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

By Ameet Sarpatwari, Alexander Egilman, Beatrice Brown, 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 January. The selections feature topics ranging from a discussion of why state laws restricting mifepristone access may be subject to federal preemption, to an analysis of patents impacting the availability of biosimilars, to an evaluation of the hypothetical out-of-pocket costs of guideline-recommended medications for the treatment of older adults with multiple chronic diseases. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Bloomfield D, Walsh BS, Kesselheim AS. Extending Drug Monopolies by Patenting Safe Drug Use. JAMA Intern Med. 2022 Jan 31. Epub ahead of print.
  2. Darrow JJ. Two Views of Cancer Medicines: Imagery Versus Evidence. Health Mark Q. 2022 Jan 7:1-12. Epub ahead of print.
  3. Frank RG, Shahzad M, Kesselheim AS, Feldman W. Biosimilar Competition: Early Learning. Health Econ. 2022 Jan 12. Epub ahead of print.
  4. Gunter SJ, Kesselheim AS, Rome BN. Medicaid Spending on Drugs Marketed Without US Food and Drug Administration Approval in 2020. JAMA Intern Med. 2022 Jan 18. Epub ahead of print.
  5. Kadakia KT, Beckman AL, Ross JS, Krumholz HM. Renewing the Call for Reforms to Medical Device Safety-The Case of Penumbra. JAMA Intern Med. 2022 Jan 1;182(1):59-65.
  6. Khorrami P, Sinha MS, Bhanja A, Allen HL, Kesselheim AS, Sommers BD. Differences in Diabetic Prescription Drug Utilization and Costs Among Patients With Diabetes Enrolled in Colorado Marketplace and Medicaid Plans, 2014-2015. JAMA Netw Open. 2022 Jan 4;5(1):e2140371.
  7. Mitra-Majumdar M, Kesselheim AS. Reporting Bias in Clinical Trials: Progress Toward Transparency and Next Steps. PLoS Med. 2022 Jan 19;19(1):e1003894.
  8. Rand LZ, Kesselheim AS. Performance-Linked Reimbursement and the Uncertainty of Novel Drugs. Circ Cardiovasc Qual Outcomes. 2022 Jan;15(1):e008642. Epub ahead of print.
  9. Sarpatwari A, Brown BL, McGraw SA, Dejene SZ, Abdurrob A, Santiago Ortiz AJ, Kesselheim AS. Patient and Caregiver Experiences With and Perceptions of Risk Evaluation and Mitigation Strategy Programs With Elements to Assure Safe Use. JAMA Netw Open. 2022 Jan 4;5(1):e2144386.
  10. Schummers L, Darling EK, Dunn S, McGrail K, Gayowsky A, Law MR, Laba TL, Kaczorowski J, Norman WV. Abortion Safety and Use with Normally Prescribed Mifepristone in Canada. N Engl J Med. 2022 Jan 6;386(1):57-67. Epub ahead of print.
  11. Van de Wiele VL, Beall RF, Kesselheim AS, Sarpatwari A. The Characteristics of Patents Impacting Availability of Biosimilars. Nat Biotechnol. 2022 Jan;40(1):22-25.
  12. Walsh BS, Kesselheim AS, Sarpatwari A, Rome BN. Indication-Specific Generic Uptake of Imatinib Demonstrates the Impact of Skinny Labeling. J Clin Oncol. 2022 Jan 11:JCO2102139. Epub ahead of print.
  13. Zettler PJ, Sarpatwari A. State Restrictions on Mifepristone Access – The Case for Federal Preemption. N Engl J Med. 2022 Jan 12. Epub ahead of print.
  14. Zhou T, Liu P, Dhruva SS, Shah ND, Ramachandran R, Berg KM, Ross JS. Assessment of Hypothetical Out-of-Pocket Costs of Guideline-Recommended Medications for the Treatment of Older Adults With Multiple Chronic Conditions, 2009 and 2019. JAMA Intern Med. 2022 Jan 4:e217457. Epub ahead of print.

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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