The FDA’s Power Grab

The U.S. Food and Drug Administration (FDA), using the media as its voice, provides us with alarmist and unhelpful messages about medicines all the time. These messages reflect a subtle type of bias—that any drug not specifically evaluated by the FDA must be unsafe. And the awful result is that there are fewer safe drugs on the market and more-expensive drugs overall.

The FDA is making it hard for manufacturers to keep pre-1938 drugs on the market by requiring the companies to submit evidence showing, among other things, that the current drugs have the same dosage and labeling as the medications sold before 1938. No drug maker has been able to do that.

Instead of assuming the drug is dangerous, the FDA should be required to make a case that the existing drugs are not safe and/or efficacious. If they are unsafe or ineffective, proving that should be easy to do with 130 years’ worth of experience. This the FDA has not done.

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