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

By Ameet Sarpatwari, Beatrice Brown, Aviva Wang, 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 cost-effectiveness studies of oncology drugs approved between 2015 and 2020, to payer-specific negotiated prices for prescription drugs at top-performing US hospitals, to an assessment of access to COVID-19 vaccines in countries where they were tested.

A full posting of abstracts/summaries of these articles may be found on our website.

  1. Darrow JJ. Simplify Drug Labelling to Show Benefits Clearly. Nature. 2021 Nov;599(7884):181. PMID: 34754092.
  2. Feldman WB, Rome BN, Brown BL, Kesselheim AS. Payer-Specific Negotiated Prices for Prescription Drugs at Top-Performing US Hospitals. JAMA Intern Med. 2021 Nov 8:e216445. Epub ahead of print. PMID: 34747978.
  3. Haslam A, Lythgoe MP, Greenstreet Akman E, Prasad V. Characteristics of Cost-Effectiveness Studies for Oncology Drugs Approved in the United States From 2015-2020. JAMA Netw Open. 2021 Nov 1;4(11):e2135123. PMID: 34792592.
  4. Haslam A, Kim MS, Prasad V. Overall Survival for Oncology Drugs Approved for Genomic Indications. Eur J Cancer. 2021 Nov 21:S0959-8049(21)01186-2. Epub ahead of print. PMID: 34819251.
  5. Hwang TJ, Qin X, Keating NL, Huskamp HA, Dusetzina SB. Assessment of Out-of-Pocket Costs With Rebate Pass-through for Brand-name Cancer Drugs Under Medicare Part D. JAMA Oncol. 2021 Nov 11:e215433. Epub ahead of print. PMID: 34762097.
  6. Ramachandran R, Morten CJ, Ross JS. Strengthening the FDA’s Enforcement of Reporting Requirements. JAMA. 2021 Nov 12. Epub ahead of print. PMID: 34766971.
  7. Ramachandran R, Ross JS, Miller JE. Access to COVID-19 Vaccines in High-, Middle-, and Low-Income Countries Hosting Clinical Trials. JAMA Netw Open. 2021 Nov 1;4(11):e2134233. PMID: 34792596.
  8. Rome BN, Sarpatwari A. Promoting Biosimilar Competition by Revising Medicare Reimbursement Rules. JAMA Netw Open. 2021 Nov 1;4(11):e2134463. PMID: 34779852.
  9. Rome BN, Feldman WB, Fischer MA, Desai RJ, Avorn J. Influenza Vaccine Uptake in the Year After Concurrent vs Separate Influenza and Zoster Immunization. JAMA Netw Open. 2021 Nov 1;4(11):e2135362. PMID: 34797367.
  10. Sacks CA, North CM, Wolf M, Dougan M, Campbell KR, Moggridge J, Fralick M. The Landscape of COVID-19 Research in the United States: A Cross-Sectional Study of Randomized Trials Registered on ClinicalTrials.Gov. J Gen Intern Med. 2021 Nov 9:1–8. Epub ahead of print. PMID: 34755268.
  11. Sarpatwari A, Pandya A, Hyle EP, Persad G. COVID-19 Vaccine Boosters for All Adults: An Optimal U.S. Approach? Ann Intern Med. 2021 Nov 9. Epub ahead of print. PMID: 34748375.
  12. Wallach JD, Zhang AD, Skydel JJ, Bartlett VL, Dhruva SS, Shah ND, Ross JS. Feasibility of Using Real-World Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval. JAMA Netw Open. 2021 Nov 1;4(11):e2133667. PMID: 34751763.

Ameet Sarpatwari

Ameet Sarpatwari is an Instructor in Medicine at Harvard Medical School, an Associate Epidemiologist at Brigham and Women’s Hospital, and Assistant Director of the Program On Regulation, Therapeutics, And Law (PORTAL) within the Division of Pharmacoepidemiology and Pharmacoeconomics. His research draws upon his interdisciplinary training as an epidemiologist and lawyer and focuses on the effects of laws and regulations on therapeutic development, approval, use, and related public health outcomes.

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