Governors who championed Covid restrictions are transferring on- POLITICO

With Megan Messerly, Lauren Gardner, Sarah Owermohle, Alice Miranda Ollstein, Victoria Colliver, Megan Wilson and Darius Tahir

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— Democratic governors are increasingly dropping Covid-19 mitigation measures.

— Eric Lander’s late-night resignation hung over Tuesday’s House hearing on the Biden administration’s proposed Advanced Research Projects Agency for Health.

— Beth Cameron is leaving her global health security and biodefense role at the National Security Council.

It’s Wednesday. Welcome back to Pulse. Your pinch hitter normally resides over at FDA-focused Prescription Pulse. Send tips and feedback to David Lim ([email protected] or @davidalim).

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

LEARN TO LIVE WITH COVID — While Republican governors have long been eager to put the pandemic behind them, their Democratic counterparts are now following suit, Megan Messerly reports. On Monday, five states in the Northeast and West announced they would soon be loosening mask policies, and three more signaled they’re not far behind.

“We’re not going to manage Covid to zero,” said New Jersey Gov. Phil Murphy, a Democratic governor who on Monday announced he would lift the state’s school mask mandate. “We have to learn how to live with Covid as we move from a pandemic to the endemic phase of this virus.”

At the same time, health departments from Oregon to Maine have ended almost all of their government-run Covid-19 contact-tracing operations and shifted the responsibility to the public over the last few weeks.

What does it mean? Some health officials view the changes as a prelude to what managing Covid after the pandemic might look like, with individuals bearing the most responsibility for stopping the virus from spreading on day to day and health departments playing a supporting role in vaccinating, educating the public and stopping outbreaks in high-risk settings.

What do public health experts say? While politicians are eager to declare the pandemic is behind us as case counts continue to drop, public health experts are urging caution, noting warm weather and declining case counts have lulled Americans into a false sense of security before.

CAMERON LEAVING NATIONAL SECURITY COUNCIL — Beth Cameron, the National Security Council senior director for global health security and biodefense, is leaving her post this month after a year working in the Biden administration, according to three people with knowledge of the matter.

Cameron helped formulate President Joe Biden’s international strategy for fighting Covid-19 and worked intensively on the administration’s vaccine distribution across the world, POLITICO’s Erin Banco reports.

BIDEN TO TALK DRUG PRICES IN VIRGINIA — President Joe Biden will travel to Virginia on Thursday to discuss efforts by the government to lower prescription drug costs.

ARPA-H HEARING CLOUDED WITH LANDER COMPLAINTS — House lawmakers kicked off a Tuesday hearing on the president’s research agency proposal with talk of their missing guest — and what, if anything, it could mean for the Advanced Research Projects Agency for Health, Sarah reports.

Former White House science adviser Eric Lander’s late-night resignation following POLITICO reports of staff bullying meant the Energy and Commerce health subcommittee hearing went forward without the president’s biggest champion for the proposed $6.5 billion agency. While ARPA-H still has broad bipartisan backing, other witnesses — fielded questions about where the new health initiative should reside and how to measure its success.

The NIH battle continues. A growing number of lawmakers don’t want to see the agency housed at the National Institutes of Health despite many people thinking it was a foregone conclusion last year. That includes Republicans like Rep. Cathy McMorris Rodgers (Wash.), who used Lander’s resignation as evidence of bigger problems.

“I’m not convinced that a brand-new agency is the answer to or would be able to overcome the institutional, cultural and bureaucratic barriers that are present at our federal scientific agencies,” McMorris Rodgers said.

… POLITICO also reported Tuesday night that Lander publicly promoted Covid-19 vaccination efforts while having a significant financial investment in one of the vaccine makers, according to financial disclosures.

COUNTING CALIFF COMMITMENTS — FDA commissioner nominee Robert Califf continues to make the rounds to Senate offices, but Democrats’ hopes for scheduling a vote before the next recess seem to be fading, your morning host and Lauren report. Conversations with more than 30 senators Tuesday indicated not much has changed on the cardiologist’s prospects in the chamber: many Republicans and Democrats remain undecided.

Senate HELP Chair Patty Murray (D-Wash.) said she hopes to line up the vote during this work period, but that ends next week ahead of Presidents’ Day.

Meanwhile, some Republicans who previously backed Califf in 2016 continue to wrestle with their positions on the former FDA commissioner who backed agency staff decision-making on abortion pill mifepristone during his December confirmation hearing.

“It’s difficult when you vote for someone not to vote for him again, but there’s a lot of new information [that has] come up,” Sen. Chuck Grassley (R-Iowa) said. “I’ve got to consider that because I’m pro-life, you can’t talk out of both sides of your mouth.”

Senate GOP Whip John Thune said abortion remains a problem for him but added he hasn’t made up his mind. “I also know he’s going to be a lot better than some of the others they might nominate for that position, and that’s an argument that some of our pro-Califf members are making,” he said.

GOP LAWMAKERS ASK HHS, CMS TO JUSTIFY ALZHEIMER’S NCD — Seventy-eight House Republicans, including E&C ranking member McMorris Rodgers, sent a laundry list of questions to top Biden health officials Tuesday about a recent proposal that effectively limits Medicare coverage of Biogen’s Alzheimer’s disease drug Aduhelm to those in a clinical trial cleared by the Centers for Medicare and Medicaid Services.

“We are concerned that finalizing a decision to prohibit Medicare coverage for FDA approved [Alzheimer’s disease] treatments outside of government sanctioned randomized controlled trials could unnecessarily deny to patients and their families the hope of breakthrough AD treatments and further eroding Americans’ trust in their public health institutions,” the lawmakers wrote in their letter to HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure.

FIRST IN PULSE: SENATORS PRESS FDA TO MAINTAIN OTC HEARING AID PROPOSAL — A bipartisan group of 11 senators are urging the FDA to stick to its guns and maintain core components of its proposal to establish an over-the-counter hearing aid market in the US in its final rule .

The letter urges the agency to maintain federal preemption of state laws governing OTC products and its proposed maximum sound pressure level for the new hearing aid category. The hearing aid industry is lobbying the FDA to adopt a lower amplification level than it initially proposed.

“To ensure the final regulation is consistent with congressional intent, we urge the FDA to exclude any unnecessary restrictions that prevent access to OTC devices or limit their effectiveness for Americans with mild or moderate hearing loss,” the senators — which include Edge Paul (R-Ky.), Chris Van Hollen (D-Md.) and Marsha Blackburn (R-Tenn.) — wrote to acting FDA Commissioner Janet Woodcock.

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MERCK: 3.1M MOLNUPIRAVIR COURSES DELIVERED TO US GOVT — Pharmaceutical companies Merck and Ridgeback Biotherapeutics announced Tuesday they fulfilled an agreement to deliver about 3.1 million courses of the oral Covid antiviral molnupiravir — which received emergency use authorization from the FDA in December — to the US government.

HOSPITALS AGAIN ASK CONGRESS FOR MORE MONEY — In a letter sent to congressional leadership on Tuesday, more than a half-dozen hospital and allied groups, including America’s Essential Hospitals, the American Hospital Association, the Association of American Medical Colleges, are pressing Congress again for more resources to help offset the costs of the pandemic, Megan Wilson reports.

FEDERAL COURT UPHOLDS BIDEN’S FAMILY PLANNING RULE — A 3-judge panel at the 6th Circuit Court of Appeals rejected arguments on Tuesday by 11 GOP-controlled states that sought to block HHS’ rules for the Title X family planning program and reinstate Trump-era regulations banning abortion referrals.

Alice reports that the decision means, for now, the Biden administration can move forward on unwinding the conservative changes the Trump administration made to the Title X program, which provides free and subsidized contraception, STI tests and other services to millions of low-income people nationwide.

The new policy Biden unveiled last year is an attempt to return hundreds of Planned Parenthood clinics and other abortion providers to federal Title X network — providers that chose to leave rather than comply with Trump-era restrictions they considered a “gag rule.”

The federal judges that heard the case said they were not convinced that the states would suffer “irreparable harm” if Biden’s undoing of the Trump policy were allowed to proceed, and noted that several of the states had applied for family planning funding under the same Biden rules they were challenging in court.

What’s next: The group of red states, led by Ohio, is expected to appeal the case to the Supreme Court.

ONCE MORE, WITH FEELING — Do-over jury selection is slated to begin Wednesday in a federal class-action antitrust lawsuit against Sutter Health over accusations that the Sacramento-based hospital network abused its considerable market share, with opening statements set to start Thursday, POLITICO’s Victoria Colliver reports. Sutter Health officials have rejected the claims.

The Omicron surge delayed the Jan. 6 trial in the Northern District of California in San Francisco after a jury had been selected in December. The case, Sidibe v. Sutter Health, involves more than 3 million businesses and individuals who bought health insurance between 2006 and 2020. Damages could be as much as $1 billion.

In a separate antitrust case, the hospital network agreed to pay $575 million and adhere to a list of terms as part of a settlement finalized in August. The case was brought by a group representing self-funded employers and unions and California.

Phil Bongiorno is now senior vice president for advocacy and government relations for the American Academy of Physician Associates. He was most recently vice president for policy and government relations for the Academy of Managed Care Pharmacy.

Mohammed Sohail Chaudhry will be the FDA’s permanent chief technology officer. Chaudhry served at the agency in various capacities since 2015, most recently as acting CTO.

Johnson & Johnson temporarily paused production of its Covid-19 vaccine at a Dutch factory to manufacture a different vaccine, The New York Times’ Rebecca Robbins, Stephanie Nolen, Sharon LaFraniere and Noah Weiland report.

Travel nurses are earning more than double what they did before the Covid-19 pandemic due to gaps in hospital workforces, The Wall Street Journal’s Stephanie Armor and Robbie Whelan report.

Amazon’s telehealth service is rolling out nationwide, CNBC’s Annie Palmer and Bertha Coombs report. The conglomerate plans to expand its in-person Amazon Care offerings to more than 20 cities later this year.

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

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