Response by FDA to KEI’s FOIA Request Regarding the PSM India Summit of May 11, 2010 in New Delhi

In June of 2010, KEI was informed that representatives from the the United States Food and Drug Administration (FDA) had recently attended a summit in India on the issue of counterfeited and spurious medicines organized by the Partnership for Safe Medicines (PSM), a US-based organization with clear links to pharmaceutical corporate interests.

In July of 2010, KEI submitted a Freedom of Information Act (FOIA) request to the FDA regarding this PSM “India Collaboration Summit” held in Delhi, India, on May 11th, 2010, in order to increase transparency about these events and their agendas.

The FDA’s response was received on October 1st 2010. The response revealed that FDA attendees included Bruce Ross (the FDA Country Director for India), Regina Brown (the Assistant Country Director), and Nirupa Sen (the Food and Medical Product Safety Coordinator). Other attendees included representatives of consumer groups, pharmaceutical producers (OPPI), and academics and medical institutions (AIIMS). From the Government of India, Joint Secretary Arun Jha of the Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals, was in attendance. The FDA did not make any presentations at the meeting, though a brief introductory comment was made by Bruce Ross about their India Office. The reply stated that no contracts or Memorandums of Understanding (MOUs) were signed “before, at, or following the meeting.” It also stated that no other events were presently planned between the FDA and PSM.

According to the agenda received by KEI in the FOIA request, the objectives of the “summit” included: “rais[ing] awareness of harms to safety” by counterfeit medicines, as well as “informing” the medical and healthcare communities as well as consumers about their risks. The primary objective, however, appeared to be the creation of a “PSM India” (PSM-I), including developing a Memorandum of Understanding with the Government of India and discussing PSM-I’s “logistical and financial needs.”

The documents revealed that PSM hopes to have a PSM-I set up by Q4 2010, and wanted to use the meeting to give an overview of PSM-I’s intended activities and materials and discuss to which groups each of PSM-I’s actions should be targeted.

The materials received included a large number of PSM promotional materials, including the slide presentation of its Executive Director, Scott A. LaGanga, presented during the Welcoming and Opening Remarks of the Summit. The slide presentation gave a basic introduction to PSM, its key messages and core principles, its members, Board, and outreach activities, its website, SafeMeds communiques (weekly updates and email alerts), its materials for the public, for pharmacists and healthcare professionals, and for policymakers (including PSM’s “guide to protecting the supply chain, regulating online sales, and combating counterfeit drugs” and monthly Congressional Update emails), as well as descriptions of some of its international efforts. This included a description of its “Recent Outreach and Progress in India,” where the slides said that PSM has conducted more than 30 meetings in India during the last year, and a slide entitled “Next Steps,” where PSM presented plans to launch a “Public Private Partnership modeled after PSM.” A proposed 2010 budget for PSM-I was also received by KEI in the FOIA response.

Other promotional documents received by KEI in the FOIA response included a copy of the PSM Pamphlet “Safe Savings,” and copies of the following one-to-two-page PSM information sheets: “International Principles for Drug Safety,” “International Affiliate Benchmarks,” “8-Step Checklist for Medicine Safety” (S.A.F.E.D.R.U.G.), the PSM Weekly Update for the week of March 29, 2010, “How to Start a Partnership for Safe Medicines,” “About the Partnership,” “North American & European Partners,” “SafeMeds Resources,” “The Development of PSM India” and “How to Launch a Partnership for Safe Medicines Alliance.”