Month-to-month Spherical-Up of What to Learn on Pharma Regulation and Coverage

Every month, members of the Program On Regulation, Therapeutics, And Regulation (PORTAL) assessment the peer-reviewed medical literature to determine fascinating empirical research, coverage analyses, and editorials on well being legislation and coverage points. Under are the citations for papers recognized from the month of February. The alternatives function subjects starting from an evaluation of the approval and advertising of biosimilars with a thin label and their related Medicare financial savings, to a dialogue of the Philips Respironics recall and the necessity for reforms to U.S. medical gadget regulation, to a assessment of worth negotiation processes in peer nations and potential classes for Medicare worth regulation. A full posting of abstracts/summaries of those articles could also be discovered on our web site.

1. Demkowicz BJ, Tu SS, Kesselheim AS, Service MA, Feldman WB. Patenting Methods on Inhaler Supply Units. Chest. 2023 Feb 25;S0012-3692(23)00301-X. Epub forward of print.
2. DiStefano MJ, Markell JM, Doherty CC, Alexander GC, Anderson GF. Affiliation Between Drug Traits and Producer Spending on Direct-to-Shopper Promoting. JAMA. 2023 Feb 7;329(5):386-392.
3. Dubin JM, Fantus RJ, Bennett NE, Brannigan RE, Thirumavalavan N, Halpern JA. Guideline-Discordant Care Amongst Direct-to-Shopper Testosterone Remedy Platforms. JAMA Intern Med. 2022 Dec 1;182(12):1321-1323.
4. Johnston JL, Ross JS, Ramachandran R. US Meals and Drug Administration Approval of Medication Not Assembly Pivotal Trial Main Finish Factors, 2018-2021. JAMA Intern Med. 2023 Feb 13:e226444. Epub forward of print.
5. Naci H, Forrest R, Zhai M, Stofesky AR, Kesselheim AS. Traits of Prior Authorization Insurance policies for New Medication in Medicare Half D. JAMA Well being Discussion board. 2023 Feb 3;4(2):e225610.
6. Pham C, Le Ok, Draves M, Seoane-Vazquez E. Evaluation of FDA-Accepted Medication Not Beneficial for Use or Reimbursement in Different International locations, 2017-2020. JAMA Intern Med. 2023 Feb 13:e226787. Epub forward of print.
7. Rome BN, Gunter SJ, Kesselheim AS. Market dynamics of approved generics in Medicaid from 2014 to 2020. Well being Serv Res. 2023 Feb 23. Epub forward of print.
8. Tu SS, Nagar S, Kesselheim AS. Current Patent Reform Payments and Their Implications for Prescription Medication. JAMA. 2023 Feb 14;329(6):459-460.
9. Tu SS, Sarpatwari A. A “Technique of Use” to Stop Generic and Biosimilar Market Entry. N Engl J Med. 2023 Feb 9;388(6):483-485.
10. Van de Wiele VL, Kesselheim AS, Beran D, Darrow JJ. Insulin merchandise and patents within the USA in 2004, 2014, and 2020: a cross-sectional examine. Lancet Diabetes Endocrinol. 2023 Feb;11(2):73-75.

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