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 April. The selections feature topics ranging from the effect of a shortage of baclle Calmette-Guérin (BCG) on treatment costs for bladder cancer, to a comparison of regulatory review of new therapeutic agents by the FDA and the EMA, to the impact of CVS pharmacy’s discontinuance of tobacco sales on cigarette purchasing. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Davies BJ, Hwang TJ, Kesselheim AS. Ensuring Access to Injectable Generic Drugs – The Case of Intravesical BCG for Bladder Cancer. N Engl J Med. 2017;376(15):1401-3.
  2. Downing NS, Zhang AD, Ross JS. Regulatory Review of New Therapeutic Agents – FDA versus EMA, 2011-2015. N Engl J Med. 2017;376(14):1386-7.
  3. Fralick M, Kesselheim AS. FDA Approval of Desmopressin for Nocturia. JAMA. 2017 Apr 6. [Epub ahead of print]
  4. Gyawali B, Prasad V. Drugs that Lack Single-Agent Activity: Are They Worth Pursuing in Combination? Nat Rev Clin Oncol. 2017;14(4):193-4.
  5. Polinski JM, Howell B, Gagnon MA, Kymes SM, Brennan TA, Shrank WH. Impact of CVS Pharmacy’s Discontinuance of Tobacco Sales on Cigarette Purchasing (2012-2014). Am J Public Health. 2017;107(4):556-62.
  6. Sharfstein J. Déjà Vu at the FDA. Milbank Q. 2017 Apr 4. [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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