Senate Approves President's Nominee to Head the F.D.A.

By THE ASSOCIATED PRESS

ASHINGTON, Oct. 17 — The Senate today approved President Bush's nominee to head the Food and Drug Administration.

On a voice vote, the senators approved Dr. Mark B. McClellan, a physician and an economist who is one of Mr. Bush's top advisers on health policy.

"Dr. McClellan has the training, the experience and the stature to serve as the head of the country's most important public health regulatory agency," said Senator Edward M. Kennedy, the Massachusetts Democrat who is chairman of the Health, Education, Labor and Pensions Committee.

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The F.D.A., whose 10,000 employees regulate medical treatments, food and cosmetics, has been without a commissioner since Mr. Bush took office. In nominating Dr. McClellan, the president told him to pay special attention to protecting the nation from bioterror, speeding patient access to breakthrough therapies and making those therapies safer.

The Senate also passed without debate today a bill that requires the manufacturers of medical devices to pay tens of thousands of dollars in new user fees in return for speedier government review of their products.

The House passed the bill on Wednesday. It now goes to Mr. Bush.

The proposal mirrors an existing system of user fees paid by drug companies for speedier reviews of medications by the food and drug agency.

Under the bill, manufacturers of medical devices like catheters, pacemakers and M.R.I. machines would pay more than $25 million in fees over the next year. In exchange, the government would hire more staff members and improve procedures to allow for speedier product reviews.

Lawmakers agreed on third-party inspections of manufacturing companies and plants. Many companies had argued that they should be able to hire third-party companies to inspect their plants, rather than undergo numerous inspections to satisfy federal and foreign requirements. Some lawmakers had concerns that such a system would have too little oversight.

The compromise narrows that provision to apply to companies that do business overseas. It also includes civil and criminal penalties for third-party reviewers that are fraudulent or withhold information from the government.