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Court Strikes Down the FDA's Speech Regulations

They say that knowledge is power, that knowing is half the battle; and the explosion of knowledge that has emerged in the information age has undoubtedly made the world and its citizens far, far richer. Knowledge saves lives and elevates people from rags to riches. You would think that government would then be interested in promoting the spread of knowledge to as many people as possible, to maximize well-being among its citizens. You would think wrong.

The Food and Drug Administration (FDA) exercises strict controls over what information drug companies are allowed to publicize, and in many cases, these limitations result in needless deaths.

This was the issue in a recent court case in which a New York district judge ruled that some of these limitations violate the right to freedom of speech. The restrictions in question limit what is known as “off label marketing.” What this means is that a drug company can only market its products for uses approved by the FDA, even if it turns out that the drugs have other benefits as well.

For example, suppose a company had gone through the rigorous approval process to get the FDA to sign off on a new drug for, let’s say, insomnia. The FDA agrees that the pill helps people sleep, and allows the company to market it for that purpose. Suppose then that further research emerges showing that the sleeping pill can shrink cancerous tumors as well. Current law forbids drug companies from publicizing this information to consumers, to doctors, or to anyone else who might find it useful. Cancer treatment is an “off label” use for the drug, and therefore forbidden.

The problem with these laws is obvious. There may exist many effective treatments for life threatening diseases, but we would have no way of knowing it, since that fact is not allowed to be advertised. It’s impossible to estimate the number of needless deaths resulting from such suppression of knowledge, but it is sure to be significant.

The court’s decision is an important victory, not only for our constitutional rights, but also as a first step in removing some of the regulatory barriers that are making health care less available and more expensive. The FDA’s regulations have consistently held back innovation and kept prices higher than they need to be. If we really care about improving health care in America, permitting more freedom in the market would be a good place to start.