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Recent Developments in U.S. Healthcare Policy

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Our recent webcast featuring Chris Jacobs, a policy writer and analyst based in Washington, D.C., shared insights into the latest developments across U.S. healthcare agencies and the evolving landscape of policy decisions. Jacobs highlighted significant changes at the Department of Health and Human Services (HHS), ongoing debates within the life sciences sector, shifts in drug development strategies, and the role of Congress in shaping healthcare policy.

HHS has undergone notable workforce reductions, with 10,000 to 20,000 employees affected, which has impacted internal operations and created tensions within the department. Political disputes among various factions, including the so-called MAGA coalition and allies of Secretary Kennedy, have further complicated policy implementation. Disagreements have arisen over the administration’s approach to the agriculture and pharmaceutical industries, reflecting a fragmented coalition with differing priorities.

Drug development policies remain a key focus of the administration. The National Institutes of Health (NIH) budget has been under scrutiny, with ongoing litigation over indirect cost recovery and concerns about grant cancellations tied to diversity initiatives. Jacobs noted a recent executive memorandum hinting at new restrictions on pharmaceutical advertising. FDA Commissioner Marty McCary suggested these rules could effectively limit direct-to-consumer advertising, sparking potential legal challenges from the pharmaceutical industry.

FDA leadership has also seen upheaval, with high-profile resignations and reinstatements, including those of Vinay Prasad and Peter Marks. These personnel changes reflect broader uncertainty about drug approvals and vaccine policy, with disputes over how regulatory decisions align with political priorities.

Vaccine policy continues to be a contentious issue with the recent meeting of the Advisory Committee on Immunization Practices (ACIP), which disappointed both vaccine advocates and skeptics. The administration has also signaled a focus on autism research, including plans to study potential links between autism and environmental or pharmaceutical factors. Secretary Kennedy has prioritized this issue, though critics question the scientific foundation of some proposed initiatives.

Congress remains deeply involved in shaping healthcare policy, particularly through appropriations and oversight. Recent legislation adjusted drug price negotiation policies under the Inflation Reduction Act, exempting certain orphan drugs from negotiations to encourage innovation. Tensions over NIH funding continue, with both the House and Senate proposing relatively flat budgets. Additionally, the looming possibility of a government shutdown could disrupt healthcare funding and stall new initiatives.

Jacobs concluded by acknowledging significant uncertainty in U.S. healthcare policy. While NIH funding appears stable, changes in grant priorities and executive influence over research institutions signal potential shifts. Meanwhile, debates over drug pricing, vaccine policy, and broader political dynamics ensure that healthcare will remain a critical and contested policy area in the months ahead.

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Speaker Biographies

Hilary Malone PhD, has over 25 years of experience in global drug development, regulatory &government affairs, manufacturing and commercialization within the biopharma industry. Hilary hassignificant board level and executive committee experience including large scale organizationalrestructuring/transformation/integration, major M&A, biotech start-up, capital raising, investorrelations and pre-IPO.​

Hilary is currently CEO of Stylus Medicine, a private genetic medicine biotech company. Previously sheserved as CEO of a Series-A neuroscience company. Prior to these roles, Hilary served as COO & EVP atValo Health Inc., Chief Regulatory Officer & SVP at Sanofi Inc., and Chief Regulatory Officer & SVP atPfizer and Wyeth. Previous experience also includes senior regulatory and drug development roles atReata Pharmaceuticals Inc., AstraZeneca plc and GlaxoSmithKline plc.​

Hilary also serves on the Board of Directors of Hansa Biopharma and Adthera Bio. Hilary holds a PhD inMolecular Neuropharmacology and a BSc in Physiology.

Dr. Thomas Lönngren is Director at his own company PharmaExec Consulting AB. He is the Chairman of the Board of directors at Egetis Therapeutics AB, Sweden. Dr Lönngren also serves as board member at Compass Pathways PLC, London UK and NDA Group, Sweden. He acts as advisor to the following companies and organizations: NDA group, Sweden, Sweden, Artis Venture, San Francisco, US, Fujimoto Japan, Skin2Neuron Pty Ltd, Sydney, Australia, US, Special advisor to the Centre for Innovation in Regulatory Science (CIRS), London UK. From 2001 until2011, Mr.Lönngren served as the Executive Director of the European Medical Agency. He was previously Deputy General Director of the Swedish Medical Product Agency until 2000. He has a degree in pharmacy and MSc in Social and Regulatory Pharmacy from Uppsala University. He is also an Honorary Member of the Royal Pharmaceutical Society of Great Britain, Honorary Fellow of the Royal College of Physicians in Great Britain, Honorary Doctorate from the University of Uppsala, Honorary Doctorate from University of Bath, UK.

Speaker Biographies

Marie-Anne Aymerich

Marie-Anne has built a portfolio of senior advisory and non-executive roles, following a successful international career in the FMCG and Luxury sectors. She is a non-executive director of Haleon, a FTSE100 company listed in 2022 after the demerger from GSK. She is also chairwoman of Haleon Environment and Societal Sustainability committee. She is the executive director of the Pierre Fabre Group where she also sits on the Strategic Committee, and she is a Board Member of The Academy of St. Martin-in-the-Fields, one of the world’s most prestigious chamber orchestras. She is also an angel investor and focuses her time and investments on start-ups with the strongest purpose and impact.

Marie-Anne is also a regular lecturer at HEC Paris on purposeful leadership, and she has created a serious game called “Planet Purpose” to upskill people on sustainability and purpose. Throughout her 35year executive career she delivered a strong track-record of business performance and growth in brands and portfolio in both developed and emerging economies.

As a senior leader with Unilever, she led a number of different personal care categories across France, Spain and the USA – including managing the Dove brand worldwide and culminating in leading Unilever’s global Oral Care division. She also worked for LVMH as Brand General Manager of Dior Perfumes and Cosmetics worldwide. Marie-Anne was also Vice-President of Imagine for Margo – Children with Cancer for ten years, a charity she helped found in 2011 with the goal of eradicating children’s cancer. The charity is the #1 charity focused on child cancer in France and has fundraised more than €14m since its creation. Marie-Anne is a graduate from HEC Paris. She is married and has two children aged 29 and 26.

Patrick Jephson

Patrick Jephson is a consultant, journalist, broadcaster and New York Times bestselling author, based in Washington D.C. He is a published authority on corporate and personal branding and crisis communications, addressing conferences worldwide as well as events at the U.S. State Department, the American University and the Annenberg School for Communication and Journalism.

With more than twenty-five years’ experience in the government, luxury and family office sectors, Patrick’s portfolio has included globally admired brands as well as national agencies and NGOs. He has also worked on reputation and legacy briefs with European, Middle Eastern and Asian families, including royalty. He now writes, presents, and advises on factual and drama TV programs, appearing on every major American and many international networks. He was recently an expert consultant to the award-winning Netflix series The Crown and provided live commentary on the Coronation of King Charles.

Patrick owes much of his practical communications and protocol experience to Princess Diana, who chose him to be her equerry and only private secretary/chief of staff. He served the Princess for eight years, responsible for all aspects of her public life, global humanitarian initiatives, and private organization. Having worked for an internationally high-profile woman (and as the father of two professionally successful daughters) he feels a special affinity for cross-cultural, gender and perception issues.

Patrick was born and raised in Ireland and holds a master’s degree in political science from Cambridge University. As an officer in the British Royal Navy, he served all over the world before being selected for royal duty. He is a citizen of the U.K., U.S.A., Ireland, and Canada.