Seeker Blog

Over the last two decades, Congress has expanded the FDA’s reach more than 127 times; it now oversees about 25 cents of every dollar spent in the U.S.

When does Congress legislate for less regulation?

The Science Board’s most important, and distressing, finding is that the FDA bureaucracy “cannot even keep up with the advances in science” — and not solely due to a lack of funding. While “the world of drug discovery and development has undergone revolutionary change,” the authors write, the FDA’s “evaluation methods have remained largely unchanged over the last half-century.” (Our emphasis.)

Think about that: We live amid a revolution in biology, but the FDA still thinks like it did when Sputnik launched.

…The real scandal is that these policies are the product of the FDA’s institutional culture, which puts political incentives and bureaucratic procedure above patient results. Congress and the press could do some good if they investigated that problem, but it’s so much easier to say, “spend more money.”

…The Science Board authors propose that the FDA “modernize current regulatory pathways,” especially the narrowness with which it balances risk and benefit for the most promising new therapies before they are allowed to reach the public.

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