Author: James Love

In 2011, the FDA told the NIH it could use enforcement discretion to permit importation and sale of unregistered drugs

In 2011, in the context of a shortage of Fabrazyme, the FDA told the NIH if they could “in theory” allow Shire to import and sell Replagal, a drug approved for sale in Europe, but not in the United States, as an unregistered biologic substitute. The remedy explored for the Fabrazyme shortage may be the best way to address a different problem, the price gouging associated with the drug Daraprim (generic name: pyrimethamine).

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Statement of KEI on announcement that there is a consensus on the Trans Pacific Partnership (TPP) trade agreement
October 5, 2015, 10am, EST

These comments by James Love, KEI Director

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On September 28, 2012, nearly three years ago, KEI submitted a FOIA request to USTR for “all documents relating to the World Health Organization (WHO) consideration of an agreement or treaty to support medical R&D.”

Three years later USTR has released 89 pages of documents, with some redactions. But USTR also withheld 64 documents pursuant to FOIA exemption 552(b)(5) and three documents pursuant to FOIA exemption 552(b)(1).

• USTR Cover letter

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On June 4, 2015, KEI asked USTR to provide the names of the TPP Chapters. The contents of the chapters are all officially secret, but we thought the names of the chapters should be public, and made a request for the chapter names under the Freedom of Information Act (FIOA). Today, more than 3 months later, USTR has responded to that FOIA. According to USTR, as of September 10, 2015, the names of the TPP Chapters are as follows:

1. Intial Provisions and General Definitions
2. Trade in Goods
3. Textiles and Apparel
4. Rules of Orgin

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KEI TPP Briefing Note: Conflicts with US legal norms and TPP Article QQ.H.4: {Civil Procedures and Remedies / Civil and Administrative Procedures and Remedies} (*based upon May 11, 2015 TPP negotiating text.
Draft September 9, 2015

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These were comments KEI provided to the Medicines Patent Pool (MPP), for its consultation on expanding the mandate to include drugs to treat the hepatitis C virus.

To: consultation@medicinespatentpool.org.
Date: August 28, 2015
Re: Comments by James Love on behalf of KEI for the consultation regarding the MPP mandate to expand into HCV (and other diseases).

KEI has submitted joint comments with UAEM in this consultation. Here on behalf of KEI I make a few additional points.

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Five groups, the Authors Alliance, Creative Commons, the Electronic Frontier Foundation (EFF), Knowledge Ecology International (KEI) and New Media Rights have written to Ambassador Froman at USTR, asking that the TPP not adopt measures that would prevent the Congress from enacting legislation to limit the remedies for copyright infringement that were proposed by the Register of Copyrights in June 2015, to expand access to orphan copyrighted works.

A copy of the letter is available here:

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