Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Alexander Egilman, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of November. The selections feature topics ranging from an analysis of the approval and marketing of biosimilars with skinny labels and their associated savings to Medicare, a discussion of the Philips Respironics recall and the need for reforms to medical device regulation, to a review of price negotiation processes in peer countries and potential lessons for Medicare price regulation. A full posting of abstracts/summaries of these articles may be found on our website.

1. Beall RF, Glazer T, Ahmad H, et al. Patent “Evergreening” of Medicine-Device Combination Products: A Global Perspective. Healthcare Policy. 2022 Nov;18(2):14-26.
2. Egilman AC, Van de Wiele VL, Rome BN, et al. Frequency of Approval and Marketing of Biosimilars With a Skinny Label and Associated Medicare Savings. JAMA Internal Medicine. 2022 Nov 28. Epub ahead of print.
3. Kadakia KT, Ross JS, Rathi VK. The Philips Respironics Recall of Ventilators and Positive Airway Pressure Machines-Breakdowns in Medical Device Surveillance. JAMA Internal Medicine. 2022 Nov 14. Epub ahead of print.
4. Krastein J, Sahin L, Yao L. A Review of Pregnancy and Lactation Postmarketing Studies Required by the FDA. Pharmacoepidemiology and Drug Safety. 2022 Nov 19. Epub ahead of print.
5. Nagar S, Rand LZ, Kesselheim AS. What Should US Policymakers Learn From International Drug Pricing Transparency Strategies? AMA Journal of Ethics. 2022 Nov 1;24(11):E1083-1090.
6. Pathak K, Narang C, Hwang TJ, Espinoza JC, Bourgeois FT. High-risk Therapeutic Devices Approved by the US Food and Drug Administration for Use in Children and Adolescents From 2016 to 2021. JAMA Pediatrics. 2022 Nov 7:e224131. Epub ahead of print.
7. Rand LZ, Kesselheim AS. Getting the Price Right: Lessons for Medicare Price Negotiation from Peer Countries. PharmacoEconomics. 2022 Dec;40(12):1131-1142. Epub ahead of print.
8. Zhai MZ, Avorn J, Liu J, Kesselheim AS. Variations in Use of Diabetes Drugs With Cardiovascular Benefits Among Medicaid Patients. JAMA Network Open. 2022 Nov 1;5(11):e2240117.