Freedom from the FDA
By Richard E. Ralston
It took the Food and Drug Administration more than a century to grow into a massive, expensive, wasteful, inflexible, ineffective, distant and indifferent bureaucracy. It now violates a founding principle of the practice of medicine: "First, do no harm."
The FDA does a lot of harm, every day. Why do we allow that?
The FDA has kept some unsafe or ineffective drugs off the market (although a consortium of independent research organizations could have done the same thing). But at what cost? We can summarize in ten ways how the FDA threatens or does real harm to our health:
The FDA adds billions of dollars to the cost of developing new drugs and delays their use for years. Yet it is so obsessed with predicting exactly how each drug will perform for any patient—with any condition, in any dosage, for any length of time and in any combination with any other drug or combination of drugs in any dosage—that it often loses sight of safety. So a few years ago the FDA proposed the creation of a new "Drug Safety Board" to provide for drug safety. One would have thought that was the purpose of the whole agency.
That hypocrisy is consistent with the history of the agency. Every failure to fulfill its purpose is met with a review or a study by another government-related organization hired by the FDA to make recommendations. The recommendations are always the same: more staff, more budget, more authority, more buildings, more office furniture and more regulations.
If we want the tremendous progress in the development of medications in recent years to continue, we must act to eliminate the awesome ability of the FDA to destroy that progress. The first steps in reform should be to direct the FDA to focus entirely on safety and allow physicians and their patients to determine efficacy. Research must be encouraged, not restricted, and information on that research must be open to all.Richard E. Ralston is Executive Director of Americans for Free Choice in Medicine, Newport Beach, California. Copyright © 2008 Americans for Free Choice in Medicine. All rights reserved.