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 January. The selections feature topics ranging from the contribution of new product entry versus existing product inflation in the rising cost of drugs, to an analysis of the proposed Medicare Part B to Part D shift, to patients’ perceptions of and responses to pill appearance changes for four chronic disease medications. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Fralick M, Sacks CA, Kesselheim AS. Assessment of Use of Combined Dextromethorphan and Quinidine in Patients With Dementia or Parkinson Disease After US Food and Drug Administration Approval for Pseudobulbar Affect. JAMA Intern Med. 2019 Jan 7. [Epub ahead of print]
  2. Hernandez I, Good CB, Cutler DM, Gellad WF, Parekh N, Shrank WH. The Contribution Of New Product Entry Versus Existing Product Inflation In The Rising Costs Of Drugs. Health Aff (Millwood). 2019 Jan;38(1):76-83.
  3. Hwang TJ, Jain N, Lauffenburger JC, Vokinger KN, Kesselheim AS. Analysis of Proposed Medicare Part B to Part D Shift With Associated Changes in Total Spending and Patient Cost-Sharing for Prescription Drugs. JAMA Intern Med. 2019 Jan 14. [Epub ahead of print]
  4. Kesselheim AS, Woloshin S, Lu Z, Tessema FA, Ross KM, Schwartz LM. Physicians’ Perspectives on FDA Approval Standards and Off-Label Drug Marketing. JAMA Intern Med. 2019 Jan 22. [Epub ahead of print]
  5. Lloyd JT, Maresh S, Powers CA, Shrank WH, Alley DE. How Much Does Medication Nonadherence Cost the Medicare Fee-for-Service Program? Med Care. 2019 Jan 22. [Epub ahead of print]
  6. Luo J, Khan NF, Manetti T, Rose J, Kaloghlian A, Gadhe B, Jain SH, Gagne JJ, Kesselheim AS. Implementation of a Health Plan Program for Switching From Analogue to Human Insulin and Glycemic Control Among Medicare Beneficiaries With Type 2 Diabetes. JAMA. 2019 Jan 29;321(4):374-384.
  7. Sarpatwari A, Gagne JJ, Lu Z, Campbell EG, Carman WJ, Enger CL, Dutcher SK, Jiang W, Kesselheim AS. A Survey of Patients’ Perceptions of Pill Appearance and Responses to Changes in Appearance for Four Chronic Disease Medications. J Gen Intern Med. 2019 Jan 10. [Epub ahead of print]
  8. Schwartz LM, Woloshin S. Medical Marketing in the United States, 1997-2016. JAMA. 2019 Jan 1;321(1):80-96.

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.

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.