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With Alice Miranda Ollstein and Sarah Owermohle
— The FDA granted an emergency authorization for a coronavirus treatment amid public pressure from President Donald Trump.
— FDA’s leader is trying to signal the agency’s independence despite the attacks from Trump and others.
— Trump’s second-term agenda includes several health care goals, according to a list released Sunday night by the campaign.
WELCOME BACK TO MONDAY PULSE — Where the FDA should consider nationwide emergency access to NBA star Luka Doncic, given Doncic’s effectiveness at dealing with “Pandemic P.” Send quips and tips to dd[email protected] and [email protected].
WHEN PUBLIC HEALTH AND POLITICS COLLIDE — Trump has made no secret of his desire to see coronavirus breakthroughs before Election Day, and now he’s openly accusing career government officials of standing in his way.
“The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” the president tweeted on Saturday, tagging FDA’s commissioner. “Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”
— Trump’s attacks are a major breach of the historic divide between the executive branch and the government’s career scientists, a firewall that seems to be collapsing by the day as other officials join in.
The president “had to make sure that [FDA] felt the heat,” White House chief of staff Mark Meadows said Sunday. “If they don’t see the light, they need to feel the heat, because the American people are suffering.”
It’s also an alarming development, raising the possibility that coronavirus strategies are being made with political considerations.
— But it doesn’t necessarily mean that every decision is shaped by Trump, including Sunday night’s emergency authorization on convalescent plasma, which was in the works before the president’s tweets this weekend.
“The FDA professional staff supported this,” former FDA commissioner Scott Gottlieb tweeted on Sunday night. “It’s their decision.”
LOOKING CLOSER: THE CONTROVERSIAL PLASMA ORDER — Trump announced the emergency authorization alongside his health secretary, Alex Azar, and FDA Commissioner Stephen Hahn, in a press conference one day before the start of the Republican National Convention.
While Trump called it a “historic announcement,” experts have said the treatment is unlikely to be a game-changer in the fight against a pathogen that’s killed more than 170,000 in the United States, POLITICO’s Zachary Brennan and Sarah Owermohle report.
— FDA was close to announcing the decision last week but held off over concerns from government scientists that evidence for the treatment’s effectiveness is thin. It is not clear whether the FDA has received additional clinical trial data in the last week that would support the therapy’s use, Zach and Sarah write.
FDA’s emergency use authorization for the infusion also took pains to note that more data was needed to determine whether it was effective. The agency’s top drug official, Janet Woodcock, told POLITICO on Friday that it had not yet been proven.
MEANWHILE: FDA SEEKS TO ASSURE INDEPENDENCE. WILL IT BE ENOUGH? — Prior to Sunday night, Hahn had been stepping up efforts to convince Americans that his agency won’t sacrifice the safety or efficacy of a coronavirus vaccine for the sake of speed — even as Trump is urging the agency to move faster on Covid-19 cures.
But it’s not clear whether Hahn’s efforts will persuade Americans who are hesitant about taking a coronavirus vaccine to do so. It’s a two-front battle for the agency: Rebuff any outside pressure, and convince the public that it has.
Polls show that nearly a fifth of adults would refuse a coronavirus vaccine if one were available, in some cases over fears that any approval would be motivated by politics rather than science. Just 14 percent of voters would be more likely to take a vaccine recommended by Trump, according to a POLITICO/Morning Consult poll this month.
“The national conscience has been traumatized over the past six months,” said one current senior health official. “People just don’t know what to believe. On top of that, it’s an election year.”
— Hahn, the nation’s top drug regulator, has been pumping out op-eds and popping up at scientific conferences in recent weeks to make the case for his agency’s independence. “FDA commissioner: No matter what, only a safe, effective vaccine will get our approval,” read the headline on a Washington Post piece Hahn wrote this month. “Unwavering regulatory safeguards for Covid-19 vaccines,” read another, published days later in the medical journal JAMA.
“It’s the job of the FDA commissioner, to make sure that the American people trust the agency,” said David Kessler, the longtime FDA commissioner who now advises the Joe Biden presidential campaign on the coronavirus response. “The other big job of the FDA commissioner is to put their body on the line in between all the forces that want to influence the agency.”
TRUMP’s STILL-VAGUE SECOND-TERM HEALTH AGENDA — The campaign announced a bulleted list of “core priorities,” including seven health care-related goals.
“President Trump will further illuminate these plans during his acceptance speech Thursday at the Republican National Convention,” the campaign said in a statement.
— Many second-term priorities should look familiar: They were on Trump’s first-term agenda. The president is again vowing to cut prescription drug prices, lower premiums and give more power to patients, which are all promises he made in his 2016 campaign.
While these are standard aspirations — lowering health costs is a semi-permanent goal for any politician — they also reflect the Trump administration’s inability to make major headway on longstanding health problems that similarly flummoxed his predecessors. As Trump quickly learned, each administration faces industry resistance and the reality that health care is complicated.
Even newer pledges are old staples for Trump. For instance, he is vowing to “end surprise billing” — a demand that he made on May 9, 2019.
— What’s notably missing: Any explicit mention of tackling Obamacare in Trump’s second term, after Republicans spent much of 2017 trying and failing to repeal the law in what’s now viewed as a political disaster.
The Trump administration is still seeking to overturn the ACA in the courts, with the Supreme Court set to hear oral arguments on Nov. 10 — a week after the election.
FIRST IN PULSE: HOUSE BILL WOULD FORCE TRUMP TO FULLY FUND NATIONAL GUARD’S PANDEMIC WORK — A House bill introduced Monday would force the Trump administration cover the full cost of National Guard deployments across the U.S. for the duration of the coronavirus pandemic, regardless of when it ends, POLITICO’s Alice Miranda Ollstein reports.
The new push comes as 44 states and territories saw federal funding for their Guard relief work drop by 25 percent over the weekend. Full funding remains for just five states: Texas, Florida, Arizona, California and Connecticut.
The White House has yet to explain why these states were selected, saying only that their governors made “direct appeals” to the president. But many other states have attempted unsuccessfully, in letters and phone calls, to do so, prompting accusations of political favoritism.
“The COVID-19 pandemic has wreaked havoc on every budget and these inexplicable maneuvers further prove the Administration lacks a consistent strategy to ensure our governors and neighbors in uniform are not shortchanged throughout this crisis,” Rep. Cheri Bustos (D-Ill.) the lead sponsor of the bill, told Alice.
The cut comes as roughly 25,000 Guard members are deployed throughout the country running testing sites, conducting contact tracing, sanitizing nursing homes and delivering food to people in quarantine. Many states say they will struggle to afford paying a quarter of the cost, and may be forced to make cuts to other government services.
Federation of American Hospitals looks at health equity issues. The organization is launching a new podcast series that explores the connection between hospitals and social determinants of health, featuring speakers like Georges Benjamin, Executive Director of the American Public Health Association, and Rep. Lauren Underwood (D-Ill).
Trade adviser Peter Navarro spearheaded the idea for Kodak to play a major role in drug production — until the plan blew up, the WSJ reports.
Taking action on biosimilars could help achieve lower drug prices, former Trump administration official John Michael O’Brien argues in the Sarasota Herald-Tribune.
The Trump administration’s plan to send fast, cheap coronvirus tests to nursing homes could have a hitch, Rachana Pradhan writes for Kaiser Health News.
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