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Presented by PBM Accountability Project: 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 Megan R. Wilson and Josh Sisco
| | |  House Speaker Kevin McCarthy and his fellow Republicans face a packed agenda this week. | Francis Chung/POLITICO | FIGHTS LOOM WITH FDA APPROPS — The House is slated to consider legislation later this week funding the FDA and the Department of Agriculture for fiscal 2024, with the Rules Committee meeting Wednesday to set the debate parameters before lawmakers leave for the August recess. That bill and another measure to fund veterans programs are on the floor schedule this week because they’re two of House Republicans’ easier spending bills to work through before federal funding dries up on Sept. 30. Still, the Ag-FDA legislation is expected to serve as a flashpoint for abortion and tobacco policy fights. Biden veto threat: The White House threatened Monday to veto the bill if it’s passed as is, citing Republicans’ reneging on spending levels agreed to last spring and their insistence on prohibiting mail delivery of abortion pills and handcuffing the FDA’s ability to ban menthol in cigarettes. One Republican member, Rep. Marc Molinaro (R-N.Y.), has said he opposes the measure because of its provision on mifepristone. Amendment rundown: Members have submitted 164 amendments — though some are revised versions of earlier proposals or have already been withdrawn — to be considered for floor debate. They include one from Democrats to strike from the bill language banning mailing mifepristone and dispensing the drug at retail pharmacies plus a handful from Rep. Marjorie Taylor Greene (R-Ga.) prohibiting funding for transgender care for minors. Related reading: Pro Budget reporters Caitlin Emma and Jennifer Scholtes set up the House GOP’s whipping frenzy on the spending bills this week. And our Alice Miranda Ollstein examines how Republicans and outside conservative groups use the broader appropriations process to make their mark on health policies targeting abortion, contraception and other matters. IT’S TUESDAY. WELCOME TO PRESCRIPTION PULSE. Have you already seen “Barbie”? “Oppenheimer”? Or, dare we say it, both? Send news, tips and movie reviews to Katherine Ellen Foley (kfoley@politico.com or @katherineefoley), Lauren Gardner (lgardner@politico.com or @Gardner_LM or @gardnerlm19) and David Lim (dlim@politico.com or @davidalim or @david.a.lim). TODAY ON OUR PULSE CHECK PODCAST, host Ben Leonard talks with Alice Miranda Ollstein, who explains how the culture wars are more prominently featuring into this year’s appropriations process as Republicans are riding on must-pass appropriations bills to advance an agenda on health issues — and preparing for spending fights over abortion, trans care and more.
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Senate Finance Committee Chair Ron Wyden (l.) and ranking member Mike Crapo (R-Idaho) want to rein in pharmacy benefit managers. | Francis Chung/POLITICO via AP Images | MOVING ON PBM AGENDA — The Senate Finance Committee is considering a sweeping proposal to rein in pharmacy benefit managers Wednesday, Megan reports. The measure combines a slew of bipartisan proposals into one bill, a result of months of work by committee members to execute the “roadmap” of PBM-centric policy laid out by Chair Ron Wyden (D-Ore.) and ranking member Mike Crapo (R-Idaho) in April. The leaders aim to crack down on business practices used by the industry, an intermediary between health plans and pharmaceutical companies. One measure would require PBMs to report more data to the government, while another would “delink” their compensation from the amount pharmaceutical companies offer in discounts for placing a medicine on the list of drugs health plans cover. The bill also bans spread pricing in Medicaid, a practice in which PBMs charge health plans more than they reimburse pharmacies for a drug. The industry has pushed back on accusations from members of both parties that PBMs drive up the cost of medicines — arguing that pharmaceutical companies are responsible for setting the price of drugs.
| | | | JOIN 7/26 FOR A TALK ON THE NEW ENERGY ECONOMY: Join POLITICO's lively discussion, "Powering a Clean Energy Economy," on July 26 to explore the effectiveness of consumer-targeted policies to boost sustainability and create clean energy jobs. How are the Inflation Reduction Act's provisions faring? Which strategies truly sway consumer behavior? Hear from featured speaker, Rep. Debbie Dingell (D-Mich.), among other experts. Don't miss this insightful event — register today and be part of the conversation driving America's clean energy future! REGISTER NOW. | | | | | | | | | AGENCIES PROBE TB OUTBREAK — The CDC, the FDA and state health departments are investigating a tuberculosis outbreak that officials suspect is tied to contaminated bone and tissue products shipped to hospitals and dental offices in at least seven states. Aziyo Biologics announced a recall earlier this month of its bone-repair products after two patients who received transplants became infected, one fatally. The CDC said the cases appear to be connected to a single product called ViBone, a bone-forming repair product made from human tissue that is typically used in orthopedic and spinal surgeries, and the infections were linked to products from a single donor lot. Aziyo issued a recall in 2021 for a similar product contaminated with TB. Eight patients died after surgeries using the products.
| | | | A message from PBM Accountability Project: PBM profits are tied to the cost of drugs. That means that PBMs make more money if drug prices are higher. Let’s end the PBM shell game once and for all. Learn more. | | | KHAN: NOT ALL PHARMA MERGERS ARE BAD — FTC Chair Lina Khan laid out a more nuanced stance on pharmaceutical mergers following criticism that a recent lawsuit to block Amgen’s takeover of Horizon Pharmaceuticals could hamper development of innovative new drugs, Josh reports. “Where you have newer drugs, or drugs that have not fully come to market and they need to be bought out in order to go down the commercialization chain, that provides a very different set of facts than instances in which we see acquisitions of existing blockbuster drugs,” said Khan at an event Monday at the New York Economic Club. Jay Markowitz, a senior partner with health care investment firm ARCH Venture Partners, expressed concern about recent FTC actions, such as the Amgen lawsuit and an unnamed portfolio company trying to ink a licensing deal with a larger player in which he said the FTC “intervened.” Khan said the FTC has also heard concerns from investors that a limited number of potential acquirers makes it harder to negotiate favorable acquisition terms. “And so even if at the end of the day, you’re going to have to have some of those acquisitions for that commercialization path, more competition and more jostling among the potential buyers” is better for innovation,” Khan said.
| | SEEKING E-CIG ANALYSIS — The FDA seeks a company to analyze the safety of 125 flavoring chemicals commonly used in vapes. The agency will provide the company with the list of chemicals, and the company will test for the toxicity of those chemicals on cells and living lung tissue over two years. So far, the agency has authorized only 23 e-cigarette products for sale out of millions that have asked for authorization. All authorized vapes are tobacco flavored; the agency has denied bids for companies trying to sell nontobacco-flavored vapes, including menthol vapes, stating that the risk of children getting hooked is too high. But despite rejecting marketing orders for nontobacco-flavored vapes, the FDA has not been able to keep illegal flavored vapes off store shelves, and they remain popular. JOB OPENINGS — The FDA said Monday it was searching for a division director for the Center for Drug Evaluation and Research, plus an IT specialist within the Center for Biologics Evaluation and Research.
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RSV PROGRAM CLOSED — A late-stage clinical trial showed that Bavarian Nordic’s respiratory syncytial virus vaccine candidate for adults 60 and older had less than 43 percent efficacy against severe disease, leading the company to stop its RSV program.
| | Rosemary Roberts, director of the Counter-Terrorism and Emergency Coordination Staff in the Office of the Center Director at the FDA, is retiring after nearly 20 years in the position. Kelly Ngan, the CTECS associate director, will serve as acting director. President Joe Biden named Shuwanza Goff as assistant to the president and director of the White House’s Office of Legislative Affairs.
| | | | JOIN 7/27 FOR A TALK ON WOMEN LEADERS IN THE NEW WORKPLACE: In the wake of the pandemic, U.S. lawmakers saw a unique opportunity to address the current childcare system, which has become increasingly unaffordable for millions of Americans, but the initial proposals went nowhere. With the launch of the Congressional Bipartisan Affordable Childcare Caucus in May, there may be a path to make childcare more affordable. Join Women Rule on July 27 to dive into this timely topic and more with featured speakers Rep. Nancy Mace (R-S.C.), Rep. Ro Khanna (D-Calif.) and Reshma Saujani, Founder & CEO of Moms First and Founder of Girls Who Code. REGISTER HERE. | | | | | | | | | For The New York Times, Robert Kolker reports on one family’s intergenerational struggle to live with a heritable form of dementia.
| | Senators Bill Cassidy (R-La.), Marco Rubio (R-Fla.), Ted Budd (R-N.C.) and Bill Hagerty (R-Tenn.) sent a letter Monday to FDA Commissioner Robert Califf expressing concern that forthcoming rules that would ban menthol cigarettes could lead to an expansion of illicit tobacco trade from Mexican transnational criminal organizations. The FDA published final guidance Monday on how best to limit potential carcinogenic risk from impurities in pharmaceuticals.
| | | | A message from PBM Accountability Project: Every time you go to the pharmacy counter, health insurance middlemen called pharmacy benefit managers – or PBMs – increase their already high profits. Last year alone, the top 3 PBMs recorded more than $27 billion in profits.
It’s time to end the PBM shell game. There is growing, bipartisan agreement in Congress to break the link between the price of medicine and PBM revenues to help Americans afford and access their medications.
Voters agree. More than 80% of voters want to stop PBMs from directly profiting off drug prices.
We need actionable reforms to hold PBMs accountable and to address the games they play that drive up out-of-pocket costs at the pharmacy counter. Decisive action is needed by Congress today. Learn more. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
