Compulsory Licensing of Drugs

Texas Congressman Doggett was one of the legislators who asked the NIH to consider submitting so-called “march-in” petitions to the FDA, and has followed up with HHS Secretary Burwell. Individual patients and patient groups have submitted march-in petitions, which the FDA has never granted. The NIH has never submitted a march-in petition.

I have followed compulsory licensing in India for years with great interest as a model for the US and other nations whose governments and citizens are finding the costs of drugs an unreasonable budget burden. India is heavily criticized by the pharmaceutical industry for “violating intellectual property rights,” and compulsory licensing of drugs is what that phrase refers to when the US Trade Representative uses it during treaty negotiations such as the recent TPP and TRIPS in the more distant past.

The NIH [sic; FDA] “in 35 years has never agreed with a request for march-in rights, particularly in the context of high drug prices,” Dr. Aaron Kesselheim, an associate professor of medicine at Harvard Medical School, told FiercePharma last month.

Burwell says HHS is considering ‘march-in’ on skyrocketing drug prices
Emily Wasserman, www.fiercepharma.com

Interestingly to probably only me, my most viewed blog post ever refers to this topic. Capsules of anagrelide remain in short supply as of this date, 20160212. I wrote the blog post on 20150123.