This week The U.S. Food and Drug Administration (FDA) is making moves to enforce the April signed Food Modernization Act in an attempt to cap a problem in which much of the foodstuffs in American homes are unhealthy due to the lack of funding and empowerment of the FDA to do more through investigations of food plants, and the ability to swiftly implement recalls when necessary. The legal drug importation process will also be affected.

Commissioner of Food and Drugs Margaret A. Hamburg, M.D. stated:

“Global production of FDA-regulated goods has exploded over the past ten years. In addition to an increase in imported finished products, manufacturers increasingly use imported materials and ingredients in their U.S. production facilities, making the distinction between domestic and imported products obsolete. There has been a perfect storm – more products, more manufacturers, more countries and more access. A dramatic change in strategy must be implemented.”

The FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality. The coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets.

Hamburg continues:

“FDA regulated imports have quadrupled since 2000. The FDA and our global regulatory partners recognize this new reality and realize we must work proactively and collaboratively to address the challenges we face. 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.”

Western economies will increase their productivity to compete with emerging markets and economies, leading to more imports and increased pressure to reinvent manufacturing processes. Money, goods, data and people will increasingly and more quickly cross borders. Today, a typical U.S. manufacturing company relies on more than 35 different contract manufacturers around the world.

FDA has also collaborated with its counterparts in the European Union and Australia on drug inspections, worked to harmonize certain aspects of drug regulation via the International Conference on Harmonization, and joined the Pharmaceutical Inspection Cooperation/Scheme (PIC/S) which is an organization 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.

Acting Principal Deputy Commissioner of Food and Drugs John M. Taylor, J.D. adds:

“In order to cope with the fundamental global shifts on the horizon, the FDA will have to substantially and fundamentally revise our approach to global product safety. We can no longer rely on historical tools, activities and approaches. Implementing this strategy is vital to the public health.”

Processors of all types of food will also now be required to evaluate the hazards in their operations, implement and monitor effective measures to prevent contamination, and have a plan in place to take any corrective actions that are necessary. Also, the FDA will have much more effective enforcement tools for ensuring those plans are adequate and properly implemented, including mandatory recall authority when needed to swiftly remove contaminated food from the market.

The FDA will also for the first time have a congressional mandate for risk-based inspection of food processing facilities. For example, all high-risk domestic facilities must be inspected within five years of enactment and no less than every three years thereafter.

The legislation significantly enhances FDA’s ability to oversee the millions of food products and drugs coming into the United States from other countries each year.

Source: The U.S. Food and Drug Adminstration

Written by Sy Kraft