Posts
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.
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.
3. The issue of clinical trial data
sharing has been the focus of significant attention over the past several
years. In the November 27th
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:
The
NIH’s notice of its proposed rule is here:
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.
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.
