Product safety has gone global. It is one of the byproducts of our growing global village. Despite the volume and variety of domestically produced products, U.S. consumers continue to show increasing demand for imported goods of all kinds. Since the U.S. Food and Drug Administration (FDA) has responsibility for ensuring the safety of most of the products Americans consume, the agency’s work has gone global. It is an expanding regulatory frontier.
In April 2012, FDA published a report, which documents how the agency works (through overseas inspections and collaborations with foreign governments) to ensure that the imported foods, medical products, and other goods it regulates meet the same high standards for safety and quality set for products manufactured domestically. One major area involves medical products.
The Global Drugstore
According to FDA, 40% of drugs (generic and prescription) consumed in the U.S. are manufactured outside of the U.S. Few countries, if any, have the same regulatory controls (including clinical review process, manufacturing and quality standards) that the FDA requires of U.S.-based manufacturers of the food and medical products it regulates.
Globalization of the medical product industry presents regulatory challenges from product development to final use by the consumer. For example,
- The clinical trials of all medical products required for FDA approval are increasingly conducted abroad, adding the complexity of the review process.
- Many U.S. consumers can purchase medicines via the Internet directly from foreign sources, increasing their potential exposure to unsafe or ineffective medical products.
- Many medical devices are sold in nearly identical forms around the world but are known by different trade names, making it difficult to warn medical professionals and consumers about potential dangers.
A Global Strategy
Recognizing the fact that globalization is not a transitory phenomenon, FDA has formulated a global strategy to increase its regulatory role in the international public health community. Some of the components of that strategy include:
- Opening new FDA posts overseas in key areas such as China, India, the Middle East, Europe, and Latin America. These help FDA build strong relationships with officials overseas and see first-hand how foreign-based facilities are operating;
- Developing strong and consistent international regulatory standards to allow countries to share a common foundation of science-based goals for product safety and quality. FDA’s Office of International Programs works with FDA’s centers and offices to share information, strategies and tools with other countries;
- Working with other countries to monitor, prepare for, and respond to public health challenges, such as pandemics (widespread epidemics of infectious disease), natural disasters or broad distribution of tainted FDA-regulated products;
- Working with international partners to advance the science used to assess the safety and effectiveness of regulated products, which can lead to more cost-effective and timely product development.
CLICK HERE for a copy of the bulletin that summarizes the report.
GO HERE to get a full copy of the entire Global Engagement report.
Copyright Rachel Agheyisi, Report Content Writer, and Regulatory Compliance Digest Blog
Filed under: Compliance Enforcement Activities, Consumer Protection Alerts, FDA Tagged: | FDA, Food & Drug Administration, global engagement, global health, product quality standards, product safety, public health
Reblogged this on Health and Medical News and Resources and commented:
” According to FDA, 40% of drugs (generic and prescription) consumed in the U.S. are manufactured outside of the U.S.”