|April 26, 2012|
Previously published on April 2012
On April 23, 2012, the Food and Drug Administration (FDA) issued a report on the FDA's plans for increased global engagement. The report focuses on the challenges which a U.S. domestic regulatory agency faces in protecting U.S. consumers who are increasingly using products from non-U.S. manufacturers and facilities.
The report begins by noting the enormous volume of imports of FDA-regulated products. In 2009, for example, “$2 trillion worth of FDA-regulated products manufactured in more than 300,000 foreign facilities entered the United States from more than 150 countries.” Between 2002 and 2011, imports of FDA-regulated products have grown substantially. This increase in imports results in, as the report states, “increased potential risks to the U.S. public.”
In addition to the large volume of imports of FDA-regulated products, including food and medical products, the report observes that “[t]he increasing number of [medical product] clinical trials conducted abroad adds to the complexities of FDA reviews of product applications.” These clinical trials are often conducted in "nations with limited regulatory capacity.”
The FDA’s global engagement strategies include the following:
- The FDA has opened offices in China, India, Latin America, Europe, South Africa, and the Middle East. Through these offices, the FDA seeks greater knowledge of the regulatory systems of other countries, fosters relationships with other regulators and develops information for inspection of foreign facilities.
- The FDA proposes to work with the governments of other countries to strengthen their regulatory systems in recognition of the stake which the FDA and U.S. consumers have in the regulatory systems of other countries.
- The FDA recognizes the need for greater harmony in global science-based regulatory standards.
- Because inspection resources are limited, the FDA is focused on developing tools to effectively identify the products which pose the greatest health risks.
Regulated industry faces issues which mirror those which the FDA is facing. Industry shares the FDA’s interest in safe products irrespective of the product’s country of origin. The challenge for industry is finding effective ways to work with the FDA and regulators in other countries to build an effective and reasonably efficient global regulatory system. If achieved, products can move across borders and be consumed in the U.S. and elsewhere with confidence that the products are safe and are what they purport to be.