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Making Drugs Safe and Available without the FDA
Introduction1
The United States Food and Drug Administration (FDA) is the federal agency
charged by law with protecting the public by approving drugs and medical
devices before they are offered for sale in the U.S. Unfortunately, satisfying
the FDA that a new drug is safe and effective delays the introduction of
new drugs for up to 12 years and denies thousands of Americans access to
potentially lifesaving therapies.
The FDA needs reform - manufacturers, consumer groups, academics, Congress
and even the FDA itself realize this. Drug and medical device approval in
the United States simply takes too long.
Some proposed reforms would apply the European system of approving drugs and medical devices to the U.S.: self-certification by manufacturers for medical devices considered to carry little risk, certification by public or private third parties for higher-risk medical devices and independent review committees for drug approval.
While this would be an improvement, we can do better. We can make drug and medical device certification more responsive, both to researchers trying to introduce new lifesaving drugs and to consumers who need them, by abandoning the FDA system and handing drug certification over to private companies. In a free market for drug certification, competition and legal liability would help to ensure that safe drugs are available faster. The FDA would merely set standards and police the market or would be eliminated.
While many Americans favor privatization of other government functions, some are reluctant to privatize health and safety regulation. How do we know the marketplace will work? Because we know it works to ensure the safety and effectiveness of thousands of other products. For more than a century, Underwriters Laboratories, Inc. (UL) and its competitors have protected American consumers from unsafe and ineffective products. The example of UL shows how private agencies might go about certifying drugs and medical devices.