Opinion Editorial
August 1, 2002

By Matthew Edgar

“Congress shall make no law…abridging the freedom of speech”- First Amendment to the United States Constitution

Ever since those words were added to the Bill of Rights in 1791, just how much free speech there should be has been hotly contested. One of the many battlefronts for this issue is advertising rights for medical drugs and devices. Pharmaceutical advertising rights are tightly controlled and recently some in the medical community have begun to ask the question “Do these controls violate the First Amendment?”

One regulation that most definitely violates the First Amendment is the off-label drug use regulation. Off-label drug use is all uses for a drug not approved by the Food and Drug Administration (FDA). Correspondingly, on-label use is all uses for a drug that the FDA has approved. Under current drug regulation, drug companies are not allowed to advertise off-label uses of their drugs.

Perhaps the best-known example of off-label drug wars, is the governments interference with the advertisement of Aspirin as a heart attack medicine, (until very recently when this off-label use was approved). Another example is Amoxicillin, which the FDA approved for the treatment of respiratory infections (on-label), but did not approve for the treatment of stomach ulcers (off-label).

By preventing off-label use advertising, the First Amendment rights of drug manufacturers are destroyed, since they can no longer freely determine what to include in their advertisements. Defenders of these laws claim that limiting the approved amount of uses for a drug creates better medical safety. However, medical journals publish research and data on the potential off-label uses of drugs. This information is then used by doctors to help widen the medical choices for their patients. This actually improves the safety of the patient. But doctors who tell patients of off-label uses now have to be careful, because what they say about any drug to a patient might be considered a violation of the FDAs ruling, and therefore not be allowed.

Towards this end, these regulations not only limit drug companies and doctors freedom of speech but actually make the medicine less safe for a patient, first because it limits the amount of drugs on the market (e.g. when Amoxicillin is not advertised as a treatment for stomach ulcers, the stomach ulcers market has one less drug to choose from) and second, because drug companies cannot fully explain the benefits and costs of a drug when they are only allowed to advertise some uses but not others.

Advertising restrictions are not limited to just doctors and drug companies but also to pharmacies in the form of compounded drug regulations. Compounded drugs are defined under the Food and Drug Administration Modernization Act of 1997 (1997 Act) as any condition whereby the pharmacist (or doctor) “combines, mixes, or alters ingredients to create a medication tailored to an individual patients needs”. Compounded drugs are very helpful for patients who have severe allergies to specific parts of drugs and the allergen within the drug can be removed via individual compounding. The FDA not only controls the medical aspects of compounded drugs, but has also restricted the advertising of compounded drugs until earlier this year.

The statute in the 1997 Act that prevents pharmacies from advertising compounded drugs was recently challenged by a group of western pharmacies, including a handful from Colorado, in the Ninth Circuit Court of Appeals. The Ninth Circuit Court of Appeals ruled that advertising limitations on compounded drugs are in violation of the First Amendment. Needless to say, the government lawyers arguing against alleged violations appealed this ruling to the US Supreme Court. The Supreme Court supported the Ninth Circuits ruling of unconstitutionality and was not convinced by the governments argument that this limitation on the First Amendment was necessary to preserve the safety of medicine.

Quite the contrary, if pharmacies are allowed to advertise that they provide individual compounding, patients with severe allergies have a better chance of finding a pharmacy that does individual compounding and thus have a better chance of receiving and benefiting from compounded drugs. Compounded drugs are considerably safer simply because they are more specifically tailored to the individual patient.

This decision by the Supreme Court and the recent challenges to on- and off-label regulations adds further evidence to the argument that allowing doctors, pharmacies, and drug companies more freedom in advertising actually promotes medical safety.

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Copyright 2002, Independence Institute

INDEPENDENCE INSTITUTE is a non-profit, non-partisan Colorado think tank. It is governed by a statewide board of trustees and holds a 501(c)(3) tax exemption from the IRS. Its public policy research focuses on economic growth, education reform, local government effectiveness, and Constitutional rights.

JON CALDARA is President of the Institute.

MATTHEW EDGAR is a Research Associate at the Institute

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