US Industry Urged To Back MRAs With EU

The Mutual Recognition Agreement initialled by the USA and the EuropeanUnion last spring is a good and flexible agreement in the interests of the USA, and provides a speedy mechanism if changes in the agreement are needed, Robert Dalton, assistant legal advisor in the Office of Treaty Affairs at the US Department of State, has told a US Food and Drug Law Institute conference.

It is remarkable and farsighted that states agree to recognize studies done by other states, he said. Allowing for conferences to deal with obstacles to the acceptance of performance assessment reviews, setting up committees for the agreement's effective functioning, and allowing for suspension of individual parts of it have great practical value. The World Trade Organization anticipated agreements such as MRAs, and provides for them, he added.

Richard Merrill, a law professor at the University of Virginia and former chief counsel to the Food and Drug Administration, said that while the FDA is within its authority to negotiate agreements within the MRA, how this translates operationally is another issue. In implementing the MRA, the FDA is bound by general laws applicable to federal regulatory agencies, including the Administrative Procedure Act, the Freedom of Information Act and the Federal Advisory Committee Act. The APA will determine whether what is agreed to is reconcilable with the Food and Drug Act, ie what can be agreed to in principle and what the FDA is obligated to implement domestically.