Alliance Meets with Key Leaders of FDA’s International Programs and more
Advocacy at a Glance offers you the bullet point summary of current advocacy issues associated with the goals of the Alliance for a Stronger FDA.
Alliance Meets with Key Leaders of FDA’s International Programs. On Thursday the Alliance was pleased to hold a briefing with key officials from FDA’s International Office of International Programs including Lou Valdez, Associate Commissioner for International Programs and Director, Office of International Programs; Altaf Lal, Director of FDA’s India Office; and Chris Hickey, Director of FDA’s China Office. Lou and Altaf joined the Alliance membership participants in Washington while Chris participated in the briefing via video stream from China. The three FDA officials were joined on a panel with representatives from several of the Alliance’s membership organizations including Diane Dorman, Vice President for Public Policy, National Organization for Rare Disorders and President of the Alliance for a Stronger FDA; Chris Waldrop, Director, Food Policy Institute at Consumer Federation of America; Patrick Brady, Deputy Vice President, Scientific and Regulatory Affairs at PhRMA; and John Lewis, Vice President of Public Affairs at the Association of Clinical Research Organizations. The focus of the presentation was FDA’s key priorities and challenges in India and China. To view a piece Inside Health Policy did on the briefing please click here. Some of the highlights of the briefing included:
FDA Needs Continued Funding Increases to Carry out Its Growing Global Public Health Responsibilities. The FDA’s international public health challenges are growing exponentially and the agency needs continued funding increases to help address the complex global issues. Amongst examples of FDA’s recent international public health challenges, the tainted heparin recall in 2008 which originated in China and resulted in 149 deaths was raised.
FDA is Increasing Inspections Around the Globe. FDA is increasing the amount of inspections of food and medical products around the world in place like India and China. In India, the number of inspections in increased to 268 in 2012 from 221 the year before, with FDA's India office performing about a quarter of the inspections. In China, FDA performed approximately 70 inspections per year in fiscal years 2007 and 2008, and increased that number to about 190 per year after setting up the new China office
Challenges to Increasing Staff around the Globe: Visa Issues for FDA Inspectors in China. The U.S. government has not yet secured Chinese visas for additional FDA inspectors funded by a spending measure passed by congress earlier this year. At yesterday’s briefing Chris Hickey said the visa issue is being addressed at the “highest levels” of government and said that in the meantime the agency is sending inspectors on shorter stints in China, which could eventually help FDA to fill these positions permanently.
FDA has the Largest Number of US Government Employees in India. Currently FDA’s India office is comprised of six medical product inspectors, two food inspectors and three policy analysts, making FDA the largest US Government presence in the country according to personnel levels. The office expects to have 19 full-time employees when it is fully staffed.
Alliance Meetings with FDA’s Center for Drug Evaluation and Research and FDA’s Center for Biologics Evaluation and Research. As reported in last week’s update, on Friday of last week the Alliance met with members of FDA’s senior leadership teams at the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). Attached please find the slide presentations from the CDER meeting and the CBER meeting, respectively.