Washington — The flow of goods through international borders has grown much faster than the agencies that inspect and regulate foods and medicines, and a report from the influential U.S. Institute of Medicine (IOM) recommends that oversight of this trade must improve.
The report recommends that the U.S. Food and Drug Administration (FDA) work with comparable agencies and industry groups in other developed nations to adopt a mutual respect for inspections conducted by their counterparts. A system of shared standards and mutual recognition could help American and European agencies minimize wasteful duplicate inspections and focus more attention on inspecting greater numbers of manufacturing facilities, “especially when a vast number of facilities go uninspected,” according to the committee drafting the report.
The IOM report also sees a need for U.S. agencies to provide greater support to developing nations to improve their regulatory systems and build the technical training and tools needed for evaluation of pharmaceuticals and other consumable products.
This report is released just as U.S. media and regulators are trying to figure out how a counterfeit version of the cancer drug Avastin came into the United States and was administered to some cancer patients. The counterfeit is apparently not toxic, but has no active ingredient to treat cancer.
The case has focused attention on a weakness in global trading regulations that makes it difficult to trace a product back to its source.
The report recommends that FDA, the Centers for Disease Control and Prevention, the U.S. Agency for International Development (USAID) and the U.S. Department of Agriculture design programs to help developing nations build technical expertise in the regulation and inspection of pharmaceuticals and food products. It also recommends that over a three-to-five-year period, the agencies take a number of actions:
• Encourage the development of low-cost technologies to prevent fraud.
• Devise procedures by which inspection information can be shared by regulatory agencies in cooperating countries.
• Encourage international donor investment to help developing nations build greater capability in this area.
The Institute of Medicine also suggests that U.S. agencies create incentives for the private sector to invent inexpensive technologies that would be used to prevent and detect product fraud with a tracking system employed at various steps in a product’s supply chain.
The FDA sponsored the report from IOM and is already taking actions to tighten controls in the food and medical supply chain. The Secure Supply Chain initiative urges drug firms to keep track of their products from manufacturer to market, and rewards those firms with expedited transit through U.S. ports.
FDA announced April 4 that a China-based office has trained 1,600 regulators and manufacturers of export products on U.S. safety standards over the past two years. The agency began the training program several years ago after some contaminated Chinese products were detected in the U.S. market. Christopher Hickey, the head of the FDA’s 13-person staff in China, said, “The FDA’s China office represents a new era in cooperation between the United States and China on the safety of food and medical products.”
The China-based FDA office aims to increase the number of inspections at manufacturing plants; boost collaboration on product safety with other U.S. government agencies; and monitor events — such as an earthquake or other natural disaster — that could affect the safety or availability of FDA-regulated products.
Roughly 24 million shipments of FDA-regulated products were imported into the United States in 2011 from 228 foreign jurisdictions. This represents a fourfold increase over the past decade. An FDA news release says this steadily increasing volume of imports has made it more important than ever for FDA to build relationships with regulators and industry abroad.