U.S. Should Bring Developing Nations on Board to Tackle Import Problems: Report
The FDA and other agencies must provide expertise, training and tools to developing nations to improve their medical technology monitoring practices and prevent dangerous medical products from entering the U.S., according to an Institute of Medicine (IOM) report. The recommendation is one of 13 suggested steps to strengthen regulatory systems abroad.
The FDA “cannot do its job well without substantial improvement in the capacity of its counterpart agencies in emerging economies,” the report states.
Unreliable transportation and communication systems; inadequate access to clean water, electricity and fast internet; and nonexistent, small or poorly equipped regulatory agencies are some of the barriers developing nations face, the IOM said. These safety obstacles can then become liabilities for the U.S., it adds.
Assistance to foreign countries could be provided directly or through international groups such as the World Health Organization, the IOM said. While there are more than 150 developing nations, the U.S. should pay particular attention to Mexico, Brazil, South Africa, India, Thailand and China, its major trading partners in the developing world.
The IOM outlines a list of minimum components for regulatory systems abroad. These include a method to identify when regulatory actions, such as an order to stop production due to unsanitary conditions, are necessary and a protocol for nations to share supply chain information.
The FDA and the U.S. Department of Agriculture should also provide incentives to those who develop inexpensive technologies to help prevent and detect fraud and track products throughout the supply chain, the IOM said.
In addition, incentives could be offered to importers that ensure their supply chains adhere to U.S. standards. The FDA’s secure supply chain pilot, which will reward firms that trace products from manufacture to U.S. entry, could be expanded to include more importers if initial results point to the program’s success, according to the report. The pilot was slated for launch early this year, but is still delayed, FDA spokeswoman Lisa Kubaska told D&DL.
International Collaboration Needed
The U.S. must also work with developed nations to improve safety, the report states. It urges the FDA to work with the EU, Canada, Japan, Norway, Iceland, Switzerland, Australia and New Zealand to mutually recognize one another’s inspections and eliminate duplicative effort. This is critical since many facilities currently go uninspected, the report states. The FDA is already working with Europe and Australia on several pilot inspection programs.
In addition, the IOM encourages industry, within the next three years, to develop a reliable method for sharing inspection results.
International supply chain worries have been a focus of Congress and the FDA in the past few years, especially where prescription drugs are concerned. President Barack Obama’s 2013 budget requests additional funding for the FDA to inspect facilities in China — a historically problematic area for medical imports. The agency currently has 13 field officers in China, where more than 1,600 manufacturers and regulators have received training on U.S. safety standards over the past two years.
The agency also has permanent foreign outposts in India, Belgium, England, Italy, Costa Rica, Chile, Mexico, South Africa and Jordan.
The report is available at www.fdanews.com/ext/files/04-06-12-IOM.pdf. — Sarah Karlin
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