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Commentary: The Curse of Too Much Caution
Henry Miller, M.S., M.D., Wall Street Journal, 11-26-04

Miller says that the FDA is a favorite target of Congress and the media because, as one former FDA commissioner puts it, the FDA is a “slow-moving target that bleeds profusely when hit.”

The current round of FDA bashing may be a prequel to yet more regulation of the pharmaceutical industry in pursuit of the holy grail of perfect drug safety. Miller takes issue with reflexive calls for greater regulation, wisely pointing out that “greater safety is not synonymous with greater regulation.” In fact, more regulation may lower the “net benefit” to patients and society because regulation is only designed to catch one type of error: the drug that is approved that should have been withheld or withdrawn.

When regulators approve a new drug that later proves unsafe, they will inevitably be excoriated by Congress, consumer groups, and the media. On the other hand, if they fail to approve an otherwise beneficial product, or drag out the approval process interminably, the guardians of public health will utter nary a peep. Says Miller, “the first kind of error is highly visible”, and thus correctible. The second is invisible and largely incorrectable.

In fact, not once in all its history has the FDA been investigated because it failed to approve a new drug. Miller concludes that a drug safety agency that only focused on killing unsafe drugs would make the FDA too risk averse, and keep valuable new drugs from ever reaching market.

Instead, he suggests an independent FDA ombudsman who would have the power to sanction the agency for both types of errors, thus ensuring that FDA has the right incentives to pursue safety and innovation simultaneously.

Project FDA.
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