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The FDA tries to do too much

May 27, 2008

Re "A healthier FDA," editorial, May 22

A case could be made that the U.S. Food and Drug Administration is hopelessly swamped. But one reason is that whenever the FDA's reach exceeds its grasp, it seeks to do more.

When it takes years to achieve certainty about the efficacy of a new drug -- sometimes while terminally ill patients are not allowed to use the drugs -- the FDA loses sight of safety issues, which require a different set of priorities and use of resources, not more staff. The FDA's usual response to safety failures is to demand more power to control additional products, such as vitamins and supplements.

The FDA cannot hire a large enough army of inspectors to visit every foreign drug manufacturer and supplier with adequate frequency or effectiveness. It should not try. U.S. drug companies must take on most responsibility for such inspections, and if the FDA must do spot checking, testing can be done once drugs arrive in the U.S.

Richard E. Ralston

Executive Director

Americans for Free Choice

in Medicine

Newport Beach

Leadership is all about setting priorities, because revenues always fall short of needs. The inspection rate for foreign-produced food and drugs is pitifully inadequate.

FDA Commissioner Andrew C. von Eschenbach told Congress that his agency could use another $275 million a year to keep our food and drugs safe for consumption. For perspective, that is a little more than the cost of a single day of the Iraq war.

Ensuring the safety of our food and drugs should be a priority. Congress needs to resist the pharmaceutical companies' efforts to dampen the FDA's effectiveness.

Larry Donohue MD

Seattle

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