Inside Trump’s FDA pressure campaign

From: POLITICO Pulse - Thursday Aug 25,2022 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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Around the Agencies

President Donald Trump and White House trade adviser Peter Navarro

Peter Navarro (right), a former trade adviser under President Trump, stands by his belief that hydroxychloroquine is a valuable treatment for Covid-19. | Alex Brandon/AP Photo

TRUMP’S ATTEMPTED FDA SWAY — The Trump administration pressured the FDA to fast-track unproven Covid-19 treatments and vaccines, POLITICO’s Katherine Ellen Foley reports.

The former administration pushed for hydroxychloroquine to be reauthorized after data showed it was ineffective against Covid-19 and had side-effect risks, according to a report released Wednesday by Democrats on the House Select Subcommittee on the Coronavirus Crisis.

The White House also attempted to block the FDA from collecting additional safety data on Covid-19 vaccines, the report said, with the administration hoping to get the shots out before the 2020 election.

The attempts were previously reported by POLITICO and other outlets, though the report brings to light new details and documents that show how the administration pressured regulators.

The administration’s campaign to speed treatments and vaccines before the election even included pressuring former FDA Commissioner Stephen Hahn, whom Trump administration officials believed would be “weak” and “fold” under the pressure, according to new documents from the report.

Peter Navarro, a former trade adviser under Trump who worked on the administration’s coronavirus response, was a key figure in the report, as was Steven Hatfill, an adjunct virology professor at George Washington University and one of Navarro's advisers.

The report also revealed that Mehmet Oz, the celebrity physician and TV personality, promoted hydroxychloroquine to Trump officials and sought access to the drug for trials.

“The Select Subcommittee’s findings that Trump White House officials deliberately and repeatedly sought to bend FDA’s scientific work on coronavirus treatments and vaccines to the White House’s political will are yet another example of how the prior Administration prioritized politics over public health,” House Majority Whip Jim Clyburn (D-S.C.), who also chairs the subcommittee, said in a statement.

But Navarro doubled down on his push for hydroxychloroquine. In a statement to POLITICO, he said he believes it’s a valuable treatment and was justified in trying to influence the FDA.

"The partisan House Select Subcommittee report 'wrongly' perpetuates one of the most deadly lies of the pandemic, namely that the safe and powerful therapeutic to treat COVID, hydroxychloroquine, was somehow dangerous," he said.

 

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Insurance companies and PBMs don’t pay full price for insulin. So why do patients? Rebates, discounts and other payments from manufacturers lower the cost of insulins by more than 80% on average. But insurers and PBMs don’t usually share these discounts directly with patients. Congress should address the system we use to pay for medicines. Fix harmful insurance practices and lower out-of-pocket costs for patients. Stand up for patients.

 
Public Health

A page from the 2019 U.S. Medicare Handbook in Washington

The number of Medicare beneficiaries covered through Medicare Advantage is slowly, but significantly, rising. | Pablo Martinez Monsivais/AP Photo

THE SLOW RESHAPING OF MEDICARE — Most Medicare beneficiaries will soon get their coverage through Medicare Advantage, according to a new report from the Kaiser Family Foundation out this morning.

That shift could come as soon as next year, the report says, and represents the culmination of a slow move over several years. This year, 28.4 million in 58.6 million Medicare beneficiaries are enrolled in Medicare Advantage plans.

That number — nearly half of beneficiaries — shows significant growth since 2007, when about 20 percent of them were enrolled in Medicare Advantage plans.

PROVIDERS’ PANDEMIC PROBLEMSIn a new study from the Centers for Medicare and Medicaid, health care providers discussed their wins and losses through the pandemic. CMS hopes the study will help better prepare providers for the next public health emergency.

The study, conducted from May to September 2021, considered how the Covid-19 public health emergency affected providers during that period.

Researchers consulted 30 providers across 10 states. They concluded that three key enablers improved responses:

  • Leadership, culture and governance
  • Infection prevention and control expertise
  • Local planning and coordination

The study also highlighted four issues that challenged providers:

  • Planning for underserved and vulnerable populations
  • Reporting data 
  • Getting technical assistance
  • Managing federal, state, tribal, local and territorial guidance

The study wasn’t conducted for oversight, CMS said, but to better anticipate future needs.
The findings come as some health experts note the similarities between the responses to Covid-19 and the recent monkeypox outbreak — especially when similar issues are faced, such as unequal distribution of treatments across different demographic groups.

Abortion

BIDEN GETS ABORTION WIN IN IDAHO — A federal judge on Wednesday blocked part of Idaho’s near-total abortion ban — siding with the Biden administration in a key test case for what legal strategies might prevail in a post-Roe America, POLITICO’s Alice Miranda Ollstein reports.

U.S. District Judge B. Lynn Winmill in Boise issued a preliminary injunction, ruling that the state law, which was set to take effect on Thursday, doesn’t provide adequate protection for doctors who perform abortions during a medical emergency and therefore runs afoul of federal law guaranteeing patients the right to treatment when their health or life is at risk.

“The Court does not find the State’s argument persuasive because it has failed to properly account for the staggeringly broad scope of its law, which has been accurately characterized by this Court and the Idaho Supreme Court as a ‘Total Abortion Ban,’” wrote Winmill, a Clinton appointee.

The federal government’s challenge represents one of its most aggressive actions to preserve abortion rights since the Supreme Court overturned Roe v. Wade in June. The lawsuit followed weeks of complaints from Democratic advocates and elected officials that the administration hasn’t done enough to push back as abortion access has crumbled in nearly a dozen states.

By contrast, the Idaho decision also comes the day after a federal judge in Texas, appointed by former President Donald Trump, blocked the Biden administration’s guidance on abortion in medical emergencies within the state, siding with state officials who argued that it constituted an unlawful “abortion mandate” and didn’t give enough weight to the needs of “unborn children.”

POLL: CALIFORNIA ABORTION PROTECTION HAS SUPPORT — A California ballot initiative to protect abortion rights from state interference has strong support, POLITICO’s Lara Korte writes.

Over 70 percent of registered voters plan to vote for Proposition 1, which would amend the state constitution to protect abortion rights and contraceptive access, according to a poll from the UC Berkeley Institute of Governmental Studies.

More than 80 percent of voters rate abortion as a key issue in the upcoming election as voters around the country have also found the issue increasingly important.

ABORTION KEY FOR TOSS-UP DISTRICTS? — That’s a question pundits are considering, especially after Democratic candidate Pat Ryan’s performance in Tuesday’s primary in New York’s 19th Congressional District, POLITICO’s Eugene Daniels and Ryan Lizza point out in an election postgame.

Ryan’s campaign emphasized the need to fight for abortion rights, and some strategists have suggested the messaging was key in his victory — in a district where he even outperformed Biden’s 2020 results.

The district, won by Biden — as well as Donald Trump and Barack Obama — is now seen as a sign that Dems could come out of the midterms better than previously thought, perhaps even enough to buck historical trends, POLITICO’s Zach Montellaro writes.

 

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Covid

FIRST LADY REBOUNDS — First Lady Jill Biden tested positive for Covid-19 in a rebound case, POLITICO’s Kelly Hooper writes.

Though her symptoms haven’t reemerged, she’ll stay in Delaware to isolate. President Joe Biden, considered a close contact, tested negative Wednesday morning. He’ll wear a mask indoors when close to others for the next 10 days, a White House official said.

Around the World

DOSE-SPARING STRATEGY SPREADS — European health officials are looking to stretch their monkeypox vaccine doses by giving a fifth of a normal dose intradermally, POLITICO’s Sarah-Taïssir Bencharif reports.

Belgium’s national health emergencies committee meets today to decide whether to adopt the strategy — after the European Medicines Agency approved the approach late last week.

Should the Belgian health officials approve smaller doses, the country would join the likes of the U.S., Italy and Spain in the approach.

Belgium has already had to delay the second dose of the two-shot course while supplies remain limited. The dose-sparing strategy could allow more doses to be given.

The decisions come as U.S. providers have reported issues with the strategy, including being unable to get as many doses out of each vial as previously expected.

Those reports have slightly dimmed the Biden administration’s hopes that dose-sparing would multiply the number of available doses without a hitch, almost instantly overcoming shortages.

Instead, it may have slowed down immediate efforts to vaccinate people at highest risk.

Still, the strategy might be more common than not if more countries adopt it in hopes of stretching a relatively small vaccine supply.

DOSE SUPPLIES EXPAND, TOO — Bavarian Nordic, the maker of the monkeypox vaccine, said Wednesday it will work with the Pan American Health Organization to get doses to Latin America and the Caribbean.

Deliveries of the doses are expected to begin next month.

 

A message from PhRMA:

Insurance companies and PBMs don’t pay full price for insulin. So why do patients? Rebates, discounts and other payments from manufacturers lower the cost of insulins by more than 80% on average. But insurers and PBMs don’t usually share these discounts directly with patients. Congress should address the system we use to pay for medicines. Fix harmful insurance practices and lower out-of-pocket costs for patients. Stand up for patients.

 
What We're Reading

A prominent vaccine skeptic is back on Twitter after suing over his removal, The Atlantic’s Kaitlyn Tiffany writes.

The wife of a California congressman died after taking an herbal remedy that is generally considered safe, Kaiser Health News’ Samantha Young Reports.

Vape companies are openly flouting the FDA’s orders by making and selling “illicit” products, Stat’s Nicholas Florko and Elissa Welle report.

Kaiser Health News’ Jazmin Orozco Rodriguez goes inside a needle exchange program — modeled on urban efforts — in rural Nevada.

 

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