U.S. Agreement on Drug Safety

“Clinton Sells Out on Drug Safety� (by Henry Miller, Commentary, June 25) provides a wildly false and inflammatory picture of a recent package of “Mutual Recognition Agreements� negotiated between the European Union and the United States.

This package of agreements does represent a new way of doing business that is good for manufacturers, strengthens cooperation between U.S. and EU regulatory agencies and is fundamentally good for consumers on both sides of the Atlantic. Under this series of agreements, the U.S. will continue to exercise and enforce the highest standards of health and safety in the world. Our regulatory agencies, including FDA, retain full authority to keep products off the market for health or safety reasons.

The overriding benefit of the MRA package is that it will promote development of critical areas of the economy by eliminating duplicative testing requirements, so we can increase access to foreign markets without regulatory delays and at reduced costs. The industries covered under these accords--telecommunications, medical devices, pharmaceuticals, electronic equipment and recreational craft--are those where the U.S. is the most competitive in the world, so these agreements will create jobs at home and lower prices.

The pharmaceutical section of the MRA agreement contains explicit and detailed information-sharing and training requirements to ensure that EU pharmaceutical manufacturers meet all U.S. health and safety standards. The Food and Drug Administration must be fully convinced that all health and safety standards applied by the EU’s pharmaceutical industry meet our requirements, or products will not be allowed into the U.S.

CHARLENE BARSHEFSKY

U.S. Trade Representative

Washington