By: Mary Lou Valdez
If it takes a village to raise a child, in today’s economy it takes the support and commitment of a global community to ensure the safety of the food we eat and the medications we rely on.
This point was made clear in an Institute of Medicine report released on April 4. The report was commissioned by the FDA as the agency addresses the challenges of global supply chains, international trade, and foreign sourcing of foods, feeds, and medical products. It complements the FDA Commissioner’s Report on Global Pathway to Product Safety and Quality released last summer.
Imports of food and drug products regulated by FDA have increased by more than 13 percent per year since 2002, resulting in a four-fold increase of products produced outside of the United States. Approximately 50% of the fresh fruits and 20% of fresh vegetables, as well as 80% of seafood consumed in America comes from abroad. Similarly, more than 80 percent of the active pharmaceutical ingredients used to make medicines are imported. To ensure that the vast array of products Americans depend on are safe, FDA focus can no longer be solely domestic – it must be global.
Since many of the products imported are from emerging and developing countries, the FDA asked the IOM to take a look at the regulatory systems in those countries to identify major gaps and to design a strategy for how the FDA, along with other regulators and stakeholders, can help to strengthen their regulatory systems and build capacity.
Not surprisingly, the IOM found that the hurdles are great in some countries where there is inadequate clean water, electricity, transportation, communication systems and Internet access. Their regulatory agencies often operate with a skeletal staff, outdated equipment and limited or non-existent surveillance systems. In some of the least resourced countries there are weak or no laws governing product safety while product safety is not a high priority in others.
The IOM Committee’s strategy was to focus on the nexus of public health, product safety, development and trade, while recognizing that regulatory systems play an important role. The IOM identifies several core elements of a regulatory system: they must be responsive, outcome-oriented, predictable, risk-based or proportionate and independent. Other important commonalities include an enterprise risk management approach to regulation; focus on securing the entire supply chain; develop a profession of regulators – an “esprit de corps”; and make accountability an essential element of their system. The IOM also acknowledges that industry must play a role in ensuring the safety of its imported products.
To help build regulatory capacity, the IOM recommends that the FDA, other federal agencies and international organizations provide technical expertise, training and tools to strengthen the surveillance system in developing countries.
We take pride in the efforts FDA already has undertaken to support and collaborate with regulatory systems across the globe, such as our foreign training programs on good clinical practice inspections and low acid canned food inspections; a medical products information “hub” for the Americas in collaboration with the Pan American Health Organization; our interagency agreements with the US Agency for International Development to better understand pharmacovigilance systems in Africa and Asia; and our involvement with the World Bank’s Global Food Safety Fund, a partnership of public and private organizations intended to boost food safety capacity around the world. And this is only a short list of our activities.
We welcome the IOM’s call to international and intergovernmental organizations to invest more in strengthening the capacity of regulatory systems in developing countries, and to track progress as a priority of development banks, regional economic communities and public health institutions.
We were pleased that the IOM supports the agency’s risk-based strategy for monitoring and inspecting imported products and recommends that the agency extend this approach by working with strong regulators in other countries to plan inspections and pool data.
However, additional legal authorities would be helpful to accomplish this goal. FDA currently is barred from sharing certain non-public information with other regulatory agencies that might lead to timely identification, prevention, and resolution of emerging threats. Nor do we have the authority to use foreign audit data collected by our foreign regulatory counterparts with strong regulatory systems that would better leverage our limited resources.
Other authorities would be helpful to help us better manage risks. These include the ability to refuse admission of a product if inspection of the manufacturing facility is delayed, limited, or denied; and allow FDA to destroy the low value but large number of unsafe drugs that are coming into the country through international mail, typically purchased over the internet. In order to enhance our risk data, we would like additional information such as unique facility identifier as a condition of registration and import that would make it easier for FDA to properly follow a threat through the supply chain.
To ensure that industry assumes appropriate responsibility for their imported product, it would be helpful for manufacturers to account for the quality and origins of the materials that go into their products and require that manufacturers provide complete information to FDA on threats to the drug supply chain. Furthermore, the use of accredited third parties that meet prescribed standards could provide an additional set of eyes to help ensure the safety of the drug supply chain.
Ensuring the safety of imported food and medicines takes all countries working together, including governments, industry, academia, and other stakeholders. But marshalling the forces of this vast community may not be enough to provide the robust regulatory system we need in today’s global marketplace without new authorities to protect the health of the American public.