Statement of Sen. Bernard Sanders (I-VT) on the Mark-up of FDA Reauthorization Package

Posted on by James Love

This was the 3,500 word statement of Senator Bernie Sanders during Senate HELP committee markup of the PDUFA legislation. The statement covers a lot of ground, and illustrates why consumer groups love Bernie Sanders, while making one wonder why other Senators have not been more supportive of the consumer protection issues that Sanders discusses. Here are some highlights:

  • The proposal for a new extended monopoly for antibiotics and antifungal drugs is a “huge giveaway” that will lead to high prices and harm consumers.

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Senate HELP subcommittee hearings on S.1138, the HIV/AIDS prize fund

Posted on by James Love

Update: the hearing web page is here: http://www.help.senate.gov/hearings/hearing/?id=2d5dda75-5056-9502-5d1a-2a40d8a92d51

On May 15, 2012, the Primary Health and Aging Subcommittee of the Senate HELP Committee will hold hearings on S.1138, the Prize Fund for HIV/AIDS.

COMMITTEE ON HEALTH, EDUCATION, LABOR AND PENSIONS
Primary Health and Aging Subcommittee

HEARING NOTICE

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WTO disputes- Intellectual property dimensions of the Boeing case (WT/DS353)

Posted on by Thiru

“Roma locuta causa finita est” (Rome has spoken, therefore the case has been decided) was the maxim employed by medieval jurists to describe the absolute irrevocability of papal judgements in canon law. Today, in modern international trade law, the World Trade Organization’s (WTO) Appellate Body fulfills a similar function as the international trading system’s “Supreme Court”. In the words of the WTO,

[t]he Appellate Body was established in 1995 under Article 17 of the Understanding on Rules and Procedures Governing the Settlement of Disputes (DSU). Continue Reading →

Is the WHO CEWG proposal for the R&D treaty “too small”?

Posted on by James Love

The WHO’s Consultative Expert Working Group (CEWG) on R&D proposal for a new WHO Convention on health R&D has been widely praised by public health groups (See https://www.keionline.org/node/1399). The CEWG proposal for a treaty has also, at least so far, avoided much criticism from the pharmaceutical industry, even though it strongly embraces the notion of delinkage of R&D costs from product prices, open innovation, and technology transfer and capacity building in developing countries. Continue Reading →

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Senate HELP Committee proposes evaluation of Innovation Inducement Prizes, as alternative to product monopolies

Posted on by James Love

In the United States Senate, the Committee on Health, Education, Labor and Pensions (HELP) is trying to move forward a bill titled the “Food and Drug Administration Safety and Innovation Act.” Among other things, the bill would “amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, establish user-fee programs for generic drugs and biosimilars,” and address a number of other topics, such as extend the legal monopoly on antibiotic drugs by 5 years. Continue Reading →

5 April 2012: World Health Organization’s Consultative Expert Working Group on R&D Financing releases its Report

Posted on by Thiru

On Thursday, 5 April 2012, the World Health Organization released the report of the Report of the Consultative Expert Working Group on Research and Development: Financing and Coordination entitled “Research and Development to Meet Health Needs in Developing Countries: Strengthening Global Financing and Coordination”. The 218 page report will take some time to fully assess.

The report can be found here: http://www.who.int/phi/CEWG_Report_5_April_2012.pdf

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