Apr 21, 2011 (CIDRAP News) A 5-year strategic plan released yesterday by the US Food and Drug Administration (FDA) promises new approaches to food safety in line with new legislation and increased efforts to smooth the regulatory pathway for medical defenses against biological and other unconventional attacks.
The 58-page report, Strategic Priorities 2011-2015: Responding to the Public Health Challenges of the 21st Century, describes in broad terms how the FDA hopes to carry out its expanding mission over the next 5 years.
Because of globalization and technological advances, the FDA's job today is "fundamentally differentand far more complexthan it was even a few years ago," the report notes. The agency pledges it will fulfill its mission by "embracing innovation and actively pursuing partnerships with federal, state, and local agencies; international authorities; academia; non-government organizations; and the public sector."
The report emphasizes the huge increases in the flow of imported food, drugs, and cosmetics in the past decade. In 2010, more than 20 million "import lines" of products arrived in the United States, more than three times as many as 10 years ago. More than 300,000 facilities in 150-plus countries send products to the nation's roughly 300 ports of entry.
Meanwhile, the number of FDA import inspectors has changed very little. The figure is expected to climb a bit in the next year and reach 1,856 in fiscal year 2012, the report shows.
The number of imported food entries has doubled in the last 5 years, with more than 240,000 foreign establishments sending food to American shores, the FDA says. As has often been reported, the agency can physically examine only about 2% of the products exported by foreign food facilities.
With the new FDA Food Safety Modernization Act (FSMA) enacted, the FDA says the foundation of its food safety approach is to make sure preventive controls are in place from farm to table. It cites three long-term objectives:
- Establishing science-based preventive controls for the farm-to-table continuum (which was the topic of a stakeholder workshop the agency held yesterday
- Achieving high rates of compliance with preventive control standards,
- Ensuring adequate scientific capacity to support risk-based public health decision-making
Under the new food safety law, the FDA says it plans to "shift the burden of [food] import compliance from the limited FDA inspection force to importers and other stakeholders participating in the foreign food supply chain." The report also promises development of and training in new ways to inspect food.
On another topic, the report pledges that the FDA will work to improve the regulatory road for medical countermeasures (MCMs) against biological, chemical, radiological, and nuclear attacks. "The complex regulatory pathway required for approval of these types of medical products is one major contributing factor to the limited availability of MCMs," it says. Among the main examples of such MCMs are the US stockpiles of smallpox and anthrax vaccines.
The report outlines an "MCM Action Plan" with three pillars. First, to enhance the regulatory review processes, the FDA will set up "Public Health and Security Action Teams that will tackle the range of regulatory, scientific and policy issues facing MCM development and approval." The teams will work to en sure consistent regulatory approaches and use of best regulatory review practices.
The second piece of the action plan calls for advancing regulatory science for MCM evaluation by conducting research to find solutions to complex scientific regulatory problems, the report says.
The third component of the plan is to improve the legal, regulatory, and policy framework for effective public health responses. The agency plans to review "existing legal and policy approaches to MCM development, distribution, dispensation, post-use surveillance and data collection and, where needed, develop new approaches."
FDA Strategic Priorities report