Interesting Developments in November

 I will be commenting soon on developments related to pharmaceutical patents and their significance for personalized medicine, but in this post I am briefly describing several interesting news items and articles from various media sources, and I am attaching links to the stories and articles.

1.  Jonathan Darrow has written a great article entitled Pharmaceutical Gatekeepers in the Indiana Law Review.  Darrow looks at the variety of actors in the drug-use decision-making process and their roles in the continued consumption of ineffective drugs.

http://mckinneylaw.iu.edu/ilr/pdf/vol47p363.pdf

2.  The Tufts Center for the Study of Drug Development has released its latest estimate of the cost of developing a new drug and, as always, the estimate, $2.6 billion, is a stunning one that has attracted widespread media attention.  I think the most nuanced mass media report on the study was written by Aaron E. Carroll and published in The New York Times on November 19th.

http://www.nytimes.com/2014/11/19/upshot/calculating-the-real-costs-of-developing-a-new-drug.html

3. The issue of clinical trial data sharing has been the focus of significant attention over the past several years.  In the November 27^th issue of The New England Journal of Medicine, Brian L. Strom et al published a report of the results of GlaxoSmithKline providing full access to its clinical trial data as of May 2013, and the NIH has proposed a new rule requiring increased access to clinical trial data summaries for all clinical trials.

            The Strom article is here:

            http://www.nejm.org/doi/pdf/10.1056/NEJMp1411794

            The NIH’s notice of its proposed rule is here:

            http://www.regulations.gov/#!documentDetail;D=NIH-2011-0003-0003

4.   Finally, the issue of pharmaceutical pricing continues to be in the news and on November 25th Robert Langreth of Bloomberg/BNA published an interesting article on pushback by Express Scripts and other pharmaceutical benefit managers (PBMs).  The PBMs are revising their formularies and their access requirements for specialty drugs in an effort to hold down costs. 

http://www.bloomberg.com/news/print/2014-11-25/more-medicine-goes-off-limits-in-drug-price-showdown.html

Pricing has been the biggest story in the pharmaceutical world in 2014, I expect that to continue in 2015.  The PBMs’ efforts to hold down prices and the soon to emerge marketplace for biosimilars in the U.S. will certainly be an interesting part of the pricing story.