| | | | |  | | By Katherine Ellen Foley | | | With Alice Miranda Ollstein and Megan R. Wilson Editor's Note: POLITICO Pulse is a free version of POLITICO Pro Health Care's morning newsletter, which is delivered to our subscribers 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.
| | | — CDC is considering what metrics could inform guidance on easing pandemic precautions. — Sens. Rosen and Murkowski introduce bill funding support for student mental health. — Califf earns Sen. Wyden's support the FDA commissioner, though his confirmation is still far from certain. Happy Thursday. Welcome back to Pulse. Happening today: President Biden travels to Culpeper, Va. to talk about federal efforts to lower prescription drug costs; HHS Sec. Xavier Becerra will also deliver remarks. Send tips, feedback and pictures of your cats to kfoley@politico.com or @katherineefoley.
| | | | A message from PhRMA: Washington is talking about price setting of medicines, but it won't stop insurers from shifting costs to you. And it will risk access to medicines and future cures. Instead, let's cap your out-of-pocket costs, stop middlemen from pocketing your discounts and make insurance work for you. Let's protect patients. It's the right choice. Learn more. | | | | | | MASK METRICS: CDC CONSIDERS CRITERIA FOR LIFTING COVID PRECAUTIONS — CDC scientists and officials are weighing which public health metrics should inform guidance on public health interventions like masking, POLITICO's Erin Banco and Adam Cancryn report. The agency's scramble comes as several states are planning to — or already have — dropped some of the Covid-19 precautions and programs as cases continue to decline across the country. But without science-backed guidance, CDC and White House officials fear the country is still in the thick of a public health crisis, with over 200,000 new cases daily and 2,500 deaths every day last week. And it could get worse if another more-transmissible variant emerges in the coming weeks and months. Any change in CDC messaging around Covid-19 metrics could impact whether state and local officials continue to lift mask mandates, including in schools. Pick your data, any data: Case counts don't tell the whole story, some scientists warn. "We should not be using case numbers at all when making decisions about restrictions. The case numbers are not reliable," said Leana Wen, an emergency physician and public health professor at George Washington University. The CDC has access to all kinds of Covid data, from vaccinations to hospitalizations to deaths, and even wonkier forms of data like the presence of the SARS-CoV-2 virus in wastewater. The trick is figuring out which of these metrics — or combinations of them — are enough to say that states and localities are in a safe position to loosen Covid-19 precautions. The CDC is taking input from external scientists to make these decisions. But as it decides, its director, Rochelle Walensky, remains firm that masks still play a crucial role in keeping the pandemic at bay. "At this time, we continue to recommend masking in areas of high and substantial transmission. That's most of the country right now," she said in a press conference Wednesday. A noncommittal response from the White House: While CDC deliberates best practices, White House press secretary Jen Psaki had a more lenient response later in the day. She told reporters the CDC would be reviewing its guidance but that "our goal remains continuing to ensure that there is guidance that helps school districts stay open."
| | | PULSE EXCLUSIVE: ROSEN, MURKOWSKI INTRODUCE BIPARTISAN BILL TO ADDRESS YOUTH MENTAL HEALTH — Today, Sen. Jacky Rosen (D-Nev.) and Lisa Murkowski (R-Alaska) introduced a bill that would authorize HHS' Substance Abuse and Mental Health Services Administration to provide direct funding assistance to K-12 school districts for comprehensive student mental health promotion and suicide prevention efforts. The bill, backed by the American Psychological Association and the American Foundation for Suicide Prevention, would allow SAMHSA to grant funding for programs to train students and school staff on how to promote effective responses to mental health issues and suicide attempts. The bill would also support utilizing social media and telehealth to conduct suicide risk and mental health screenings for students. Currently, SAMHSA can only grant such funding to colleges and universities. "As we work together to recover from COVID-19, we must prioritize supporting our students and their mental health needs," Sen. Rosen said in a statement. In 2020, Clark County, Nevada, saw an increase in student suicide rates as schools went virtual. Rep.Tony Cárdenas (D-Calif.) and Rep. Lori Trahan (D-Mass.) introduced a similar bill in the House in March 2021. WYDEN BACKS CALIFF AFTER FDA NOMINEE PROMISES MORE PHARMA OVERSIGHT — Senate Finance Chair Ron Wyden (D-Ore.) pledged his support for Biden's FDA nominee Robert Califf on Thursday after the former agency commissioner agreed to more oversight of drug companies that win accelerated approval for new medicines, Alice reports. After a meeting between the two last week, Wyden remained undecided on Califf and sent follow-up questions to the nominee, asking how he would hold drugmakers accountable for the promises they made about their products following accelerated approval. Califf responded this week that it would be a "high priority" for him, if confirmed, to make sure companies conduct confirmatory studies on the safety and efficacy of their drugs "in a timely manner." "It is incumbent upon the FDA to ensure that the work does not end with the initial approval," he wrote to Wyden. Following that pledge, Wyden declared he would back Califf. "I am prepared to support Dr. Califf's nomination so that he can shift the FDA into high gear," he said in a statement, adding that he hopes to see action from the agency on tobacco regulation, opioids and high drug prices. But his confirmation remains uncertain: A handful of Senate Democrats oppose him over his record on opioids when he led the FDA during the Obama administration and his subsequent private sector work, while the overwhelming majority of Republicans are against him because of his record on abortion pills. As the nomination teeters, conservative groups are preparing to ramp up pressure on the GOP. The anti-abortion group Students for Life is putting together an anti-Califf lobby day for next week when they'll pressure senators to block him from the post. His support for the agency's recent decision to allow abortion pills to be distributed by mail and telemedicine "should disqualify Dr. Califf from heading the FDA," the group's spokesperson Kristi Hamrick told Alice. Meanwhile, more public health groups voice their support for Califf: In a statement issued today, the heads of the American Heart Association, the American College of Cardiology and the Association of Black Cardiologists voiced their support for the Biden nominee. "We know from experience that Dr. Califf will prioritize science and evidence-based policymaking at the helm of the FDA, just as he has throughout his impressive career," the leaders wrote. "We urgently ask the Senate to confirm Dr. Califf with bipartisan support."
| | | FIRST IN PULSE: BIOTECH INDUSTRY PUSHES BACK AGAINST CMS ADUHELM COVERAGE — Biotech execs and investors wrote to Health Secretary Xavier Becerra on Thursday in vehement opposition to Medicare's proposal to drastically limit coverage of a controversial Alzheimer's drug to those in a clinical trial. The industry group BIO said that the proposed coverage determination — which would extend to the entire class of anti-Alzheimer's drugs — is "untenable from an investment standpoint," Megan reports. "CMS is harshly limiting patient access to a nascent class of drugs for a serious and life-threatening disease that lacks alternative treatments … sending a strong signal to the biotech investment and innovation market that FDA scientific determinations are now subject to CMS second-guessing," the letter reads. "Our future investments and research projects are all at risk in the currently proposed situation, and, again, patients will ultimately lose." Situational awareness: The FDA approved Aduhelm last June despite mixed evidence, contingent on Biogen, the manufacturer, conducting a follow-up study to prove it helped patients' symptoms. The controversy around the drug — and its sticker price of roughly $28,000 annually — has drawn vigilant attention to CMS' coverage determination. Several insurance companies have said they plan to follow the federal health agency's lead with their own coverage. The proposed coverage determination CMS issued in January has drawn strong responses from industry, patients, health care providers and lawmakers. Earlier this week, 78 House Republicans wrote to HHS asking the agency to justify the draft proposal. And yesterday, a group of more than 50 patient advocacy groups signed a letter from UsAgainstAlzheimer's to HHS, urging Medicare to broaden access to the drug in its final decision. Industry, patient advocates, health care providers and others can issue public comments on Medicare's draft coverage plan through today. At the time of writing, more than 6,200 comments were posted on the CMS website — although many can be attributed to letter-writing campaigns from advocacy groups. CMS will consider the comments before issuing its final coverage determination by April 11.
| | | | A message from PhRMA:   | | | | | | Ramona Sequeira, a top executive at Takeda Pharmaceuticals, has been named chair of PhRMA's board of directors — the first woman to ever serve in the role, Megan reports. Vas Narasimhan, CEO of Novartis, and Daniel O'Day, chairman and CEO of Gilead Sciences, have also assumed top spots on the board.
| | | For MIT Technology Review, Jane Qiu profiles Shi Zhengli, the director of a lab at the Wuhan Institute of Virology that focuses on coronaviruses that live in bats, who is at the heart of the SARS-CoV-2 lab leak controversy. The National Health Service Corps pledges to provide student loan assistance to the thousands of health care providers who apply to work in underserved areas, but pandemic layoffs have left many of those providers in violation of their contracts — and exposed to heavy fines as a result, Rebecca Smith and Rebecca Ballhaus report for The Wall Street Journal.
| | | | A message from PhRMA: Washington is talking about price setting of medicines, but it won't stop insurers from shifting costs to you. And it will risk access to medicines and future cures. Instead, let's cap your out-of-pocket costs, stop middlemen from pocketing your discounts and make insurance work for you. Let's protect patients. It's the right choice. Learn more. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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