Senator Sanders has offered an amendment to the Food and Drug Administration Safety and Innovation Act of 2012 that would require drug sponsors to disclose the costs of pre-clinical research, clinical trials and related R&D, as well as grants, economic incentives that subsidize drug development costs, and also report quarterly sales and revenues, register all clinical trials at www.clinicaltrials.gov, and report detailed descriptions of each clinical trial participant’s results.

During the week of 14 May 2012, the Republic of Kenya submitted a resolution to the 65th session of the World Health Assembly entitled, "WHO Convention on Research and Development Financing and Coordination". The resolution will be published by the World Health Organization (WHO) as a conference paper for discussion in Committee A under agenda item 13.14 Consultative Expert Working Group on Research and Development: Financing and Coordination. It is expected that this agenda item on the CEWG will be brought forward for early discussion at the Assembly.

This is the latest draft of my written testimony for the May 15, 2012 Senate HELP hearings on S.1138, the Prize Fund for HIV/AIDS.

Some additional relevant data are available on the following pages

http://keionline.org/prizes
http://keionline.org/hiv

The World Intellectual Property Organization (WIPO) will convene the 18th session of the WIPO Standing Committee on the Law of Patents (SCP) from 21 May 2012 to 25 May 2012 (during the same week as the 65th session of the World Health Assembly). The agenda of the SCP is reproduced below.

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.

Manon Ress obtained the following quotes for various antiretroviral drugs on May 9, 2012.

The products are described briefly in the following chart, which provides details on the recommended dose: http://www.aidsmeds.com/articles/DrugChart_10632.shtml

The FDA web page on Antiretroviral drugs used in the treatment of HIV infection: http://www.fda.gov/ForConsumers/byAudience/ForPatientAdvocates/HIVandAID...

The prices were obtained from http://www.goodrx.com/. for pharmacies in or near Arlington, Virginia or Washington, DC.

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

Title: The High Cost of High Prices for HIV/AIDS Drugs and the Prize Fund Alternative
Date: Tuesday, May 15, 2012
Time: 10:00 a.m.
Place: SD-430

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 http://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.

The USTR's 2012 Special 301 list was published on April 30, 2012. Below are some comments about certain portions of the Special 301 Report that concern access to knowledge and access to medicines.

USTR cites the "TEAM" approach to access to medicines

The 2012 USTR Special 301 Report was published on April 30, 2012. The report details USTR's unilateral standards for the granting and enforcement for a diverse set of intellectual property rights, and singles out countries that USTR claims do not meet those standards. The Report places the offending countries into different categories, including those on the “Priority Watch List,” the “Watch List” and those to have a “Special 306” review. According to USTR:

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.

On Wednesday, April 25, 2012 at 10:00 AM, the Senate Health, Education, Labor and Pensions (HELP) Committee will have an executive session to do a markup of FDA bills.

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 (CEWG) entitled "Research and Development to Meet Health Needs in Developing Countries: Strengthening Global Financing and Coordination".

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

On Friday, March 30, 2012, Senator Tom Harkin (D-IA), Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee sent a letter to President Obama supporting an international treaty for persons who are visually impaired or have other disabilities. The letter urges the Obama administration to achieve several goals in such a treaty, including robust minimum standards that do not diminish the rights provided for under U.S.