Mandatory FDA approval limits individual choice

The Food and Drug Administration offers a comforting promise of protection, one assuring safety in so many of the products that we eat, use and wear, but its mandated monopoly on merchandise-legality can be responsible for untold deaths as well.

Other than meat and poultry, the FDA’s jurisdiction includes human and animal food products, drugs, cosmetics, and some medical equipment. It boasts an annual budget nearing $2 billion and uses those government funds to investigate potential dangers or adverse results from the products they test.

In theory, that meticulous work allows consumers to buy products without worrying about side-effects and other dangers. However, endorsements from the FDA can certainly be fallible, offering consumers a false sense of safety. Surely the consuming public is able to make its own decisions.

Historically, mistakes have been made that, if nothing else, at least lessen the credibility of an FDA approval. There is no better example than that of fenfluramine and dexfenfluramine, drugs commonly known as Fen-Phen. In 1997, after doctors found that nearly a third of tested patients using the drugs to combat obesity had abnormal echocardiograms.

That means one in three people who used the Fen-Phen drugs had enlargements, disease, or other problems with the function of his heart. There was a major recall, resulting in innumerable law suits and huge settlements, not to mention punitive health problems of which the severity is still in question. No small misstep.

Further, callbacks or withdraws of products under the FDA’s jurisdiction happen more than some might realize. This month, many large national papers, including The New York Times and USA Today, reported that Merck withdrew its arthritis and pain medication Vioxx.

This came after a study showed that the chances of heart attacks increased for users of the drug. The stories had more of a business tone, (Merck’s fiscal woes) than a health issue (ambiguous study results) because Merck pulled the drug before federal regulators intervened.

But if FDA approvals cannot ensure complete well-being, isn’t that more reason for consumers to be given the ability to choose any product, whether the FDA endorses it or not? The constant argument is that the FDA’s purpose is to protect the consumer and that mistakes are absolutely inevitable. Yet, think of being in a situation in which you were diagnosed with a seemingly incurable, certainly fatal disease. After exhausting all traditional and FDA approved treatments, you hear of an experimental method that has the possibility to save your very uncertain life.

Left without any option, death looming, wouldn’t we all at least appreciate the choice to use that method, however chancy it may be? Sadly, that isn’t an option because big government doesn’t trust us with our own lives.

Obviously, the FDA offers years of research that the average consumer cannot do alone. But why not continue the FDA’s work while also allowing products to be sold or used without the FDA’s approval?

Consumers could then make the choice to wait for the FDA’s support, or have the option to take a chance on his or her own.

The most real and poignant argument for stopping the mandatory nature of FDA approval came from a one-hour ABC News special called Sex, Drugs, and Consenting Adults, hosted by correspondent and famed Libertarian John Stossel.

His travels and research found the story of a terminally ill girl whose hopes to try an experimental medical treatment as a last chance of survival were denied because the FDA felt that the treatment was too dangerous.

Apparently, the risk of becoming sicker outweighed her inevitable death. Government should not have the right to send a child to certain death without all options being exercised. The choices for our lives should be ours to make.

Christopher George Wink can be reached at

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