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Presented by Coalition to Protect America’s Health Care: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | |  | | By Lauren Gardner, Katherine Ellen Foley and David Lim | | | With help from Megan R. Wilson
| | CDC ADVISERS CONSIDER MATERNAL RSV VACCINES — The CDC’s vaccine advisory committee will meet today to deliberate who should receive Pfizer’s maternal RSV vaccine, which gained the greenlight from FDA in August to provide infants with additional protection from the virus. Should advisers recommend the shot — and CDC Director Mandy Cohen endorse the recommendation — the vaccine would be the second tool available to protect infants against RSV, which leads to as many as 80,000 hospitalizations and as many as 300 deaths of children under age 5 per year. Earlier this year, CDC advisers also recommended a monoclonal antibody from Sanofi and AstraZeneca for infants and some toddlers.
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Medical personnel vaccinate students at a school in New Orleans on Jan. 25, 2022. | Ted Jackson/AP Photo | Who should get what shot? The maternal vaccine may be easier to distribute. “We already give other vaccines in pregnancy,” Dr. Flor Muñoz-Rivas, an associate professor of pediatrics and infectious disease at the Baylor College of Medicine, told Prescription Pulse. “This is just adding one more for this season.” But some pregnant people may not get vaccinated if they miss their window. The FDA approved Pfizer’s shot to be administered between 32 and 36 weeks of pregnancy, which should allow at least a month for them to develop antibodies. Individuals who aren’t able to get to a health care provider at that time — or whose babies are born less than a month after getting the shot — won’t be able to pass on full protection. Beyfortus, the monoclonal antibody, is an ideal alternative for these babies, Dr. Muñoz-Rivas said. But the rollout may be tricker. “Most hospitals are not ready” to distribute the shot to newborns, she said, noting that the process of billing for patients on public and private insurance can complicate the process. Pediatric practices would need to establish billing processes to provide the shot. Spokespeople from Pfizer and Sanofi said they have begun distributing their products in the U.S. but declined to specify how many would be reaching hospitals, pharmacies and other health care settings. Some infants may also be able to receive a combination of both shots. CDC advisers plan to hear information about which children may be candidates for both, according to the meeting agenda. IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Have you had trouble finding updated Covid vaccines? Let us know. Send news and tips to Lauren Gardner (lgardner@politico.com or @Gardner_LM), David Lim (dlim@politico.com or @davidalim) and Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Alice Miranda Ollstein talks with POLITICO reporter Sally Goldenberg about how former President Donald Trump’s zigzagging on abortion policy is causing turmoil in the anti-abortion movement and shaking up the GOP presidential primary.
| | | | A message from Coalition to Protect America’s Health Care: America’s hospitals have been pushed to the brink by broken supply chains, workforce shortages, and high inflation. Now, some in Congress want to reduce hundreds of billions of dollars in funding, jeopardizing patient access to quality care, especially in underserved communities. Congress: protect patient access to 24/7 hospital care. | | | | | GRIFFITH FLOATS ALT MEDICARE COMPETITION IDEA — Rep. Morgan Griffith (R-Va.) is not shy about his opinion that the Biden administration’s Medicare drug price negotiations are unconstitutional. But he wants you to know he supports allowing Medicare to negotiate under the right circumstances. “You should have that opportunity to negotiate, you just shouldn’t do it with strong arm tactics,” Griffith said.
|  Subcommittee Chair Morgan Griffith (R-Va.) speaks during a House Energy and Commerce Subcommittee on Oversight and Investigations and the Subcommittee on Health hearing about the federal response to the coronavirus pandemic on Capitol Hill, on Feb. 8, 2023. | Drew Angerer/Getty Images | Lowering the price of drugs is personal, Griffith says. The lawmaker takes Janssen’s Xarelto — one of the first 10 drugs selected for Medicare negotiations — a medicine he says is necessary to do his job. Between June 2022 and May, 1,337,000 Medicare Part D enrollees took the drug at a cost of more than $6 billion, according to CMS. “My blood clotting was triggered by Covid,” Griffith said. “I would have had to leave Congress — my district is bigger than nine states by landmass now — and you can’t drive all those miles.” Competitive bidding? Instead of penalizing firms for not participating in the program established by the Inflation Reduction Act, Griffith said he would support establishing a competitive bidding process. If two drugs treat the same condition, Medicare should be able to ask each firm which can provide it at the cheapest price. “We’re going to take your bid on a certain date, tell us what your lowest price is,” Griffith said. “That’s real negotiation.”
| | | | HAPPENING 9/28 — INSIDE THE CANCER MOONSHOT: Join POLITICO on Thursday, Sept. 28 for an in-depth discussion on the future of cancer treatment and innovation. Hear from experts including scientists, government officials and industry leaders as we explore the critical roles played by private industry, nonprofits, the National Cancer Institute and the new Advanced Research Projects Agency for Health in achieving the Biden administration's goal of cutting the cancer death rate in half over the next 25 years. Don't miss this opportunity to dive into the progress of cancer treatments and learn about the challenges patients encounter in accessing care. REGISTER HERE. | | | | | PRIMARY CARE BILL MOVES THROUGH HELP — The Senate HELP Committee on Thursday advanced a package aimed at bolstering primary care access in a 14-7 vote, despite conflict between committee leaders, POLITICO’s Megan R. Wilson reports. The $26 billion package, introduced by Chair Bernie Sanders (I-Vt.) and Sen. Roger Marshall (R-Kan.), budgets billions in funding for community health centers and to bolster the doctor, nursing and dentist workforces. Three Republicans — Marshall and Sens. Mike Braun (Ind.) and Lisa Murkowski (Alaska) — voted with Democrats to approve the bill. Push and pull: Sanders argued that health worker shortages have hurt access to care. Ranking member Bill Cassidy (R-La.) pushed back against the legislation, saying it lacked provisions to offset costs. “We're working on a new proposal six legislative days before the program expires. We have no time to align with our House counterparts, guaranteeing that we'll have to do a short term, flat-funded patch,” he said. Hospitals have expressed opposition to the bill. Following the markup, the Federation of American Hospitals said that some of the provisions would threaten patients' access to care. “Funding for community health centers and workforce programs is desperately needed, but it is a travesty to fund them at the expense of essential patient care. Robbing Peter to pay Paul is no way to ensure health care for America’s most vulnerable," said Chip Kahn, the group's CEO. Bottomline: The package isn’t likely to pass the Republican-controlled House, but it is significant because it marks the Senate’s negotiating position in reauthorizing several programs that expire on Sept. 30.
| | | | A message from Coalition to Protect America’s Health Care:   | | | | | CALIFF’S GLOBAL TOUR — FDA Commissioner Robert Califf is in India this week meeting with top health officials, including Shri Sudhansh Pant, India’s secretary of the Ministry of Health & Family Welfare, and Ministry of Ayush Secretary Vaidya Rajesh Kotecha. A readout from the Ministry of Health posted on X, the platform formerly known as Twitter, said the U.S. agreed to work with India on IT infrastructure, food inspector training and knowledge sharing. “We work closely with the Ministry and agencies within the Ministry on food and medical product safety,” Califf posted on X. “I’m excited to continue this important relationship.” Califf was in Singapore earlier this week, where he met with his counterpart at the Health Sciences Authority about international standards on health products and medicines. “The FDA sought to strengthen its engagement in that region and to identify new opportunities to collaborate with government and non-government partners on regulatory issues such as the international standards, translational research and evidence generation,” spokesperson Audra Harrison said of the Singapore trip. FDA FOUNDATION TO ISSUE MISINFORMATION REPORT — The Reagan-Udall Foundation plans to release a commissioner-requested report on Oct. 5 — as long as the federal government doesn’t shut down — outlining how the FDA can more effectively combat misinformation, the group’s leader said this week. “In a way, he’s looking for a magic wand, and we did not find one,” Susan Winckler, the organization’s CEO, said on Tuesday of FDA leader Robert Califf at the Consumer Healthcare Products Association’s annual conference. The report will offer strategies and tactics for the FDA to consider while making information more accessible to the public. “That game of whack-a-mole” — trying to correct misinformation in real-time — “that is difficult, and it probably doesn’t work well,” Winckler said.
| | | | GO INSIDE THE CAPITOL DOME: From the outset, POLITICO has been your eyes and ears on Capitol Hill, providing the most thorough Congress coverage — from political characters and emerging leaders to leadership squabbles and policy nuggets during committee markups and hearings. We're stepping up our game to ensure you’re fully informed on every key detail inside the Capitol Dome, all day, every day. Start your day with Playbook AM, refuel at midday with our Playbook PM halftime report and enrich your evening discussions with Huddle. Plus, stay updated with real-time buzz all day through our brand new Inside Congress Live feature. Learn more and subscribe here. | | | | | | | | PhRMA FILLS TOP LOBBYIST SPOT — Steve Tilton, the lead lobbyist for Takeda, is having a homecoming. The Pharmaceutical Research and Manufacturers of America has named him as its new head of federal advocacy, Megan reports. Tilton, who has worked in PhRMA's lobby shop twice before, is a consequential hire for the group as it fights to regain its footing after the industry’s biggest legislative loss in decades with the passage of the Inflation Reduction Act. The drugmakers' most powerful lobbying group has lost three member companies — AbbVie, AstraZeneca and Teva Pharmaceuticals — since last December. He replaces Anne Esposito, who stepped down as the head of PhRMA’s federal advocacy in August. Tilton is a longtime pharma advocate and is a House Energy and Commerce Committee alum.
| | An HHS Office of Inspector General report said the FDA could do more to penalize tobacco retailers with a history of selling products to children. The FDA published final guidance on how clinical trials should be conducted if they are disrupted by disasters and public health emergencies. The FDA published draft guidance on formal meetings between the agency and drugmakers. The FDA published draft guidance on alternative ways to assess drug manufacturing facilities listed on pending applications.
| | | | A message from Coalition to Protect America’s Health Care: Broken supply chains. Workforce shortages. High inflation. America’s hospitals have been pushed to the brink. More than 100 rural hospitals have already closed and many more are operating in the red. So why do some in Congress want to reduce hundreds of billions of dollars in funding for patient care – jeopardizing patient access to quality care, especially in underserved communities? Tell Congress: no funding cuts to care. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
