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Presented by The Pharmaceutical Care Management Association: 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 The Pharmaceutical Care Management Association | With Alice Miranda Ollstein
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A health care worker fills a syringe with the Pfizer Covid-19 vaccine at Jackson Memorial Hospital on Oct. 5, 2021, in Miami. | Lynne Sladky/AP Photo | UPDATED COVID SHOTS ON DECK FOR BABIES, TODDLERS — The CDC could endorse Covid-19 shots updated to target two Omicron subvariants as soon as today for children under 6. The agency is slated to host a call this morning with outside public health groups to discuss the expected rollout. The FDA updated emergency use authorizations for Pfizer-BioNTech’s and Moderna’s vaccines on Thursday to allow children under 5 and under 6, respectively, to receive the bivalent formula as their third shots. The CDC’s vaccine advisers had been scheduled to meet today, but the event —for which no agenda had been published — was postponed. The FDA’s own external advisers weren’t convened to weigh in on the issue. “I think these decisions should be vetted through advisory committees,” vaccine adviser Paul Offit of the Children’s Hospital of Philadelphia said. The details: Since Moderna’s primary series for kids 6 months through 5 years is two doses, they may receive a bivalent booster two months after the initial series. For children under 5 who have yet to complete their three-dose Pfizer primary series, they’d receive the bivalent formula as their third shot. Those who have already completed that series won’t yet be eligible for the bivalent dose, as supporting data for those children aren’t expected until January. It’s Friday. Welcome to Prescription Pulse. As one lobbyist told us this week, Congress is like “a one-legged duck” who’s “swimming in circles.” Happy holidays. Send tips, feedback and merriment 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 ). Today in our Pulse Check podcast , retiring Rep. Fred Upton (R-Mich.) joined Ruth to talk about his years of health care work on the Energy and Commerce Committee. And Upton urged colleagues to pass an updated version of his 21st Century Cures Act as well as the PASTEUR Act to spur the creation of new antibiotics. Later, John Halamka of the Mayo Clinic Platform talks about the future of AI in health care.
| | | | | | | A message from The Pharmaceutical Care Management Association: During Diabetes Awareness Month, America’s pharmacy benefit managers, PBMs, continue their specialized work helping diabetes patients take their drugs safely and affordably. With a PBM on her side, Kaeana’s daughter, who lives with diabetes and a rare liver condition, gets her medications for $40 - not the $6,000 these prescription drugs would otherwise cost her. Hear Kaeana’s Story. Learn more about how PBMs are working on behalf of all Americans living with diabetes. | | | | | | FDA RIDER WATCH — Senate HELP Committee Ranking Member Richard Burr told reporters on Wednesday that if Congress moves forward with a longer-term continuing resolution, the likelihood of health care legislation hitching a ride will significantly diminish. “CRs typically don't get out of the institution easily unless they're clean,” Burr said. “So I think what everyone needs to remember is that there may be some policy things that will have to go back through the process." House Energy and Commerce Chair Frank Pallone (D-N.J.) said Thursday that Democrats are still pushing to include proposed FDA measures regardless of the funding vehicle. “I’m trying to get these provisions on there — I obviously want an omnibus — but we will try to get them on whatever the vehicle is,” Pallone said of his efforts that include legislation to reform regulation of laboratory developed tests and diagnostics. “We’re trying to get the VALID Act, we’re trying to get all the things that were in the original FDA authorization.” Not dead yet: Senate Majority Whip Dick Durbin (D-Ill.) and the Council for Responsible Nutrition are trying to revive talks with Senate HELP Chair Patty Murray (D-Wash.) and tinkering with legislative language on dietary supplements to assuage lawmakers' concerns and garner support to attach the bill to a vehicle. “We’re trying to find common ground that will help this get advanced,” said Council for Responsible Nutrition spokesperson Craig Muckle. For your radar: Despite what some lawmakers had hoped, legislation to create a subscription model for new antimicrobial drugs that fight drug-resistant bugs didn’t make it into the fiscal 2023 defense authorization bill the House passed this week. SANDERS PUTS PHARMA ON NOTICE — Sen. Bernie Sanders (I-Vt.) told reporters on Thursday that having subpoena power next Congress as chair of the Senate HELP Committee will enhance his ability to scrutinize the insurance and pharmaceutical industries. “We are and will be prepared to take on very powerful special interests,” Sanders told reporters on Thursday. “We pay twice as much per capita as other countries for health care, we pay the highest prices in the world for prescription drugs ... I think there’s a lot to look at in those areas.”
| | | | POLITICO AT CES 2023 : We are bringing a special edition of our Digital Future Daily newsletter to Las Vegas to cover CES 2023. The newsletter will take you inside the largest and most influential technology event on the planet, featuring every major and emerging industry in the technology ecosystem gathered in one place. The newsletter runs from Jan. 5-7 and will focus on the public policy related aspects of the event. Sign up today to receive exclusive coverage of CES 2023. | | | | | | | | OFFICE OF NATIONAL DRUG CONTROL POLICY UNVEILS OVERDOSE DASHBOARD — The Biden administration launched a national dashboard Thursday that, for the first time, tracks nonfatal overdoses in near real-time and offers a new window into a poorly understood aspect of the opioid crisis, POLITICO’s Krista Mahr reports. Nonfatal overdoses are a good predictor of fatal overdoses. By monitoring trends in nonfatal overdoses, the new dashboard could help public health officials intervene before fatalities surge by allocating more naloxone, the drug used to reverse an overdose, to addiction services in counties requesting it.
| | | REPORT CITES ‘CONSTANT TURMOIL’ IN FDA’S FOOD PROGRAM — An independent evaluation of the the FDA’s food safety operations found that the program lacks leadership and mission clarity , POLITICO’s Marcia Brown reports. The result is slow decision-making and weak regulation of foodborne illness. In response to the report, the FDA said in a statement that it plans to release an update on a “new vision” in January and any changes to leadership as well as processes and procedures by February. In July, the FDA commissioned the expert panel, chaired by former FDA Commissioner Jane Henney, at the non-profit Reagan-Udall Foundation, to review the Human Foods Program, in part due to widespread outrage about the ongoing infant formula crisis. FDA Commissioner Robert Califf acknowledged on Wednesday that “there were issues on the food side of the FDA,” at the Milken Institute Future of Health Summit , but said changes he wanted to make upon his confirmation had to be put on hold during the Abbott infant formula recall. OIG FINDS FDA'S ONLINE TOBACCO RETAILER OVERSIGHT ‘NEEDS IMPROVEMENT‘ — HHS‘ Office of the Inspector General said this week that the FDA's ability to prevent youth access to tobacco products online “needs improvement,” Katherine reports. OIG reviewed the agency’s online enforcement actions from 2010 and 2020, which included nothing more than warning letters to a sliver of operating retailers flagged for review, and recommended that moving forward, the FDA partner more effectively with the Bureau of Alcohol, Tobacco and Firearms to monitor online retailer activity, among other guidance.
| | | | A message from The Pharmaceutical Care Management Association:   | | | | | | PFIZER RECEIVES PRIORITY REVIEW FOR RSV VACCINE FOR OLDER ADULTS — The FDA granted priority review to Pfizer's application to approve its respiratory syncytial virus vaccine for adults 60 and older, Katherine reports. Under priority review, the FDA shortens the time it takes to evaluate applications by four months; it should have a decision by no later than May 2023. According to the company, the vaccine was nearly 86 percent effective at preventing lower-respiratory tract infections of RSV in adults 60 and older. While RSV cases are more common in children under 5 years, more hospitalizations from RSV occur among the elderly. There are no RSV vaccines for any age group currently available. EMERGENT BIOSOLUTIONS SEEKS OTC OVERDOSE DRUG APPROVAL — The FDA has granted priority review to Emergent BioSolution’s application for a non-prescription version of Narcan, a nasal spray version of the overdose reversal drug naloxone, Katherine reports. At the moment, all forms of naloxone require a prescription. The FDA will make a decision on the application by March 29.
| | | | POLITICO APP USERS: UPGRADE YOUR APP BY DECEMBER 19! We recently upgraded the POLITICO app with a fresh look and improved features for easier access to POLITICO's scoops and groundbreaking reporting. Starting December 19, users will no longer have access to the previous version of the app. Update your app today to stay on top of essential political news, insights, and analysis from the best journalists in the business. UPDATE iOS APP – UPDATE ANDROID APP . | | | | | | | | Brad Miller will become Moderna’s chief information officer in 2023. He joins the company from Capital One. Susan Askew is now PAC and political advocacy director at AdvaMed. She was most recently executive director of ICSC PAC, the political action committee for the International Council of Shopping Centers.
| | | The FDA published draft guidance for medical device manufacturers on voluntarily reporting malfunctions and on the content of human factors information in new product applications.
| | | | A message from The Pharmaceutical Care Management Association: During Diabetes Awareness Month, America’s pharmacy benefit managers, PBMs, continue their specialized work of helping diabetes patients get and take their prescription drugs affordably, conveniently and safely. Despite consistent manufacturer price increases on insulin products, PBM pharmacy experts help patients access and take medications as prescribed.
With a PBM on her side, Kaeana’s daughter, who lives with diabetes and a rare liver condition, can obtain all of her medications for $40 – not the $6,000 these prescription drugs would otherwise cost her.
“Without help, we would be paying $6,000 a month for medication, but because we have a PBM, I’m only paying $40 out of pocket,” Kaeana states. “It’s very important to have access to affordable medication, because if we didn’t, my child wouldn’t be alive.”
Hear Kaeana’s Story and learn more about how PBMs are working on behalf of all Americans living with diabetes. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
