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Presented by CVS Health: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | |  | | By Lauren Gardner, David Lim and Katherine Ellen Foley | Presented by CVS Health | | | | — The Senate Health Committee will mark up bipartisan pandemic preparedness legislation today. — Pfizer’s CEO says a fourth Covid-19 vaccine dose will be needed, getting ahead of federal scientists on the booster issue. — FDA’s top tobacco regulators give an office update at a meeting of the minds for top tobacco researchers. It’s Tuesday. Welcome back to Prescription Pulse. This time next week, we’ll officially have more daylight here than darkness — a welcome change of pace, if you ask us. Send tips, feedback and spring equinox celebrations to David Lim (dlim@politico.com or @davidalim), Lauren Gardner (lgardner@politico.com or @Gardner_LM ) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley).
| | A message from CVS Health: Throughout the pandemic, in communities across the country, CVS Health has been there. We’ve opened more than 4,800 COVID-19 test sites, administered 41 million tests and given 59 million vaccines. We’ve expanded access to prenatal and postpartum care via telemedicine, increased remote access to mental health services and invested in affordable housing to help build healthier communities. We’ve been on the frontlines, making health care easier to access and afford. Learn more. | | | | | | SENATE HELP MEMBERS TEE UP PANDEMIC PREP AMENDMENT WINS — The Senate HELP Committee kicks off its markup of pandemic preparedness legislation, S. 3799 , at 10 a.m. In the last week, some panel members introduced bipartisan bills with provisions they managed to have included in the underlying text: Preparedness centers: A measure led by Sen. Roger Marshall (R-Kan.) would give CDC authority to issue grants to higher education institutions or other private entities to establish “centers for public health preparedness and response,” a proactive network to improve and unify public health communication during an emergency. Biosurveillance and forecasting: The bill also includes a decent chunk of a measure by Sens. John Hickenlooper (D-Colo.) and Bill Cassidy (R-La.) to modernize and formalize CDC programs that focus on surveillance and infectious disease forecasting. A committee aide said to expect Chair Patty Murray (D-Wash.) to offer her bill with ranking member Richard Burr (R-N.C.) to establish the Advanced Research Projects Agency for Health, or ARPA-H, as an amendment, too. Some Republican-led efforts could also get airtime during the meeting. The fire Fauci amendment: Sen. Rand Paul (R-Ky.) has drafted an amendment to eliminate Anthony Fauci’s position as head of the National Institute of Allergy and Infectious Diseases, split the agency into three distinct institutes and make their directors Senate-confirmable and subject to five-year terms. Another possible GOP amendment contender is a bill by Marshall and Sen. Mike Braun of Indiana that would require the Government Accountability Office to report on the current scientific understanding of the duration and effectiveness of Covid-19 immunity acquired from infection, vaccination or both.
| | | | SUBSCRIBE TO NATIONAL SECURITY DAILY : Keep up with the latest critical developments from Ukraine and across Europe in our daily newsletter, National Security Daily. The Russian invasion of Ukraine could disrupt the established world order and result in a refugee crisis, increased cyberattacks, rising energy costs and additional disruption to global supply chains. Go inside the top national security and foreign-policymaking shops for insight on the global threats faced by the U.S. and its allies and what actions world leaders are taking to address them. Subscribe today. | | | | | | | | PFIZER’S BOURLA ASSERTS A FOURTH DOSE WILL BE NEEDED — Pfizer’s chief executive said Sunday that another Covid-19 booster shot would be needed, voicing support for a fourth vaccine dose before FDA has determined whether such a broad recommendation is warranted, POLITICO’s Maeve Sheehey reports. The company is in the process of submitting data on a fourth dose to FDA, he added. “I think right now we need to be very well-coordinated — CDC, FDA and the industry — so that we are all providing to the American people and to the world a cohesive picture rather than confusion,” Pfizer CEO Albert Bourla said on CBS’ Face the Nation. Pfizer pledged on Monday to donate profits from its Russian subsidiary to “causes that provide direct humanitarian support to the people of Ukraine.” “Pfizer concluded that a voluntary pause in the flow of our medicines to Russia would be in direct violation of our foundational principle of putting patients first,” the company said in a statement. “Ending delivery of medicines, including cancer or cardiovascular therapies, would cause significant patient suffering and potential loss of life, particularly among children and elderly people.” But the company also said it will no longer start new clinical trials in Russia and plans to stop recruiting new patients into its ongoing trials currently being conducted in the nation. A CDC study released Friday showed Pfizer’s shot was moderately effective against the Omicron variant in young children ages 5 to 11. The study looked at 1,364 children who were tested weekly in Arizona, Texas, Florida and Utah between July 2021 and February 2022, regardless of their symptoms. Two doses of the Pfizer-BioNTech vaccine reduced the infection risk by 31 percent in kids 5 to 11 years old and 59 percent in those 12 to 15 years old, POLITICO’s Krista Mahr reports.
| | | |   | | | | | | TOBACCO REGULATORS HEAD TO BALTIMORE FOR RESEARCH CONFERENCE — The Food and Drug Administration’s top tobacco regulators head to Baltimore today for the annual meeting of the Society for Research on Nicotine and Tobacco, Katherine reports. The four-day gathering is a meeting of the minds in nicotine and tobacco research and has a strict “no industry” policy: No one with ties to major tobacco companies can become a member or attend the meeting, nor does the group take funding from the tobacco or e-cigarette industry. (Employees of e-cigarette companies without any relationship to tobacco companies are the exception, as are those who consult for tobacco companies, pending additional review.) Mitch Zeller, the current head of FDA’s Center for Tobacco Products; Benjamin Apelberg, the deputy director for regulatory science in CTP’s Office of Science, and Kathleen Crosby, the director of CTP’s Office of Health Communication and Education, will be speaking. They’re slated to discuss issues Congress is keyed into, including progress on the premarket tobacco application process for major e-cigarette companies (now more than six months past its deadline, for those of you counting) and the regulatory challenges posed by synthetic nicotine. Though lawmakers granted CTP the ability to regulate synthetic nicotine last week, it’s unclear how that authority and enforcement will look in practice. The meeting will be one of Zeller’s last appearances as CTP director: He is slated to step down in April. Meanwhile, members of the tobacco industry meet with the White House’s budget office: Through the end of this month, industry group lobbyists have several scheduled meetings with the Executive branch’s regulatory offices to discuss the rules that would ban menthol cigarettes and cigars. A handful of nicotine cessation public health groups are also meeting with these offices. And the Federal Trade Commission preps to talk about e-cigs: The group is scheduled to meet Thursday at 1 p.m. to talk about youth vape use.
| | | CDC PLANS TO MONITOR SEWAGE GETS STUCK IN THE MUD — The pandemic inspired federal health officials to launch a National Wastewater Surveillance System to detect public health threats but are having trouble roping in states , Katherine and POLITICO’s Megan Messerly report. The White House has touted the network as part of its pandemic preparedness strategy. But without robust participation and sustained funding, the network risks falling apart. “If you enjoyed the way this pandemic worked, you can expect to have that again,” said Ted Smith, the director of the Center for Healthy Air, Water and Soil at the University of Louisville’s Environment Institute. “That’s what’s at stake here.”
| | | | DON’T MISS POLITICO’S INAUGURAL HEALTH CARE SUMMIT ON 3/31: Join POLITICO for a discussion with health care providers, policymakers, federal regulators, patient representatives, and industry leaders to better understand the latest policy and industry solutions in place as we enter year three of the pandemic. Panelists will discuss the latest proposals to overcome long-standing health care challenges in the U.S., such as expanding access to care, affordability, and prescription drug prices. REGISTER HERE. | | | | | | | | FIRST HIV VAX DOSE ADMINISTERED IN MODERNA TRIAL — Moderna said Monday that it has dosed the first participant in a Phase I clinical trial of its experimental HIV trimer mRNA vaccine. The trial, sponsored by the National Institute of Allergy and Infectious Diseases’ AIDS division, will test three experimental vaccines for safety and immune responses.
| | | Emergent BioSolutions announced it is adding Coleen Glessner as executive vice president on global quality, ethics and compliance and Bill Hartzel as its lead on compliance and contract development and manufacturing. iRhythm Technologies announced Kevin King is retiring from its board of directors effective April 1. He previously served as the company’s chief executive officer. Illumina added Carissa Rollins as its new chief information officer. She previously worked for UnitedHealthcare as its chief information officer. Margarita Valdez is now the director of policy and advocacy at the American Society of Gene & Cell Therapy. She previously was assistant director of congressional relations at the American Society for Radiation Oncology. Ropes & Gray has added David Ault as counsel. He previously worked at Faegre Drinker and the Centers for Medicare and Medicaid Services.
| | | The Covid pandemic has spurred another public health crisis in sexually transmitted infections, but the campaign to prescribe pre-exposure prophylaxis, or PrEP, to more people at risk for contracting HIV is flagging, POLITICO’s Alice Miranda Ollstein reports. Now-former New York City health commissioner Dave Chokshi discusses the city’s Covid-19 response in an interview with The New York Times' Emma G. Fitzsimmons.
| | | FDA published fiscal year 2022 fee rates for its over-the-counter monograph drug user fee program on Monday. The Department of Transportation will hold a virtual meeting on Thursday, March 24, to learn about the difficulties people who use wheelchairs face when flying.
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