Recent ICE Press regarding counterfeit of pharmaceutical drugs

This is a rough list of the recent ICE press releases mentioning counterfeit and pharmaceutical. It is quite clear that the overwhelming majority of counterfeit busts involve Viagra and other erectile dysfunction drugs, a problem that will probably resolve itself once the Pfizer patents on Viagra expire.

In my quick read of the ICE press releases, I found just 12 pharmaceutical counterfeiting cases in the ICE press releases from 2009 to May 2012, with 14 defendants.

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What’s a counterfeit? And how many counterfeit drugs are there?

Donald McNeil has an article in the New York Times that appeared in print on May 22, 2012 (page D6 of the New York edition) with the headline: “Malaria: Fake and Substandard Drugs Grow as Threat to Fight Disease.” A web version is available here: http://www.nytimes.com/2012/05/22/health/policy/fake-and-substandard-drugs-grow-as-threat-to-fight-malaria.html

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KEI Statement on WHA resolution on Consultative Expert Working Group on Research and Development: Financing and Coordination

KEI Statement on World Health Assembly resolution on Consultative Expert Working Group on Research and Development: Financing and Coordination

A number of developing countries worked together to push the World Health Assembly to create a member state process to consider the implementation of the CEWG. The most important CEWG recommendations are to begin work on a new WHO Convention on R&D financing, and to de-link R&D costs from drug prices.

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EU Statement at World Health Assembly on Consultative Expert Working Group Report

The EU has provided KEI with a copy of the EU statement delivered at the 65th World Health Assembly on Wed, May 23, 2012, on the WHO Consultative Expert Working Group on R&D Financing. In a nutshell, the EU position is to “generally support” the US led position, and to slow everything down. Here are some of the main points:

  • We recognise that current measures are insufficient, although we also cherish the collective efforts that have been made with respect to the issue so far.
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Obligations to fund R&D, under CEWG recommendation

The World Heath Organization is now debating proposal in a report form a Consultative Expert Working Group (CEWG) on R&D for a new medical R&D treaty, focusing on the special health needs of developing countries. The following table shows how much money various regions and countries would be obligated to spend on R&D, under the treaty proposal, which is .0001 of GDP, of which 20 percent would be invested through pooled funding mechanisms.

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BIO memo opposing transparency of drug development costs, sales, prices, and clinical trial outcomes

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.

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