What to Read on Pharma Law and Policy this Month

Ameet Sarpatwari Health Law Policy

By Ameet Sarpatwari, Michael S. Sinha, 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 July. The selections feature topics ranging from patent term restoration for top-selling drugs in the US; to the total cost of chimeric antigen receptor T-cell immunotherapy; to a review of exceptional responders to anticancer drugs. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Beall RF, Darrow J, Kesselheim AS. Patent term restoration for top-selling drugs in the USA. Drug Discov Today. 2018 Jul 25. pii: S1359-6446(18)30141-7. [Epub ahead of print].
  2. Chan HW, Russell AM, Smith MY. What is the quality of drug safety information for patients: An analysis of REMS educational materials. Pharmacoepidemiol Drug Saf. 2018 Jul 13. [Epub ahead of print].
  3. Gyawali B, Kesselheim AS. Reinforcing the social compromise of accelerated approval. Nat Rev Clin Oncol. 2018 Jul 3. [Epub ahead of print].
  4. Hernandez I, Prasad V, Gellad WF. Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy. JAMA Oncol. 2018 Jul 1;4(7):994-996.
  5. Liu P, Dhruva SS, Shah ND, Ross JS. Medicare Beneficiary Out-of-Pocket Costs for Generic Cardiovascular Medications Available Through $4 Generic Drug Discount Programs. Ann Intern Med. 2018 Jul 24. [Epub ahead of print].
  6. Mundkur ML, Franklin J, Huybrechts KF, Fischer MA, Kesselheim AS, Linder JA, Landon J, Patorno E. Changes in Outpatient Use of Antibiotics by Adults in the United States, 2006-2015. Drug Saf. 2018 Jul 9. [Epub ahead of print].
  7. Nishikawa G, Luo J, Prasad V. A comprehensive review of exceptional responders to anticancer drugs in the biomedical literature. Eur J Cancer. 2018 Jul 27;101:143-151. [Epub ahead of print].
  8. Puthumana J, Wallach JD, Ross JS. Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation. JAMA. 2018 Jul 17;320(3):301-303.

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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