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Vaccine guidelines pit Trump against his own FDA

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With Rachel Roubein and Susannah Luthi

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— President Donald Trump is threatening to reject new, more stringent FDA guidelines for evaluating a coronavirus vaccine for emergency use.

— Trump is expected to spotlight health care during a speech today, but his remarks aren’t likely to include many policy specifics.

— The nation’s fight against coronavirus could draw on lessons learned from yearslong efforts to combat sexually transmitted diseases.

WELCOME TO THURSDAY PULSE — where the Los Angeles Chargers’ biggest on-field threat might just be the team doctor.

What ICD-10 code does “punctured lung with a painkiller injection” fall under? Send ideas and tips to [email protected] and [email protected].

TRUMP UNDERCUTS FDA OVER VACCINE GUIDELINES — A much-anticipated effort to lay out new guidelines for evaluating a potential coronavirus vaccine is suddenly hanging in the balance, after Trump on Wednesday threatened to reject the new FDA standards, POLITICO’s Lauren Morello and Adam Cancryn report.

The president’s opposition sets him on a collision course with his own FDA, which views the guidelines as critical to boosting public confidence in any eventual coronavirus vaccine.

— Trump’s view: The revised standards are a “political move.” The president — who has repeatedly pledged a vaccine will be available by Election Day — complained during a press briefing that requiring vaccines to meet more stringent standards to secure emergency authorization could add “great length to the process.”

— That skepticism caught the FDA by surprise. The agency had circulated the proposal widely and gotten it cleared through HHS earlier this week, with the expectation the White House would soon sign off. But Trump expressed his disapproval hours after he was briefed on the proposal by HHS Secretary Alex Azar.

— The dispute puts the spotlight on STEPHEN HAHN. The FDA commissioner just vowed to stand up to any political pressure, testifying Wednesday morning that he “will fight for science” and “fight for the integrity of the agency.” The fate of the new vaccine standards — which have been telegraphed for days as stricter than the initial June guidance — could prove the first test of those assertions.

TODAY: TRUMP MAKES FRESH PUSH ON HEALTH CARE — The president will tout what’s been dubbed the “America First Health Care Plan” during a speech in North Carolina today — but don’t tune in expecting a ton of policy specifics, POLITICO’s Susannah Luthi and Rachel Roubein report.

A White House briefing Wednesday to preview the announcements offered scant details, according to two sources on the call. And officials focused on pushing the message that even if the Supreme Court eliminates Obamacare, the Trump administration will ensure Americans keep their pre-existing condition coverage.

— It’s all about the packaging: Despite teasing a new health care plan for months, Trump is likely to focus his speech on a slew of existing policies. And while he’s vowed to eliminate “surprise” medical billing, White House officials on the preview call gave no details on what impact any executive actions could have on the issue.

— The pre-ex conundrum: Trump has long insisted that he supports pre-existing condition protections, despite backing the GOP’s lawsuit to gut Obamacare and having no replacement plan of his own.

That wobbly claim has only grown thinner over the week, with Trump poised to add another conservative justice to the Supreme Court who might quickly prove the decisive vote in wiping out Obamacare and throwing the nation’s health system into disarray.

WHAT STDs CAN TEACH US ABOUT FIGHTING COVID — The pandemic has forced Americans to confront a new series of challenges around testing, tracing and mask wearing. But for a certain set of public health experts working to eradicate sexually transmitted diseases, the debates of the past six months are eerily familiar, POLITICO’s Alice Miranda Ollstein reports.

The lessons from those yearslong efforts against diseases like HIV and syphilis could make a major difference now in how the nation combats the coronavirus. Those include:

— Cutting out the shaming. Scaring or shaming people into compliance often backfires, sexual health experts warned. Instead, convincing people to do things like wear masks often takes a softer touch — or an appeal to their own sense of altruism.

— Making testing easy and available. Routine screening has proven successful in limiting STD epidemics, in the same way that health experts argue free and convenient coronavirus testing could help keep a lid on new flare-ups across the country.

— Building trust with marginalized groups. Communities of color have suffered disproportionately from STDs and Covid-19 — a gap that requires concerted efforts to reach minority groups and establish connections within underserved parts of the population.

POLITICO-HARVARD POLL: VOTERS PAN TRUMP’S COVID-19 RESPONSE — A clear majority of voters disapprove of the Trump administration’s coronavirus response. The question is how much that will play into their decisions come Election Day, POLITICO’s Gabrielle Wanneh reports.

A new POLITICO-Harvard poll finds that 55 percent of respondents disapprove of the federal government’s handling of Covid-19, with 57 percent unhappy with Trump’s performance in particular. Those views, though, diverge sharply based on political affiliation: 91 percent of Trump voters approved of the president’s performance, while 94 percent of Biden supporters disapproved of Trump.

— Where Covid-19 ranks overall: The pandemic tied for third among the top issues for likely voters, with 35 percent ranking it as extremely important in deciding their vote. Of those, more than 40 percent listed their focus as the competency of the federal government’s response. Another 30 percent said they’re paying more attention to school and business shutdowns and reopenings.

— A viable vaccine isn’t a game-changer. At least not politically, the poll finds, with the vast majority of voters on either side saying they won’t change their vote if a safe and effective vaccine is developed before the election.

CHILDHOOD VACCINATIONS, MEDICAL CARE PLUNGE AMID PANDEMIC — Mental health, dental and childhood screening visits dropped significantly for children covered by Medicaid and CHIP during the coronavirus pandemic, Rachel reports.

That’s according to a new CMS analysis that came with a stark warning: The decline may have a long-term impact on some of the most vulnerable children, such as those living in poverty or with special health needs. Among the findings:

— There were 22 percent, or 1.7 million, fewer vaccinations for children up to age 2 between March and May, compared to that same time last year.

— About 7.6 million, or 69 percent, fewer children saw a dentist.

— About 44 percent, or 6.9 million, fewer children saw outpatient mental health services, and that includes telehealth visits.

‘PULSE CHECK’: MURPHY ON WHY SCOTUS FIGHT IS ‘ANOTHER REPEAL DEBATE’ — Sen. Chris Murphy joined POLITICO’s “Pulse Check” podcast to discuss Democrats’ effort to slow the likely confirmation fight over the next Supreme Court justice by making it a referendum on health care amid a pandemic.

“If President Trump gets his selection put onto the court, the Affordable Care Act will be repealed. Period. Stop,” Murphy said, pointing to the Obamacare challenge that’s scheduled to be heard by the high court in November. The Connecticut Democrat argued that his party’s success at stopping ACA repeal in 2017, by focusing on the implications of losing the health law’s pre-existing condition protections and other benefits, was a playbook to similarly delay Trump’s nominee in 2020.

“We know enough about coronavirus to note that it very likely becomes a pre-existing condition,” Murphy added, pointing to how Covid-19 has been linked to heart damage. “Insurance companies are going to take advantage of that… And they are certainly going to raise rates on anyone who has had a covid diagnosis.” Listen to the episode.

DEMS TO AZAR: LIFT FETAL TISSUE RESTRICTIONS IMMEDIATELY — Congressional Democrats are demanding that HHS resume federal funding of research projects that use fetal tissue, citing the pandemic and a recent House Oversight probe into the administration’s restrictive policy.

“The Trump Administration’s failure to combat this crisis has cost lives, and the Administration must let science lead the way in order to save lives,” the Democrats write in a letter led by Reps. Jan Schakowsky and Mark Pocan and Sen. Tammy Baldwin and shared first with PULSE. “We urge you to stand up for science, preserve scientific integrity, and use your authority to stop ideologically motivated efforts to restrict federally funded biomedical research using fetal tissue.”

HHS last year announced a series of restrictions on use of the tissue, including the creation of a new ethics advisory board that recently advised HHS Secretary Alex Azar to reject funding for 13 proposals that had already been deemed worthy of funding by NIH scientists. The administration’s restrictions have been broadly opposed in the research community and by some HHS scientists — who maintain that using the tissue was essential for research into potential cures and vaccines — but cheered by the president’s supporters in the anti-abortion movement.

The House Oversight committee this month released documents from an investigation into the HHS policy, arguing that the findings show officials were driven by political considerations despite their promise to follow the science.

HHS WARNS ELI LILLY OVER DISCOUNT PROGRAM CUTBACKS — The department’s top lawyer blasted Eli Lilly over its decision to limit the number of drugs it sells to certain hospitals and clinics through a federal discount program, Susannah reports.

General Counsel Robert Charrow in a letter to the drugmaker said he’s still reviewing the legality of the move, in what amounts to the first official government rebuke of similar moves in the pharmaceutical industry.

Eli Lilly is one of five companies to flout the rules that companies have long followed in the 340B program, opting on Sept. 1 to halt discounts to pharmacies contracted to hospitals and clinics in the program for all drugs except insulin — as long as the pharmacy doesn’t also charge patients or insurance companies for dispensing the insulin.

The National Academy of Medicine’s Leadership Consortium hosts a virtual session on health care after Covid. Surgeon General Jerome Adams is keynoting the session, while POLITICO’s Joanne Kenen will lead the final discussion about how to pick up the pieces as the closing speaker. She tells PULSE she’s going to talk a lot about trust — in medicine, in science and maybe, baby step by baby step, in our own ability to repair and rebuild. Listen in.

The heated debate over how Covid-19 spreads is having on-the-ground consequences inside hospitals – including what kind of protective gear health care workers get access to, Kaiser Health News’ Robert Lewis and Christina Jewett report.

The head of the FDA’s vaccine advisory committee is stepping aside over potential conflicts of interest, Reuters’ Dan Levine and Marisa Taylor report.

Some Covid-19 patients are showing signs of heart inflammation and injury months after they got sick, even in cases where the illness wasn’t severe, The Wall Street Journal’s Sarah Toy writes.

https://www.politico.com/newsletters/politico-pulse/2020/09/24/vaccine-guidelines-pit-trump-against-his-own-fda-790608

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