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Presented by PhRMA: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy. | | | | | |  | | By Lauren Gardner | | | With help from Alice Miranda Ollstein, Erin Banco 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. | | | — The Biden administration likely will move one step closer Thursday to having a permanent FDA commissioner. — President Joe Biden gives another Covid-19 speech as hospitalizations spike. — HHS sent Congress three user fee agreements to fund FDA programs on Wednesday. WELCOME TO THURSDAY PULSE — This FDA reporter can’t help but wonder how the French will respond to news of the agency revoking the eponymous salad dressing’s “standard of identity” — when there’s no way they’d eat the orange goo Americans know and love. Have we met? Let’s get acquainted: lgardner@politico.com or on Twitter @Gardner_LM. | | | | A message from PhRMA: Did you know more than half of every dollar spent on medicines goes to someone who doesn’t make them? There’s a long line of middlemen, like PBMs and insurers, collecting a significant portion of what you pay for medicine. The share of total spending for brand medicines received by the supply chain and other stakeholders increased from 33% in 2013 to 50.5% in 2020. Learn more. | | | | | | SENATE PANEL VOTES ON FDA NOMINATION — The Senate HELP Committee will vote this morning on whether to advance Robert Califf’s nomination to helm the FDA for a second time. As your morning host and her FDA team colleagues have reported, the cardiologist appears likely to return to the Silver Spring, Md., campus thanks to support from committee Republicans. The prospect of needing GOP votes grew more evident Tuesday when Sen. Maggie Hassan (D-N.H.) said she would oppose Califf over concerns that he’d maintain the opioid labeling status quo at the agency. “New Hampshire has been hit especially hard by the substance misuse epidemic and it is imperative that we have a strong FDA Commissioner in place who recognizes the role that the agency’s decisions played in fueling this crisis,” she said in a statement. “After careful review of Dr. Califf’s record, including questioning him during last month’s nomination hearing, it does not appear that things would be different under his leadership and I will be voting no on his nomination.” But with committee colleague Bernie Sanders (I-Vt.) already a “no” vote, Chair Patty Murray (D-Wash.) will need at least three Republicans — and maybe more, if other publicly undecided Dems opt to vote no — to back Califf to avoid a tie in the evenly split panel. Based on our post-nomination hearing stakeout, she should have sufficient support across the aisle. BIDEN TO HIGHLIGHT MILITARY SURGE TO HOSPITALS AMID COVID SPIKE — The president this morning will spotlight deployments of military medical personnel to six states during his latest pandemic response speech. The first 1,000 service members helping with the surge effort will land at hospitals next week, a White House official said in advance of the address. Defense Secretary Lloyd Austin and FEMA Administrator Deanne Criswell will attend. The next deployments will cover six states: New York, New Jersey, Ohio, Rhode Island, Michigan and New Mexico. The military medical teams will help relieve frontline staff overwhelmed by Covid cases, triage patients and give hospital staff the ability to provide other care. “Teams will continue to be mobilized and deployed where they are needed over the coming weeks to confront Omicron,” the official said. | | | | STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today. | | | | | | | | HHS SENDS USER FEE AGREEMENTS TO CONGRESS — HHS on Wednesday transmitted to Congress three user fee packages — negotiated agreements between FDA and industry — for Prescription Drug User Fee Act VII, Generic Drug User Fee Amendments III and Biosimilar User Fee Amendments III, both a source familiar with the process and a congressional aide told David. The action represents the latest step toward a potential five-year reauthorization of the so-called must-pass legislation,which dictates programs where industry pays fees to the FDA in exchange for commitments to conduct timely reviews of medical products. An FDA spokesperson said details about the fifth iteration of the Medical Device User Fee Amendments will be released when negotiations with the device industry are finalized. “In order to respect the negotiation process, we cannot comment on any specific details,” the spokesperson said. DEMS PUSH BILLS TO GIVE ALL AMERICANS FREE MASKS AND TESTS — Two bills Democrats introduced Wednesday would compel the federal government to send free N95 masks and rapid tests to all American residents, a progressive push amid mounting frustrations with the Biden administration’s response to the Omicron surge, Alice reports. One bill, championed by Sanders in the Senate and Ro Khanna (D-Calif.) in the House, would spend $5 billion for the Postal Service to deliver three N95 masks to each person in the U.S., with additional distribution at schools, public transportation stations and other sites. The lawmakers first introduced the measure in 2020, and they argue it’s more urgent than ever as Omicron drives record hospitalizations. While the Biden administration is facing calls to authorize mass mask distribution, some officials oppose it, with one official arguing that “half the country won’t wear any mask.” “That’s like saying, ‘There are so many people who won’t get vaccinated, so why provide vaccines?’” a frustrated Khanna told Alice. “Even if it’s just for the people willing to wear it, that would make a huge dent in cases.” Another bill from Reps. Don Beyer (D-Va.), Dina Titus (D-Nev.), Joe Morelle (D-N.Y.) and Kai Kahele (D-Hawaii) would have the government send two rapid at-home tests a week to every U.S. resident for a year. The bill would authorize the government to spend as much as needed to make that happen but doesn’t include a cost estimate. Its sponsors said they can’t estimate the price tag, as such a mass purchase by the government could meaningfully lower current test costs. | | | | A message from PhRMA:   | | | | | | NOVAVAX SPEAKS OUT ON MANUFACTURING PROBLEMS — Over the past four months, POLITICO’s Erin Banco, Sarah Owermohle and Adam Cancryn have reported on the manufacturing issues inside Novavax’s U.S. facilities. In October, they detailed for the first time how the company has struggled to produce a high-quality Covid-19 shot in large batches. Novavax has refrained from discussing its manufacturing problems openly — until now. In a recent interview with Yahoo Finance, John Trizzino, Novavax’s chief commercial officer, said the company’s product is difficult to make. “It’s a complicated assay, and we underestimated what it would take to develop those assays,” he said. Despite its difficulties with manufacturing in the U.S., the Maryland-based company has won authorization for its shot in Indonesia and Europe. The World Health Organization has also authorized the Novavax vaccine, which involves infecting the cells to produce spike proteins. The vaccine could help significantly in the global campaign to vaccinate 70 percent of the world’s population by July — as long as it continues to receive regulatory allowances. As POLITICO revealed last month , Novavax used manufacturing data from only the Serum Institute of India to apply for its current authorizations, raising questions about its capabilities at its U.S. and European facilities. Trizzino told Yahoo Finance this week that the company also chose to submit data from Serum for its application with the FDA. He didn’t elaborate on why Novavax didn’t submit manufacturing data from its U.S. sites but said “it would be Serum product that we would use in the U.S.” A class-action lawsuit against Novavax alleges its executives made misleading statements about the extent of the company’s manufacturing issues and the time it would take to gain regulatory approval for its vaccine. MODERNA: KID VACCINE DATA EXPECTED IN MARCH — Moderna said Wednesday that it expects to report trial data on its Covid vaccine in children ages 2 to 5 by March. “If the data is supportive and subject to regulatory consultation, Moderna may proceed with regulatory filings for children 2–5 years of age thereafter,” it said in a statement. The update came as parents of kids under 5 grow more exasperated at the lack of inoculation options for the age group, which has seen record hospitalization rates with Omicron’s rise. A lead doctor at one trial site reportedly said Moderna had been asked to add even more children to its 4-and-under study group, in addition to the FDA’s summertime request for larger pediatric trials. | | | | BECOME A GLOBAL INSIDER: The world is more connected than ever. It has never been more essential to identify, unpack and analyze important news, trends and decisions shaping our future — and we’ve got you covered! Every Monday, Wednesday and Friday, Global Insider author Ryan Heath navigates the global news maze and connects you to power players and events changing our world. Don’t miss out on this influential global community. Subscribe now. | | | | | | | | CDC ESTIMATES 101K DRUG OVERDOSE DEATHS OVER A YEAR — Provisional data the CDC released Wednesday predicts that 101,263 Americans died of drug overdoses in the 12-month period ending in June 2021. That’s a 3.3 percent increase over the 98,022 deaths already reported. “Behind these numbers are family members, friends, and neighbors whose lives have been claimed by an overdose epidemic being driven by fentanyl,” Rahul Gupta, director of the White House Office of National Drug Control Policy, said in a statement. “We must meet this moment with the urgency it deserves by working together at the federal, state, and local level to quickly expand access to evidence-based harm reduction services … and remove barriers to treatment, prevention, and recovery support services.” | | | Amy Pellegrino is now a director on Johnson & Johnson’s federal affairs pharmaceutical team, overseeing part of the Janssen Pharmaceuticals portfolio. She most recently was health policy director for Sen. Susan Collins (R-Maine). Sanofi has tapped Jenn Dale as a senior director for federal government relations. She was most recently a lobbyist for GlaxoSmithKline and previously worked for Rep. Mike Thompson (D-Calif.). | | | It doesn’t matter whether you’re hospitalized “for” Covid or “with” Covid — America’s hospital system is buckling under the sheer volume of patients, The Atlantic’s Ed Yong writes. The president of Biogen, whose controversial Alzheimer’s drug is set to receive limited Medicare coverage, plans to flood regulators with comments in hopes of ensuring changes to the final decision, Endpoints News writes. The Biden administration’s plan to send 500 million free Covid rapid tests to Americans will take weeks or months to pull off based on new contracts and interviews with test makers, ABC News reports. | | | | A message from PhRMA: Did you know that PBMs, hospitals, the government, insurers, and others received a larger share of total spending on medicines than biopharmaceutical companies? That’s right, more than half of spending on brand medicines goes to someone who doesn’t make them. Let’s fix the system the right way and ensure more of the savings go to patients, not middlemen. Read the new report. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
