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, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of April. The selections feature topics ranging from the effect of direct-to-consumer advertising on asthma medication sales, to the impact of FDA approval of Colrys on patient initiation of and spending on colchicine products, to the reasons why certain new drugs required multiple review cycles.  A full posting of abstracts/summaries of these articles may be found on our website.

  1. Cho MK, Magnus D, Constantine M, Lee SS, Kelley M, Alessi S, Korngiebel D, James C, Kuwana E, Gallagher TH, Diekema D, Capron AM, Joffe S, Wilfond BS. Attitudes Toward Risk and Informed Consent for Research on Medical Practices: A Cross-sectional Survey. Ann Intern Med. 2015 Apr 14. [Epub ahead of print]
  2. Daubresse M, Hutfless S, Kim Y, Kornfield R, Qato DM, Huang J, Miller K, Emery SL, Alexander GC. Effect of Direct-to-Consumer Advertising on Asthma Medication Sales and Healthcare Utilization. Am J Respir Crit Care Med. 2015 Apr 16. [Epub ahead of print]
  3. Goldacre B. How to get all trials reported: audit, better data, and individual accountability. PLoS Med. 2015 Apr 14;12(4):e1001821.
  4. Kesselheim AS, Franklin JM, Kim SC, Seeger JD, Solomon DH. Reductions in Use of Colchicine after FDA Enforcement of Market Exclusivity in a Commercially Insured Population. J Gen Intern Med. 2015 Apr 9. [Epub ahead of print]
  5. Light DW, Lexchin J. Why do cancer drugs get such an easy ride? 2015 Apr 23;350:h2068.
  6. McClellan MB, Daniel GW, Dickson D, Perlmutter J, Berger DP, Miller V, Nussbaum S, Malin J, Romine MH, Schilsky RL. Improving evidence developed from population-level experience with targeted agents. Clin Pharmacol Ther. 2015 May;97(5):478-87. Epub 2015 Apr 3.
  7. Ross JS, Dzara K, Downing NS. Efficacy and safety concerns are important reasons why the FDA requires multiple reviews before approval of new drugs. Health Aff (Millwood). 2015 Apr 1;34(4):681-88.
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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