US FDA aims to increase safety of imports
Sets out four-point plan of collaboration with other regulators worldwide
The US FDA has published a report outlining how it plans to minimise threats to public health and safety posed by rapidly rising imports of FDA-regulated products and a complex global supply chain.
The Pathway to Global Product Safety and Quality report lays out a long-term plan to deal with imports into the US, which have quadrupled since 2000. It says the US FDA would share more information with foreign counterparts as part of a multi-faceted strategy.
“We must work proactively and collaboratively to address the challenges we face,” said Margaret Hamburg, the FDA’s commissioner of Food and Drugs.
“The FDA must further collaborate and leverage in order to close the gap between our import levels and our regulatory resources. This report is an important step in ensuring we are able to fulfill our critical public health mission.”
The report outlines four key elements that are needed to make the change:
1. The FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality.
2. The FDA will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets.
3. The FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology.
4. The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk.
The new strategy also builds on changes already set in motion by the FDA. For example, the US regulator increased the number of foreign drug manufacturing inspections by 27% between 2007 and 2009 and has opened a series of international offices in key locations.
The FDA has also collaborated with its counterparts in the EU and Australia on drug inspections, worked to harmonise certain aspects of drug regulation via the International Conference on Harmonisation, and has joined the Pharmaceutical Inspection Cooperation/Scheme (PIC/S), which is an organisation of the drug manufacturing inspectorates from 39 countries. The FDA and other global leaders are also creating an expanded global regulators forum for medical devices.
The FDA is also broadening its food safety efforts under the FDA Food Safety Modernisation Act (FSMA). This new law creates a new foods safety system, in which FDA has a legislative mandate to require comprehensive preventive controls across the food supply chain and has new tools to hold players in the supply chain responsible. There are also new inspection mandates, including a mandate leading to the inspection of more than 19,000 foreign food facilities in the year 2016.
In addition, the FDA will establish a programme for qualified third parties to certify that foreign food facilities are in compliance with US requirements and can require certification as a condition of entry into the US.
