US President Barack Obama signed a new Executive Order on 1 May that the White House hopes will promote international regulatory harmonization and reduce costly misalignments that stifle "economic growth, innovation, competitiveness and job creation."
"In an increasingly global economy, international regulatory cooperation, consistent with domestic law and prerogatives and U.S. trade policy, can be an important means of promoting" a least-burdensome approach to regulation, wrote Obama in an Executive Order entitled, Promoting International Regulatory Cooperation.
Office of Information and Regulatory Affairs (OIRA) Director Cass Sunstein supported the move in a piece accompanying the Executive Order, saying it will "eliminate unnecessary regulatory differences between the United States and other countries and by making sure that we do not create new ones."
While the US Food and Drug Administration (FDA) has been involved with regulatory harmonization efforts for some time now, including cooperation with the Global Harmonization Task Force, the International Medical Devices Regulator's Forum, the International Conference on Harmonization and others, the White House's Executive Order goes further.
"Today's Executive Order calls for, among other things, an interagency working group, chaired by OMB's Office of Information and Regulatory Affairs, to provide a forum to foster greater cooperation and coordination of U.S. Government strategies, including those for promoting regulatory transparency, sound regulatory practices, and U.S. regulatory approaches abroad," explained Sunstein.
Agencies will also be required to consider regulatory reforms to eliminate "unnecessary differences between the United States and its major trading partners," added Sunstein. Ironing out those differences might include the formation of best practices and aligning interests on emerging technologies, among other areas.
The Executive Order's requirement may change the status quo for FDA, which has operated with a fair amount of leniency in helping to develop international regulatory standards with other agencies and organizations.
The new model put in place by Obama's executive order calls for the working groups to be chaired by OIRA-not FDA or other federal agencies-and include representation from the Office of the US Trade Representative, with other agencies and offices to be included "as appropriate".
This language notably leaves out any mention of the agency that will ultimately carry out the regulations, leaving open the prospect that these working groups could issue opinions without having consulted with FDA.
The Executive Order does note that agencies will be required to submit to OIRA a Regulatory Plan with all international regulatory cooperation activities expected to lead to significant regulations, and that any recommendations put forth by the working parties must be done by a consensus opinion.
The working parties will also be prohibited from proposing any regulations already covered by existing agreements, such as those made between FDA and other international regulatory harmonization organizations, which could act as a barrier between the agency and the working parties.
Executive Order - Promoting International Regulatory Cooperation
White House - Reducing Red Tape: Regulatory Reform Goes International
Wall Street Journal - The White House vs. Red Tape
US Chamber of Commerce - US Chamber Welcomes Executive Order on International Regulatory Cooperation