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 relevant to current or potential future work in the Division.
Below are the abstracts/summaries for papers identified from the month of October. The selections feature topics ranging from newly enacted incentives for increasing diversity in clinical trials, to an analysis of how patients’ out of pocket costs changed after biosimilar versions of infliximab entered the US market, to an evaluation of how manufacturers have navigated postmarket requirements for drugs recently approved by the FDA. A full posting of abstracts/summaries of these articles may be found on our website.
- Brown BL, Mitra-Majumdar M, Darrow JJ, Moneer O, Pham C, Avorn J, Kesselheim AS. Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016. JAMA Intern Med. 2022 Oct 3:e224226. Epub ahead of print.
- Califf RM, Cavazzoni P, Woodcock J. Benefits of Streamlined Point-of-CareTrial Designs: Lessons Learned From the UK RECOVERY Study. JAMA Intern Med. 2022 Oct 24. Epub ahead of print.
- Dhodapkar MM, Shi X, Ramachandran R, Chen EM, Wallach JD, Ross JS. Characterization and corroboration of safety signals identified from the US Food and Drug Administration Adverse Event Reporting System, 2008-19: cross sectional study. 2022 Oct 5;379:e071752.
- Dhruva SS, Ramachandran R, Ross JS. Medicare’s National Coverage Determination for Aducanumab – A One-Off or a Pragmatic Path Forward? N Engl J Med. 2022 Oct 27;387(17):1539-1541. Epub 2022 Oct 22.
- Feng K, Kesselheim AS, Russo M, Rome BN. Patient Out-of-Pocket Costs Following the Availability of Biosimilar Versions of Infliximab. Clin Pharmacol Ther. 2022 Oct 13. Epub ahead of print.
- Hwang TJ, Brawley OW. New Federal Incentives for Diversity in Clinical Trials. N Engl J Med. 2022 Oct 13;387(15):1347-1349. Epub 2022 Oct 8.
- Hwang TJ, Kesselheim AS, Vokinger KN. Reforming the World Health Organization’s Essential Medicines List: Essential but Unaffordable. 2022 Oct 24. Epub ahead of print.
- Miljkovic MD, Tuia JE, Olivier T, Haslam A, Prasad V. Association Between US Drug Price and Measures of Efficacy for Oncology Drugs Approved by the US Food and Drug Administration From 2015 to 2020. JAMA Intern Med. 2022 Oct 31. Epub ahead of print.
- Rand LZ, Kesselheim AS. Limitations on the Capability of the FDA to Advise. Am J Bioeth. 2022 Oct;22(10):15-17.
- Rome BN, Egilman AC, Patel NG, Kesselheim AS. Using Multiple Authorized Generics to Maintain High Prices: The Example of Entacapone. Value Health. 2022 Oct 17:S1098-3015(22)02181-7. Epub ahead of print.
- Walsh BS, Kesselheim AS, Rome BN. Medicaid Spending on Antiretrovirals from 2007-2019. Clin Infect Dis. 2022 Oct 21:ciac833. Epub ahead of print.