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

By Ameet Sarpatwari 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 March. The selections feature topics ranging from out-of-pocket spending on orphan drugs, to the comparative effectiveness of generic vs. brand-name drugs, to the association the transmucosal immediate-release fentanyl REMS with TIRF-product prescribing. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Beall RF, Hwang TJ, Kesselheim AS. Major Events in the Life Course of New Drugs, 2000-2016. N Engl J Med. 2019 Mar 14;380(11):e12.
  2. Chua KP, Conti RM. Out-of-pocket Spending on Orphan Drug Prescriptions Among Commercially Insured Adults in 2014. J Gen Intern Med. 2019 Mar;34(3):338-340.
  3. Desai RJ, Sarpatwari A, Dejene S, Khan NF, Lii J, Rogers JR, Dutcher SK, RaofiS, Bohn J, Connolly JG, Fischer MA, Kesselheim AS, Gagne JJ. ComparativeEffectiveness of Generic and Brand-Name Medication Use: A Database Study of USHealth Insurance Claims. PLoS Med. 2019 Mar 13;16(3):e1002763.
  4. Fleischman W, Auth D, Shah ND, Agrawal S, Ross JS. Association of a RiskEvaluation and Mitigation Strategy Program with Transmucosal FentanylPrescribing. JAMA Netw Open. 2019 Mar 1;2(3):e191340.
  5. Gyawali B, Kesselheim AS. US Food and Drug Administration Approval of NewDrugs Based on Noninferiority Trials in Oncology: A Dangerous Precedent? JAMAOncol. 2019 Mar 28. [Epub ahead of print]
  6. Hernandez I, Good CB, Shrank WH, Gellad WF. Trends in Medicaid Prices, Market Share, and Spending on Long-Acting Insulins, 2006-2018. JAMA. 2019 Mar 25. [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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