Presented by Facebook: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy. | | | | By Adam Cancryn and Sarah Owermohle | Presented by Facebook | With Rachel Roubein, Alice Miranda Ollstein and David Lim Editor’s Note: POLITICO Pulse is a free version of POLITICO Pro Health Care's morning newsletter, which is delivered to our s each morning at 6 a.m. The POLITICO Pro platform combines the news you need with tools you can use to take action on the day’s biggest stories. Act on the news with POLITICO Pro. | | — President Joe Biden's new spending proposal offers plenty of reforms Democrats have championed — but stays far away from big health care initiatives. — A White House decision to send AstraZeneca vaccines abroad stunned some senior officials, who'd spent the past month sparring over when to share doses with the rest of the world. — The FDA is considering restricting the sale of three cancer therapies, in an early test for acting agency chief Janet Woodcock. WELCOME TO WEDNESDAY PULSE — We’d never ask you your favorite PULSE cat , they’re all great, but if you have opinions and tips send them to acancryn@politico.com and sowermohle@politico.com. | A message from Facebook: How Facebook is supporting the COVID-19 vaccination effort
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The background: We’re helping people learn when and where they can get vaccinated, giving free ad credits to governments and NGOs and expanding efforts to remove false vaccine claims. | | | | BIDEN’s NEW ECONOMIC PLAN LEAVES HEALTH BATTLES BEHIND — The sweeping American Families Plan that Biden plans to unveil today is heavy on spending but light on Democratic health care ambitions. Gone are proposals for overhauling Medicare and Medicaid or slashing drug prices, in the wake of intense lobbying on and off Capitol Hill, POLITICO’s Alice Miranda Ollstein and Susannah Luthi report. The only key health provision left standing: Language to make recent boosts to Obamacare subsidies permanent, an idea that enjoys broad support among both Democrats and the health care industry. Administration officials insist Biden remains “fully committed” to drug pricing in particular, with the president planning to bring up the need for the government to directly negotiate prices during his speech later tonight. A summary of Biden’s proposal distributed to reporters also emphasized he “has a plan” to create a public insurance option and expand Medicare and Medicaid coverage — campaign vows that will nevertheless be left out of the bill. But that's not nearly enough for progressives and others who’d hoped Biden would go big on health care — and means that congressional leaders will have to take it upon themselves if they want to deliver on any of the party’s health reform goals before the 2022 midterms. “Everybody in the world knows that hearing, teeth and eyes are all health care,” Sen. Bernie Sanders (I-Vt.) said, vowing to introduce his own health bill after Medicaid coverage expansion failed to make it into the bill. “And yet we have not yet expanded Medicaid to cover those basic health care needs. Now’s the time to do it.” | | JOIN AN IMPORTANT CONVERSATION, SUBSCRIBE TO "THE RECAST": Power is shifting in Washington and across the country. More people are demanding a seat at the table, insisting that all politics is personal and not all policy is equitable. “The Recast” is a twice-weekly newsletter that explores the changing power dynamics in Washington and breaks down how race and identity are recasting politics and policy across America. Get fresh insights, scoops and dispatches on this crucial intersection from across the country and hear critical new voices that challenge business as usual. Don't miss out, SUBSCRIBE . Thank you to our sponsor, Intel. | | | THE VACCINE DECISION SPLITTING THE WHITE HOUSE — The sudden announcement Monday that the U.S. will send millions of doses of AstraZeneca vaccine sparked new questions about whether Biden will support a sustained effort this year to export doses overseas , POLITICO’s Erin Banco and Adam report. For weeks, the White House had rebuffed requests to send any vaccines abroad — a stance that created a rift among those working on the Covid response. As far back as early March, top USAID and health agency officials pushed for sharing doses with other countries, citing projections that showed the U.S. would have plenty to spare. But West Wing and National Security Council aides worried about the optics, and were shaken by the sudden production setbacks suffered by Johnson & Johnson. Even after the AstraZeneca announcement, there is no clear timeline for shipping those doses abroad. Though the U.S. has fielded multiple requests, a team led by State Department Covid coordinator Gayle Smith is still discussing how to decide which countries should receive vaccines first. FDA SCRUTINIZES PRICEY CANCER DRUGS — What should be done about expensive cancer drugs on the market that might not work? That could be the first thorny question to confront Woodcock, who is acting FDA commissioner while Biden weighs whether to nominate her for the full-time role. The FDA is convening an expert panel this week to discuss whether the agency should revoke approved uses of three therapies that, despite positive signs from early research, failed to help patients with certain cancers live longer. All three medicines were approved under Woodcock’s tenure as drug chief and after increasingly speedy reviews. Drug regulators “wanted to get these drugs to market as quickly as possible,” said Diana Zuckerman, a drug safety expert and president of the National Center for Health Research, who is presenting several times at this week’s meeting. “That was clearly their goal and they succeeded in doing it. But now there is a reckoning.” What the companies say: Genentech, Merck and Bristol-Myers Squibb, the companies at the center of the debate, say their drugs still have value against the cancers in question, they just need to do more research. And Genentech on Tuesday applauded the advisory panel’s vote to keep its drug on the market for triple-negative breast cancer, one of the approvals in question. | Inside the Humphrey Building | | BIDEN WALKS BACK TRUMP HOSPITAL REPORTING REQUIREMENT — In a win for the hospital lobby, the Biden administration is now aiming to unwind an attempt by Trump officials to tie hospitals’ Medicare payments more closely to market prices, POLITICO’s Rachel Roubein and Susannah Luthi report. — What’s changing: CMS is proposing ditching a new mandate that hospitals disclose certain rates they contract with private Medicare plans on their cost reports. Hospitals that complained about the provision last year applauded the Medicare agency’s move, with one provider group, America’s Essential Hospitals, even saying the Trump-era plan had “exceeded the agency’s statutory authority.” BECERRA TO ADD FDA SPECIALIST — HHS Secretary Xavier Becerra is bringing on Obama-era health official Stephen Cha as a counselor in his immediate office focused on FDA issues, two people with knowledge of the decision told PULSE. Cha, who officially starts next Monday, spent nearly seven years at CMS spanning the Obama administration and the beginning of the Trump era, first in the agency’s Center for Medicaid and later at its Innovation Center. He’ll join the Biden HHS from UnitedHealthcare Community & State, where he was the health benefits company’s chief medical officer. THINK TANK WANTS TRUMP-ERA POLICIES RESCINDED — The Pew Charitable Trusts is asking Becerra to pull back Trump-era policies mandating five-year job reviews for certain senior government health officials and preventing the FDA from being able to require premarket review of certain Covid-19 tests, David Lim writes, The “term limit” policy — first reported by POLITICO — was put into place during the final week of former President Donald Trump’s term and would put career officials up for five-year reviews, after which they could be reassigned. The measure “could make senior staff more susceptible to political pressures, particularly if they know their position may be threatened by taking a politically unpopular stance,” Pew’s Liz Richardson wrote in the Wednesday letter. Pew also urged Becerra to bolster FDA’s authority to regulate lab-developed tests after a Trump-era regulation peeling back premarket review. In a separate letter sent Tuesday to Biden, the American Clinical Laboratory Association said its members “need clarity and certainty” about how those same tests are regulated. David writes that the commercial lab lobby historically has argued FDA does not have the regulatory authority to oversee lab-developed tests. But both Pew and the ACLA are asking the Biden administration to push for legislation that establishes a universal framework to regulate both lab-developed tests and diagnostic tests. | | | | | | TODAY: ‘LONG COVID’ GETS A HOUSE HEARING — NIH Director Francis Collins will be among those testifying in front of the House Energy and Commerce Committee on how the government should respond to the growing number of people suffering from so-called long Covid — coronavirus symptoms that linger for months after infection. Senior CDC official John Brooks and a pair of academic researchers are also slated to appear at the session, which comes as advocates have rallied behind a proposal allocating $90 million to gather better data on long Covid patients. | | Hannah Mooney Mack will be the director of biopharma communications for Avantor, a Pennsylvania-based life sciences company. She most recently was director of public affairs at the biopharmaceutical industry trade lobby, PhRMA. | A message from Facebook: Get timely, reliable information about COVID-19 and vaccines
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· When and where you can get the COVID-19 vaccine · Real-time updates from national health authorities and global organizations · Tips and resources to stop community spread and support emotional health | | | | Endometriosis is a misunderstood disease and is often sidelined in medical research. MIT scientist Linda Griffith is seeking to change that with research into biomarkers and genetics, New York Times’ Rachel Gross reports. China reported 12 new Covid-19 cases Monday after 11 cases a day earlier, marking what could be an alarming recurrence of the virus, Reuters reports. “If there is an apocalypse, this has to be one”: Vikas Dandekar describes the devastation of India’s Covid-19 surge in Stat News. | | CHECK OUT FDA TODAY: Daily regulatory developments, sent directly to your inbox. AgencyIQ's daily newsletter, FDA Today, provides readers with actionable and insightful explanations of the latest FDA developments impacting the life sciences industry. Sign up for free today. | | | | | Follow us on Twitter | | Follow us | | | | |