four-year run at POLITICO and the best time writing Pulse, but this newsletter will be in very good hands without me. Keep sending Krista news and updates at kmahr@politico.com and feel free to say hi sometime at sarah.owermohle@protonmail.com .

 

A message from PhRMA:

Democrats’ misguided drug pricing bill would threaten at least 100 new cures and treatments in the coming decades. And that’s just the beginning. As Rep. Peter Welch said, “They know if we get price negotiation, it’s the beginning, it’s not the end.” That slippery slope might be ok with Democrats, but it’s bad for patients.

 
Driving the Day

A sign urges the release of the monkeypox vaccine

The monkeypox public health emergency declaration comes amid growing calls for more vaccines. | Haven Daley/AP Photo

WHAT A MONKEYPOX PHE MEANS — The Biden administration’s expected public health emergency declaration for monkeypox landed Thursday as case numbers continue climbing and health officials admit they may not even have the full picture of its spread.

“We’re prepared to take our response to the next level in addressing this virus,” HHS Secretary Xavier Becerra told reporters in a call that included Assistant Secretary for Preparedness and Response Dawn O’Connell, CDC Director Rochelle Walensky, FDA Commissioner Robert Califf and Robert Fenton and Demetre Daskalakis, who were recently tapped to head the White House’s monkeypox response.

The declaration comes as more than 6,600 monkeypox infections have been reported in the United States, with more than 1,200 cases reported in the last three days.

What happens now: A public health emergency lets federal health officials make decisions more quickly about dispatching vaccines and treatments, accumulating data and moving money for the response. It’ll also be the first test of the Biden administration’s recent decision to elevate the preparedness and response office to an independent department on par with the FDA and the CDC.

But at the top level, officials hope that the emergency declaration will show they’re serious about combating a virus that’s mostly affected those in the LGBTQ community, raising concerns that people who test positive could be stigmatized.

“I look at it as a very important symbolic expression of how seriously we take what is happening right now,” President Joe Biden’s chief medical adviser Anthony Fauci told Reuters in an Instagram Live interview minutes before the announcement. Fauci also stressed that cases are likely undercounted but swerved questions on whether the vaccines would be offered widely.

“The goal has always been to vaccinate as many people as possible,” Califf told reporters. “We’re considering an approach for the current doses of Jynneos that would allow health care providers to use an existing one-dose vial of the vaccine to administer a total of up to five separate doses.”

Sen. Kyrsten Sinema speaks during a Senate Homeland Security and Governmental Affairs Committee confirmation hearing.

Sinema's support would secure a needed vote for a long-negotiated reconciliation package. | Al Drago/Bloomberg

 

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DEMOCRATS SET UP FOR WEEKEND VOTESenate Democrats will try to advance their signature climate, tax and health care proposal on Saturday, Majority Leader Chuck Schumer said — a significant commitment as some of the bill’s specifics are still clouded in uncertainty, Burgess Everett and Marianne Levine write.

The timeline: Schumer and other party leaders set out today to resolve outstanding issues but had a late-night Thursday win with Arizona’s Kyrsten Sinema signaling support.

The legislation negotiated between Schumer and West Virginia Democrat Joe Manchin would extend Obamacare subsidies through 2024, direct Medicare to negotiate lower prices for prescription drugs, send money toward the deficit and set up climate change measures.

There’s also a slew of amendments to work through, a vote-a-rama is “going to start later than we imagine, it’s going to run longer than we would hope and it’s going to be more painful getting out of here than any of us have any reason to expect,” said Sen. Chris Coons (D-Del.).

PHRMA ISSUES WARNING — The trade group is pressing Democrats to vote against the reconciliation package because of its sweeping drug pricing reforms.

“Regardless of the outcome in the coming weeks, this fight isn’t over,” PhRMA President Steve Ubl said in an interview with Megan Wilson. “Few associations have all the tools of modern political advocacy at their disposal in the way that PhRMA does.”

PhRMA’s board sent a letter to every member of Congress Thursday afternoon, urging them to vote against the package because of a measure that would let Medicare negotiate the price for certain costly medicines.

Ubl hinted that the lobby could run campaign ads against Democrats who vote for the measure but declined to talk legal strategies “for fear that tipping our hand would foreclose future options” — or what changes could come from future regulations or legislation.

The stakes are high for the drug industry: Allowing Medicare to negotiate the cost of high-price drugs is expected to save the federal government more than $100 billion. The move would “put the U.S. system on a course toward broad government control, setting the stage for our country to fall behind,” reads the letter sent to Congress on Thursday.

 

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CLINTON FDA HEAD TO LEAD EXTERNAL REVIEW — Jane Henney, a former FDA commissioner, has been tapped by the Reagan-Udall Foundation to lead an FDA-requested external review of key agency offices on human food safety and tobacco regulation, two sources with knowledge of the matter told our colleagues Katherine Ellen Foley and Adam Cancryn.

Henney’s appointment hasn’t been formally announced, but she would oversee the reviews of each regulatory area and the relevant parts of the Office of Regulatory Affairs, which conducts inspections. Reagan-Udall said the review will result in two separate reports delivered to the agency 60 business days after the project launches.

However, former agency and regulatory experts are skeptical about whether this review will lead to meaningful change at the agency, partly due to Reagan-Udall’s ties with the FDA and industry.

“I expect that they’ll give some kind of low-hanging fruit recommendations,” said one former senior FDA official, who was granted anonymity to speak candidly on the matter.

“Reagan-Udall will be aligned with Califf,” another former senior FDA official familiar with the matter said. “This is an attempt to give him [Califf] some breathing room to let him make some decisions on how he’s going to organize these offices moving forward.”

Ellen Sigal, chair of the foundation’s board of directors, defended the move. “This study is exactly what Reagan-Udall was established to do.”

Health Costs

POLL: AMERICANS ARE SKIMPING ON CARE BECAUSE OF COSTS — Nearly 40 percent of American adults say they recently skipped or delayed health care treatments because of high costs, according to a poll by West Health and Gallup .

Women are disproportionately cutting back compared with men, especially younger women. Thirty percent of women — and 36 percent of women under 50 — reported doing so compared with 22 percent of men.

Economic disparities are worsening the divide. People cutting back on utilities, food, driving and other expenses were also far more likely to report delaying health care services. Women and Black adults were also more likely to say they’re concerned about health care costs than other respondents.

More than four in 10 Republicans said they were concerned or “extremely concerned” about costs compared with 33 percent of Democrats and 42 percent of independents. But across party lines, respondents said they have little confidence in their elected representatives to solve the problems.

Around the Nation

DESANTIS SUSPENDS STATE ATTORNEY RESISTING ABORTION LAW — Florida Gov. Ron DeSantis on Thursday suspended a Tampa-area elected state attorney who recently became the only prosecutor in Florida to sign a pledge that he would not prosecute people under the state’s newly enacted abortion law.

The suspension of 13th Judicial Circuit State Attorney Andrew Warren is effective immediately and comes as he has not only taken outspoken stances on Florida’s newest abortion law but was seen as a rising figure in Florida Democratic circles, POLITICO’s Matt Dixon reports.

DeSantis said his decision was made because Warren was picking and choosing which laws to enforce. The governor raised Warren’s objection to prosecuting people under Florida’s newly enacted 15-week abortion ban, which doesn’t provide exceptions for rape and incest, as well as Warren signaling he supported gender-affirming treatments for trans minors, which DeSantis has condemned.

NJ UNIONS USE COVID FUNDS FOR PREMIUM HIKES — Some of the state’s top union leaders are requesting that public employees’ health care contributions be frozen at current levels and federal Covid relief funds be used to help offset proposed rate increases for those workers’ health insurance.

In a letter to Gov. Phil Murphy obtained by POLITICO’s Daniel Han, the leaders of the New Jersey State AFL-CIO, Communications Workers of America, New Jersey State Policemen's Benevolent Association and other public employee unions said the steep proposed rate increases to the State Health Benefits Program would “cause a financial crisis for New Jersey workers, the public and State and local governments.”

The union leaders also criticized top officials from the Department of Treasury, which oversees the public employee health insurance program, and Horizon Blue Cross Blue Shield of New Jersey, which administers the health insurance plans.

 

A message from PhRMA:

Democrats’ drug pricing bill would threaten at least 100 new cures and treatments in the coming decades. That’s just the beginning. As Rep. Peter Welch said, “They know if we get price negotiation, it’s the beginning, it’s not the end.” And the WSJ editorial board agrees: “The slippery slope [of price setting]… will get slipperier, & American drug innovation will be the poorer for it.”

 
What We're Reading

In some ways, the 30-year-old billionaire Sam Bankman-Fried is a reluctant Democratic donor. But he’s reshaping political contributions partly to make pandemic preparedness and health care top goals, POLITICO’s Elena Schneider writes .

A West Virginia man was sentenced to three years in federal prison after sending threatening emails to Fauci and former National Institutes of Health Director Francis Collins, AP News reports .

In West Texas, where women are already struggling to find quality pregnancy care, maternal health wards are shutting down and nursing shortages are leaving providers hobbled, Bloomberg’s Claire Suddath reports .

 

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