Monthly Round-Up of What to Read on Pharma Law and 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 February. The selections feature topics ranging from tertiary patenting of drug-device combinations; to off-label promotion and adherence to FDA guidelines among direct-to-consumer advertisements; to the impact of FDA label changes. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Beall RF, Kesselheim AS. Tertiary patenting on drug-device combination products in the United States. Nat Biotechnol. 2018 Feb 6;36(2):142-145.
  2. Bothwell LE, Avorn J, Khan NF, Kesselheim AS. Adaptive design clinical trials: a review of the literature and BMJ Open. 2018 Feb 10;8(2):e018320.
  3. Chang HY, Murimi I, Faul M, Rutkow L, Alexander GC. Impact of Florida’s prescription drug monitoring program and pill mill law on high-risk patients: A comparative interrupted time series analysis. Pharmacoepidemiol Drug Saf. 2018 Feb 28. [Epub ahead of print]
  4. Fralick M, Avorn J, Franklin JM, Abdurrob A, Kesselheim AS. Application and impact of run-in studies. J Gen Intern Med. 2018 Feb 15. [Epub ahead of print]
  5. Klara K, Kim J, Ross JS. Direct-to-Consumer Broadcast Advertisements for Pharmaceuticals: Off-Label Promotion and Adherence to FDA Guidelines. J Gen Intern Med. 2018 Feb 26. [Epub ahead of print]
  6. Powers JH, Evans SR, Kesselheim AS. Studying new antibiotics for multidrug resistant infections: are today’s patients paying for unproved future benefits? BMJ. 2018 Feb 22;360:k587.
  7. Sobel RE, Bate A, Marshall J, Haynes K, Selvam N, Nair V, Daniel G, Brown JS, Reynolds RF. Do FDA label changes work? Assessment of the 2010 class label change for proton pump inhibitors using the Sentinel System’s analytic tools. Pharmacoepidemiol Drug Saf. 2018 Feb 2. [Epub ahead of print]
  8. Wallach JD, Ross JS. Gabapentin Approvals, Off-Label Use, and Lessons for Postmarketing Efforts. JAMA. 2018 Feb 27;319(8):776-778.

Jeanne Lenzer on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

​We are joined by award-winning medical investigative reporter Jeanne Lenzer. We discuss her book, The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It. Lenzer puts forward strong arguments that the medical device industry is under-regulated, and that whistleblowers are insufficiently protected. Woven through her analysis is the story of one patient’s dangers and difficult journey involving an implanted device together. Related stories about physicians and researchers help leaven the medico-legal loaf with the human impact of this massive industry.

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 Apple Podcasts, listen at Stitcher Radio Tunein, or 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.