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

By Ameet Sarpatwari, Frazer Tessema, 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 relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of June. The selections feature topics ranging from premarket development times for biologics versus small-molecule drugs, to the characteristics of trials and regulatory pathways leading to U.S. approval of innovative vs. non-innovative drugs, to generic and brand-name thyroid hormone drug use among commercially insured and Medicaid beneficiaries. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Beall RF, Hwang TJ, Kesselheim AS. Pre-market development times for biologic versus small-molecule drugs. Nat Biotechnol. 2019 Jun 18. [Epub ahead of print]
  2. Bikdeli B, Welsh JW, Akram Y, Punnanithinont N, Lee I, Desai NR, Kaul S, Stone GW, Ross JS, Krumholz HM. Non-Inferiority Designed Cardiovascular Trials in Highest-Impact Journals: Main Findings, Methodological Quality and Time Trends. Circulation. 2019 Jun 10. [Epub ahead of print]
  3. Gordon SH, Sommers BD, Wilson I, Galarraga O, Trivedi AN. The Impact of Medicaid Expansion on Continuous Enrollment: a Two-State Analysis. J Gen Intern Med. 2019 Jun 21. Epub ahead of print]
  4. Largent EA, Heffernan KG, Joffe S, Lynch HF. Paying Clinical Trial Participants: Legal Risks and Mitigation Strategies. J Clin Oncol. 2019 Jun 14. [Epub ahead of print]
  5. Ross JS, Rohde S, Sangaralingham L, Brito JP, Choi L, Dutcher SK, Graham DJ, Jenkins MR, Lipska KJ, Mendoza M, Qiang Y, Wang Z, Wu Y, Yao X, Shah ND. Generic and Brand-Name Thyroid Hormone Drug Use Among Commercially Insured and Medicare Beneficiaries, 2007 Through 2016. J Clin Endocrinol Metab. 2019 Jun 1;104(6):2305-2314.
  6. Rutkow L, McGinty MD, Wetter S, Vernick JS. Local Public Health Policymakers’ Views on State Preemption: Results of a National Survey, 2018.Am J Public Health. 2019 Jun 20:e1-e4. [Epub ahead of print]
  7. Vokinger KN, Kesselheim AS. Characteristics of trials and regulatory pathways leading to US approval of innovative vs. non-innovative oncology drugs. Health Policy. 2019 Jun 12. pii: S0168-8510(19)30153-8. [Epub ahead of print]
Ameet Sarpatwari

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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