The FDA Waits for a New Head to Take the Heat

Is the Food and Drug Administration afraid to approve new drugs?

That's the bleak picture being painted by biotech and drug industry observers, who fear the absence of a chief drug regulator has played a role in a spate of recent rejections and delays. This should have investors on edge because nothing hurts drug and biotech stocks more than bad news from the FDA.

The FDA has been leaderless since Commissioner Jane Heaney resigned the day after President Bush's inauguration. With no one sitting in the FDA's big chair to make policy or to take the heat for controversial decisions, drug regulators appear to be in extra-strength career-preservation mode. With few exceptions, tough decisions on new drug approvals are being delayed or sent back to the companies for further study.

A Growing List of Applicants

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