Program on Regulation, Therapeutics, and Law (PORTAL)

🔊 Tune into the latest episode of the Health and Veritas podcast hosted by Howard Forman and Harlan Krumholz, featuring PORTAL Director Aaron S. Kesselheim, M.D., J.D., M.P.H.! https://lnkd.in/eWNwSRc5

Check out the latest research from PORTAL in the December edition the PORTAL Post monthly newsletter on topics including: 🔹 The legal protections given to biologics vs. small molecule drugs 🔹 Reforms to clear drug patent thickets 🔹 The impact of political uncertainty on vaccine confidence 🔹 Clinician antibiotic prescribing practices 🔹 And more! ⭐ You can also learn more and register for our upcoming seminar on February 7, 2025 on private equity in health care organized in collaboration with the HMS Center for Bioethics and the Petrie-Flom Center: https://lnkd.in/eFryUYaN #rx #pharmacy #patent #amr #vaccines #FDA #drugs #healthcare #healthpolicy

High prescription drug costs in the US hinder patient access to medication, but there are strategies that clinical teams can use to help patients manage these costs. https://ja.ma/3Otccb5

New in the Journal of General Internal Medicine: Dongzhe Hong and colleagues discuss the results of a survey of 130 physicians' #antibiotic prescribing practices. They find that clinicians prioritized clinical outcomes (e.g., cure rate, severity of infection, side effects) when deciding which antibiotic to prescribe over other societal or economic factors like the risk of antibiotic resistance or patient out-of-pocket costs. Read here: https://lnkd.in/g88u5myF Aaron S. Kesselheim, M.D., J.D., M.P.H. Robert Morlock Joshua Metlay John H. Powers III William Feldman, MD, DPhil, MPH Society of General Internal Medicine (SGIM) #amr #pharmacy #rx #AMRawarenessweek #healthcare

Biologics receive greater legal protections in the US than small-molecule drugs. In a new JAMA study, we analyzed whether these protections are justified. Biologics represent 2% of prescriptions in the US but tend to be more expensive and account for approximately half of total drug spending. They receive longer periods of market exclusivity and protection from price negotiation than small-molecule drugs. The justification has been that biologic developers need more protections to recoup their development costs. We found no evidence supporting this differential treatment. Biologics had higher clinical trial success rates than small-molecule drugs at each phase of development and similar development times and costs. Biologics were also protected by many more patents and generated substantially higher revenues. These results call into question the need for policies that protect biologics from competition or price negotiation for longer periods than small-molecule drugs. US law appears to overly reward the development of biologics relative to small-molecule drugs. Matthew Vogel, William Feldman, MD, DPhil, MPH, Reed Beall, Aaron S. Kesselheim, M.D., J.D., M.P.H., S. Sean Tu https://lnkd.in/eRuT_6bF

New paper out led by Olivier Wouters on the empirical assumptions underlying differential protection for biologics & small-molecule drugs. Upshot: We found no good evidence supporting differential treatment by the FDA (or under the IRA). With Matthew Vogel, Reed Beall, Aaron S. Kesselheim, M.D., J.D., M.P.H., S. Sean Tu, Program on Regulation, Therapeutics, and Law (PORTAL) https://lnkd.in/g43eNYMX

Among the government-funded academic inventors on US drug patents, the majority were senior researchers at prestigious institutions. https://ja.ma/4fQKOAd

🌟 Deadline Approaching! 🌟 There are less than two weeks left to apply for two paid research fellowships with the PORTAL team. Apply by December 1, 2024. Learn more about the positions here: https://lnkd.in/eS2xGQCz

🎙️ Check out this new NEJM Group audio interview recapping where we are with Medicare price negotiation and how to think about the results from the first 10 drugs. https://lnkd.in/eqJ_7Mhc

Check out the latest from PORTAL in the Journal of Health Politics, Policy, and Law. Daniel Carpenter and colleagues assess the impact of electoral politics and political uncertainty on vaccine hesitancy, using the FDA approval and roll-out of the COVID-19 vaccines in the months before the 2020 US election as a case study. https://lnkd.in/eUYB8T2x Matthew Dardet, Anushka B., Leah Rand, William Feldman, MD, DPhil, MPH, Aaron S. Kesselheim, M.D., J.D., M.P.H. #healthpolicy #publichealth #vaccines #COVID19 #FDA