| |   | Hello, D.C. Diagnosis readers. Please join me in welcoming Bob Herman on his second day as STAT’s Business of Health Care Reporter. I’m sure most of you are very familiar with Bob’s fantastic reporting unraveling the absurdities of this nation’s health care system. We are so happy to have him. Please, send him tips! He’s at bob.herman@statnews.com. | | | A top Trump official spills the tea on Operation Warp Speed Pfizer and the team at Operation Warp Speed really, really did not get along – and it had an impact on the early days of the Covid-19 rollout, according to a new book from Paul Mango, a top official involved in the Warp Speed effort. Mango’s book is peppered with a number of allegations against Pfizer, including that the company failed to deliver on some of the contractual obligations for its vaccines and that it refused to answer certain questions from the administration or let it observe its manufacturing processes. The book even alleges that Pfizer demanded it be paid extra after doctors realized they could extract a sixth dose of vaccine out of vials in the early days of the vaccination effort. The allegations have already sparked a new war of words. A Pfizer spokesperson called the allegations “politically-motivated, unfair, and misleading.” For more drama, check out my new story for STAT here. | A SOTU dilemma: Biden went all-in on Covid-19, but voters increasingly aren’t impressed President Biden will deliver his first State of the Union address tonight. It would seem a chance for him to highlight the massive efforts he has stood up to right the United States’ Covid-19 response. But the harsh reality is this: Biden’s Covid-19 response is a political liability. A new poll released today by Kaiser Family Foundation finds that just 39% of voters would describe the president’s pandemic response as excellent or good. It’s the latest example in a long line of polling showing Biden’s Covid approval ratings tanking. The new polling underscores how much of a messaging test the State of the Union is shaping up to be for the White House, which will use the speech to drum up support for Biden’s agenda ahead of a tight November midterm election. Already, there are reports that the administration will take the cautious route and stop short of declaring victory against Covid. Instead, Biden will emphasize the progress the country has made and the need to stay focused on combatting the virus. Already, experts are doubting that that approach will do much to reverse the flailing ratings. “The president can't really get benefit unless [Covid has] gone away and people are back to normal,” said Bob Blendon, an expert on health care and public opinion polling at Harvard University. “You don’t get credit for effort, you get credit [if] the problem goes away.” Beyond Covid, a few SOTU health policy specifics: While Biden is expected to reprise calls to lower health care costs for prescription drugs and premiums, the major new health policy initiative he will be unveiling is a major crackdown on the nursing home industry — in particular, the 5% of nursing homes owned by private equity firms. The White House is planning to: - institute mandatory staffing levels
- ask Congress for more money to conduct inspections
- toughen accountability programs for nursing homes that perform the worst on quality measures
- ask Congress to keep companies that own underperforming nursing homes from opening new facilities
- examine the role of private equity and other investment ownership in the nursing home sector
| On March 31, take an inside look at the technologies and procedures set to redefine medicine, and change patient care in the years to come. You’ll hear from the CEOs, scientists, entrepreneurs at the forefront of these efforts. Get your pass now, and use your STAT+ subscriber login to unlock a 20% discount. | The FDA’s promised menthol ban is about to face a critical test The FDA is finally moving forward with a long-promised regulation banning menthol cigarettes, according to a website maintained by the White House office that reviews regulations before they are published. Even this tiny, early step is a major victory for public health groups, which have been locked in a multi-year legal battle with the FDA attempting to force the agency to ban menthol products. But the regulation will still face a major test: Escaping the White House Office of Management and Budget’s clearance process unscathed. After all, OMB has widespread power to kill or waterdown controversial regulations, and it’s done so before on tobacco issues: The Obama administration's efforts to ban flavored vaping products was stymied by the OMB amid a pressure campaign from tobacco companies. “In administrations past, OMB is where [regulations] go to die,” said Matt Myers, the president of the Campaign for Tobacco-Free Kids, which supports a menthol ban. “This administration has made a commitment to move forward on this specific rule, and what OMB does will be a critical test of their commitment.”
The review process will also mark one of the first tests for Robert Califf, the newly minted FDA commissioner, who will likely have to work political levers to make sure the regulation is released quickly. Califf oversaw earlier efforts to ban flavored products during his last sint at the FDA during the Obama administration, and had previously shown himself unable to combat the tobacco industry’s pressure. Back then, when Califf was asked why the Obama White House had killed the flavor vaping ban, he told the New York Times he simply did not know. | A major boost for NIH and FDA's private-sector partnerships Congress is dramatically increasing the amount of money that the NIH and FDA spend on research partnerships with the private sector — namely, collaborations with drug and device companies. A new bill from Sen. Ben Ray Lujan (D-N.M.) allows each agency to allocate more of its own funding to the congressionally authorized nonprofits that facilitate the partnerships: the Reagan-Udall Foundation for the FDA and the Foundation for the NIH. The legislation, which passed the House last night and now heads to Biden's desk, raises each organization's minimum yearly funding to $1.25 million. The new maximum for each nonprofit is $5 million, a fourfold increase. The legislation doesn't specify which projects the new money will be used for. In the past, some private-sector partnerships have encountered controversy, like aborted projects with the NFL and the alcohol industry. More recent ones, though, have been more successful, like a $215 million team-up on cancer immunotherapies and a number of efforts to develop Covid diagnostics, tests, and vaccines. | STAT stories you may have missed Oregon’s Medicaid program has given up on its request to restrict patient access to certain drugs. STAT and MIT launched an experiment to root out the weaknesses of common AI tools used in hospitals. A new study finds that Pfizer’s Covid-19 vaccine produces a lackluster immune response in children 5-11. A new FDA report demonstrates that certain compounding pharmacies are still having problems with basic sanitation. Health insurance startups are betting on software to get them into the black. A federal court struck down a portion of the Biden administration's interpretation of the controversial surprise billing law.
It’s official: Martin Shkreli can never lead another publicly traded company. | Thanks for reading! More next week,  | | | |
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