The Food and Drug Administration (or FDA) is now considering running advertisements on television for drugs they haven’t even approved yet. They feel allowing this should be a form of “protected” free speech.

This may not mean that the drugs themselves are safe, but they may advertise them as a remedy for certain conditions that they haven’t yet been tested on. Evidently, doctors are allowed to prescribe medication that hasn’t been approved to treat certain conditions in what is known as “off-label.” Although this seems like bizarre practice, it is actually fully legal and not that uncommon.

In fact, currently, one in five drugs prescribed to people are for off-label use, meaning that they are used for something other than the drug was originally intended for.

There are several larger and common examples of this. For instance, anti-malarials, like Plaquenil, were clearly invented to reduce one’s chance of developing malaria in a country where the disease is prominent. However, researchers have found that it also treats disorders like lupus and other autoimmune diseases.

Another popular example is amitriptyline. Although originally manufactured as an anti-depressant, many doctors now prescribe it for pain conditions. This is partially because it works and partially because it is less expensive than many other medications that manage pain in the same way.

However, advertising these secondary benefits, or “off-labels” has been illegal since 1962. This is due to a case in which a drug intended for something different was touted as a cure for morning sickness. As a result, many women gave birth to babies with defects, which has lead to a total ban of this practice.

Lisa McGiffert, director of Consumer Reports’ Safe Patient Project states of the proposal:

“Relaxing the current rules would dismantle a legal firewall that has protected Americans from false and misleading drug advertising for more than half a century. The consequences could prove deadly.”

In a survey of the general public, 84% of people have stated that they do not want unregulated drugs advertised on television or in print.

But in some cases, however, illegal advertising has still taken place. It is important that you are proactive and ask your doctor questions about your medication before you take it.


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