Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.
| | | | |  | | By Lauren Gardner | With help from Megan R. Wilson
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Rep. Brad Wenstrup, who leads the House GOP's investigation of the origins of Covid-19, says he won't seek reelection next year. | Manuel Balce Ceneta/AP | | | | | BALANCING ACT ON BIOSECURITY — Legislation targeting Chinese-owned biotech firms is putting the pharma industry in a bind, Megan reports, as Western companies wrestle with the security and privacy implications of their reliance on China’s supply-chain dominance. The measure — known as the BIOSECURE Act — would effectively prohibit Chinese biotech companies from doing business in the U.S. It’s been gaining momentum in Congress as cracking down on China has become a bipartisan issue. Companies appearing to favor the bill risk angering Beijing, which has a penchant for corporate retaliation, while companies eyeing carve-outs could look lax on national security. Speaking in favor of the legislation “can put people in danger,” said a lobbyist specializing in trade and international issues granted anonymity to discuss private concerns. While more than a dozen U.S. and European pharma and biotech companies — including AstraZeneca, Illumina, Vertex Pharmaceuticals and EMD Serono — have disclosed lobbying on the legislation, almost none is willing to discuss it. The companies mentioned in the bill, which is scheduled for a House markup on May 15, include some used by U.S. drugmakers as they research, develop and make medicines, and manufacture platforms to sequence and analyze genomic data used to create personalized treatments. Intelligence officials warn that collecting this data comes with privacy risks and gives China a competitive advantage at the expense of U.S. companies. Lawmakers allege China’s collection of genomic data could be used for nefarious purposes, such as creating bioweapons that target certain populations. A Senate panel advanced its version of the measure in March in an 11-1 vote following briefings with intelligence officials. Industry group PhRMA quietly worked out a compromise with lawmakers that would grandfather existing contracts, a change the House is expected to approve. IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. May the Fourth be with you this weekend! Send news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).
| | | | THE GOLD STANDARD OF HEALTHCARE POLICY REPORTING & INTELLIGENCE: POLITICO has more than 500 journalists delivering unrivaled reporting and illuminating the policy and regulatory landscape for those who need to know what’s next. Throughout the election and the legislative and regulatory pushes that will follow, POLITICO Pro is indispensable to those who need to make informed decisions fast. The Pro platform dives deeper into critical and quickly evolving sectors and industries, like healthcare, equipping policymakers and those who shape legislation and regulation with essential news and intelligence from the world’s best politics and policy journalists.
Our newsroom is deeper, more experienced and better sourced than any other. Our healthcare reporting team—including Alice Miranda Ollstein, Megan Messerly and Robert King—is embedded with the market-moving legislative committees and agencies in Washington and across states, delivering unparalleled coverage of health policy and the healthcare industry. We bring subscribers inside the conversations that determine policy outcomes and the future of industries, providing insight that cannot be found anywhere else. Get the premier news and policy intelligence service, SUBSCRIBE TO POLITICO PRO TODAY. | | | | | | | | DRUG SHORTAGE DISCUSSION — The Democratic and Republican leaders of the Senate Finance Committee released a discussion draft this morning of legislation leveraging Medicare and Medicaid programs to prevent and mitigate generic drug shortages. The proposal would establish a Medicare incentive payment program for hospitals and providers to use to entice supply-chain players like group purchasing organizations and wholesalers to meet “minimum core standards” for contracting and purchasing generic medicines. The standards include minimum three-year contracts with manufacturers, purchase volume requirements and contingency contracts with alternate suppliers, according to a committee summary of the bill. “Advanced” standards tied to factors like domestic manufacturing could spur additional payments. The draft suggests allowing reductions or waivers to the Medicaid inflation rebate for sole-source generics in case of shortages, as current law provides for Medicare. “Middlemen like GPOs should not be able to do business with Medicare if their contracting practices are actively worsening the drug shortage challenge in America,” Committee Chair Ron Wyden (D-Ore.) said in a statement. Background: The availability of generic drugs like sterile injectables and common chemotherapies has been tight for years, a phenomenon attributed to supply-chain issues exacerbated by the Covid-19 pandemic and market dynamics that make manufacturing the cheaper products a money-loser for companies. HHS released a billion-dollar proposal in April to institute payment incentives — and penalties — for hospitals to meet good purchasing practices to help avert drug shortages.
| | | GLP-1 EARNINGS FRENZY — Novo Nordisk and Eli Lilly — the two pharmaceutical giants behind blockbuster diabetes and obesity drugs known as GLP-1s — posted strong sales performances in the first quarter of the year, according to earnings readouts this week. But while those products drove growth, both companies still face issues meeting demand. Novo executives declined to speculate on the extent to which the company expects to scale supply of anti-obesity drug Wegovy into 2025. The company has quintupled the number of new prescriptions as it gradually lifts limits on starter doses. But Chief Financial Officer Karsten Munk Knudsen acknowledged during a Thursday earnings call that the drug’s net price is down in the U.S. thanks to growing competition from rival Lilly drugs. Lilly executives cautioned on their earnings call on Tuesday that the company expects supply and demand to “remain quite tight” into 2025, despite having seven facilities either under construction or ramping up to produce GLP-1 medications. “I expect that the demand will outpace supply through this year, potentially next year,” said CFO Anat Ashkenazi. “We'll continue to invest and ramp as we go into next year, but it could be quite some time.” MODERNA BULLISH ON RSV SHOT — Moderna executives signaled confidence Thursday that the drugmaker’s RSV vaccine can compete with shots already on the market if the FDA approves it this month. CEO Stéphane Bancel touted the vaccine candidate’s safety and efficacy data as “stronger” than competitors’ though another company official noted Moderna expects CDC vaccine advisers to make a parity recommendation for the shot alongside rivals. Bancel suggested the shot’s presentation — a pre-filled syringe — could be a game-changing differentiator for busy health care providers. GSK and Pfizer make RSV vaccines that have been available for a year, making Moderna a late-stage entrant to the market. But those products require multiple steps to prepare the vaccines for administration, Bancel said. “We believe our [pre-filled syringe] presentation for RSV vaccine has the potential to ease the personal burden on pharmacies during the fall respiratory season,” he said during the company’s first-quarter earnings call.
| | ILLEGAL E-CIG CRACKDOWN — The FDA and DOJ announced earlier this week that the U.S. Marshals Service confiscated more than 45,000 unauthorized e-cigarettes from a warehouse in Alhambra, Calif. The move is the first time the two agencies have worked with the U.S. Marshals Service to seize tobacco products. It comes shortly after lawmakers during a budget hearing last month pressed FDA Commissioner Robert Califf on enforcement efforts of illegal e-cigarettes. “This type of action must be the first of many aimed at vigorously enforcing the Tobacco Control Act and protecting from illegal and dangerous tobacco products,” said Erika Sward, assistant vice president of nationwide advocacy for the American Lung Association.
| | | | POLITICO IS BACK AT THE 2024 MILKEN GLOBAL CONFERENCE: POLITICO will again be your eyes and ears at the 27th Annual Milken Institute Global Conference in Los Angeles from May 5-8 with exclusive, daily, reporting in our Global Playbook newsletter. Suzanne Lynch will be on the ground covering the biggest moments, behind-the-scenes buzz and on-stage insights from global leaders in health, finance, tech, philanthropy and beyond. Get a front-row seat to where the most interesting minds and top global leaders confront the world’s most pressing and complex challenges — subscribe today. | | | | | | | | Pamela Gavin has succeeded Peter Saltonsall as CEO of the National Organization for Rare Disorders. She was most recently the group’s executive vice president.
|  | what we're reading | | Novartis is making a $1 billion bet on radiopharmaceutical startup Mariana Oncology, EndPoints News’ Kyle LaHucik reports.
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