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 somebody 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 U.S. 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 hinder access to OTC devices or limit their effectiveness for Americans with mild or moderate hearing loss,” the senators — which include Rand Paul (R-Ky.), Chris Van Hollen (D-Md.) and Marsha Blackburn (R-Tenn.) — wrote to acting FDA Commissioner Janet Woodcock.
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