From: ABA Journal
By Debra Cassens Weiss
A resolution passed by the ABA House of Delegates on Tuesday urges federal agencies to pursue regulatory cooperation with relevant foreign authorities.
The House passed Resolution 109B, which says the agencies should cooperate where appropriate and “consistent with their legal authority, statutory mandates, and regulatory missions.” The resolution states that U.S. agencies should work with their foreign counterparts to develop “common regulatory agendas, harmonized regulatory standards, information exchanges, and mutual recognition of tests and inspections.”
A report to the ABA House of Delegates says awareness and participation in foreign regulatory processes can help U.S. agencies maintain the safety of food and drugs and remove barriers to trade and exports.
According to the report, differing safety standards can create the potential for production errors as companies change their products to meet different regulations; can create higher costs for consumers; and can create concern for consumers who wonder why a foreign safety requirement isn’t applied to products purchased in their own country. Trade can also become more difficult when companies have to produce different food labels or change product design, depending on differing country requirements.
Cooperation could also allow U.S. and foreign agencies to pool resources, the report says. “For example, the FDA recently concluded a pilot project with European and Australian regulators to inspect manufacturing plants in China and other countries that manufacture active pharmaceutical ingredients. The agencies compared their lists of plants subject to inspection and the resources that each country had available, and where two or more agencies were scheduled to visit the same plant, the agencies agreed on one agency to inspect that plant or to do a joint inspection, and reallocated resources so that they could cover more plants. Building on the success of that pilot, the FDA is now pursuing a similar project with European regulators for site inspections of clinical trials.”
The report cites a new executive order signed by President Obama that endorses a cooperative approach recommended by the Administrative Conference of the United States.
