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 September.

  1. Bouvy JC, Huinink L, De Bruin ML. Benefit-risk reassessment of medicines: a retrospective analysis of all safety-related referral procedures in Europe during 2001-2012. Pharmacoepidemiol Drug Saf. 2016;25(9):1004-14.
  2. Gupta R, Kesselheim AS, Downing N, Greene J, Ross JS. Generic Drug Approvals Since the 1984 Hatch-Waxman Act. JAMA Intern Med. 2016;176(9):1391-3.
  3. Kister I, Corboy JR.Reducing costs while enhancing quality of care in MS. Neurology. 2016 Sep 2. [Epub ahead of print]
  4. Kleijnen S, Lipska I, Leonardo Alves T, Meijboom K, Elsada A, Vervölgyi V, d’Andon A, Timoney A, Leufkens HG, De Boer A, Goettsch WG. Relative effectiveness assessments of oncology medicines for pricing and reimbursement decisions in European countries. Ann Oncol. 2016;27(9):1768-75.
  5. Lin D, Lucas E, Murimi IB, Jackson K, Baier M, Frattaroli S, Gielen A, Moyo P, Simoni-Wastilla L, Alexander GC. Physician attitudes and experiences with Maryland’s prescription drug monitoring program (PDMP). Addiction. 2016. [Epub ahead of print]
  6. Oye KA, Eichler HG, Hoos A, Mori Y, Mullin TM, Pearson M. Pharmaceuticals Licensing and Reimbursement in the European Union, United States and Japan. Clin Pharamcol Ther. 2016. [Epub ahead of print]
  7. Mailankody S, Prasad V. Thinking Systematically About the Off-Label Use of Cancer Drugs and Combinations for Patients Who Have Exhausted Proven Therapies. Oncologist. 2016;21(9):1031-2.
  8. Sanders GD, Neumann PJ, Basu A, Brock DW, Feeny D, Krahn M, Kuntz KM, Meltzer DO, Owens DK, Prosser LA, Salomon JA, Sculpher MJ, Trikalinos TA, Russell LB, Siegel JE, Ganiats TG. Recommendations for Conduct, Methodological Practices, and Reporting of Cost-effectiveness Analyses: Second Panel on Cost-Effectiveness in Health and Medicine. JAMA. 2016;316(10):1093-103.
  9. Xu J, Gill R, Cruz M, Staffa J, Lurie P. Effect of US Food and Drug Administration-Approved Pediatric Labeling on Dispensing of Extended Release Oxycodone in the Outpatient Retail Setting. JAMA Pediatr. 2016. [Epub ahead of print]

Lisa Ikemoto on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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Our guest this week is Lisa C. Ikemoto, the Martin Luther King, Jr. Professor of Law at UC Davis Law School. Lisa has written on specimen management, stem cell research, and many other topics in bioethics and health law and policy.

Our conversation included Lisa’s important insights on ways that race and gender mediate access to and impacts of biomedical technology use and health care.  Her recent work addresses reproductive tourism, the ways in which human gamete use links the fertility and biotechnology industries, and the privatizing effects of informed consent.  Lisa is a Bioethics Associate of the U.C. Davis Health System Bioethics Program, and a Faculty Associate of the U.C. Davis Center for Science and Innovation Studies.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw