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

By Ameet Sarpatwari, Charlie Lee, 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 July. The selections feature topics ranging from the price increases of protected-class drugs in Medicare Part D, to the impact of price regulation on the availability of new drugs in Germany, to the association between FDA advisory committee recommendations and agency actions. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Egilman AC, Wallach JD, Dhruva SS, Gonsalves GS, Ross JS. Medicare Spending on Drugs and Biologics Not Recommended for Coverage by International Health Technology Assessment Agencies. J Gen Intern Med. 2019 July 16. [Epub ahead of print]
  2. Feldman WB, Hey SP, Franklin JM, Kesselheim AS. Public Approval of Exception From Informed Consent in Emergency Clinical Trials:  A Systematic Review of Community Consultation Surveys. JAMA Netw open. 2019 July 3;2(7):e197591.
  3. Hwang TJ, Dusetzina SB, Feng J, Maini L, Kesselheim AS. Price Increases of Protected-Class Drugs in Medicare Part D, Relative to Inflation, 2012-2017. JAMA. 2019;322(3):267-269.
  4. Kashoki M, Hanaizi Z, Yordanova S, et al. A comparison of EMA and FDA decisions for new drug marketing applications 2014-2016: concordance, discordance and why. Clin Pharmacol Ther. 2019 July 15. [Epub ahead of print]
  5. Li DG, Najafzadeh M, Kesselheim AS, Mostaghimi A. Spending on World Health Organization essential medicines in Medicare Part D, 2011-15: retrospective cost analysis. BMJ. 2019 July 17;366:l4257.
  6. Rhee TG, Ross JS. Association Between Industry Payments to Physicians and Gabapentinoid Prescribing. JAMA Intern Med. July 2019. [Epub ahead of print]
  7. Sarpatwari A, DiBello J, Zakarian M, Najafzadeh M, Kesselheim AS. Competition and price among brand-name drugs in the same class: A systematic review of the evidence. PLoS Med. 2019;16(7):e1002872.
  8. Sarpatwari A, Kesselheim AS. Reforming the Orphan Drug Act for the 21st Century. N Engl J Med. 2019;381(2):106-108.
  9. Stern AD, Pietrulla F, Herr A, Kesselheim AS, Sarpatwari A. The Impact Of Price Regulation On The Availability Of New Drugs In Germany. Health Aff (Millwood). 2019 July;38(7):1182-1187.
  10. Zhang AD, Schwartz JL, Ross JS. Association Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008-2015. Milbank Q. July 2019. [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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