Institute of Medicine Recommends Steps to Strengthen Global Drug Regulatory Systems

April 11, 2012 3:01 pm Topics: Counterfeit drugs and Federal regulations

A new report from the Institute of Medicine (IOM) recommends 13 steps FDA and other organizations can take to strengthen the drug and medical product regulatory systems in developing nations. “More than 80 percent of active pharmaceutical ingredients and 40 percent of finished drugs come from abroad,” notes a press release from the National Academies. Further, the press release stresses that the recent discovery of counterfeit Avastin in the US “underscores the challenges for U.S. regulators as imports increasingly dominate the American market.” Among other recommendations, the report encourages “the development of low-cost technologies to prevent fraud and assessing whether the pilot Secure Supply Chain program can be expanded.” The report also recommends that FDA and its counterpart agencies in the European Union, Canada, Japan, and other countries develop a system that includes “mutual recognition of one another's inspections.” More information is available in the National Academies press release, and the IOM report, “Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad,” may be downloaded from the National Academies Press Web site.