By Ameet Sarpatwari, Alexander Egilman, and Aaron S. Kesselheim
Every month, members of the Program On Regulation, Therapeutics, And Legislation (PORTAL) evaluation the peer-reviewed medical literature to determine fascinating empirical research, coverage analyses, and editorials on well being legislation and coverage points.
Beneath are the citations for papers recognized from the month of November. The picks characteristic subjects starting from an evaluation of the approval and advertising of biosimilars with skinny labels and their related financial savings to Medicare, a dialogue of the Philips Respironics recall and the necessity for reforms to medical gadget regulation, to a evaluation of worth negotiation processes in peer international locations and potential classes for Medicare worth regulation. A full posting of abstracts/summaries of those articles could also be discovered on our web site.
- Beall RF, Glazer T, Ahmad H, et al. Patent “Evergreening” of Drugs-Gadget Mixture Merchandise: A International Perspective. Healthcare Coverage. 2022 Nov;18(2):14-26.
- Egilman AC, Van de Wiele VL, Rome BN, et al. Frequency of Approval and Advertising and marketing of Biosimilars With a Skinny Label and Related Medicare Financial savings. JAMA Inner Drugs. 2022 Nov 28. Epub forward of print.
- Kadakia KT, Ross JS, Rathi VK. The Philips Respironics Recall of Ventilators and Optimistic Airway Stress Machines-Breakdowns in Medical Gadget Surveillance. JAMA Inner Drugs. 2022 Nov 14. Epub forward of print.
- Krastein J, Sahin L, Yao L. A Evaluation of Being pregnant and Lactation Postmarketing Research Required by the FDA. Pharmacoepidemiology and Drug Security. 2022 Nov 19. Epub forward of print.
- Nagar S, Rand LZ, Kesselheim AS. What Ought to US Policymakers Study From Worldwide Drug Pricing Transparency Methods? AMA Journal of Ethics. 2022 Nov 1;24(11):E1083-1090.
- Pathak Okay, Narang C, Hwang TJ, Espinoza JC, Bourgeois FT. Excessive-risk Therapeutic Units Accepted by the US Meals and Drug Administration for Use in Youngsters and Adolescents From 2016 to 2021. JAMA Pediatrics. 2022 Nov 7:e224131. Epub forward of print.
- Rand LZ, Kesselheim AS. Getting the Value Proper: Classes for Medicare Value Negotiation from Peer International locations. PharmacoEconomics. 2022 Dec;40(12):1131-1142. Epub forward of print.
- Zhai MZ, Avorn J, Liu J, Kesselheim AS. Variations in Use of Diabetes Medication With Cardiovascular Advantages Amongst Medicaid Sufferers. JAMA Community Open. 2022 Nov 1;5(11):e2240117.
The put up Month-to-month Spherical-Up of What to Learn on Pharma Legislation and Coverage appeared first on Invoice of Well being.
