Unlicensed and unapproved drugs, these phrases might create a terrifying image.
You may imagine some seedy, under the table alternative to a vaccine. Possibly an outdated and dangerous medicine that has no place in modern society.
The world’s first vaccine may even come to mind. Pus from a cowpox boil was used to prevent smallpox in a practice that would cause nightmares today.
Actually, while the phrases are accurate, unlicensed and unapproved drugs don’t have to mean the medicine or vaccine is dangerous.
Before hitting the market, a new drug often relies on approval from the Food and Drug Administration. This process costs money in tests and studies, and can take years or even decades to complete.
In giving its approval to the drug, the FDA is ensuring safety and effectiveness compared to similar medicines.
Whether it’s prescription drugs or an over-the-counter medication, many want FDA approval before using the product.
But, companies can still put their drugs on the market without a thumbs up from the FDA.
Manufacturers may choose to rush to the market because the approval process costs too much or the drug is needed immediately.
Just because a drug is missing the approval doesn’t guarantee it’s unsafe.
Foreign drugs are often sold without FDA approval. Testing and studies are done in the country of origin and companies don’t have time to go through the FDA’s process in the United States. This doesn’t mean the foreign drugs are unsafe, just that they haven’t passed the U.S.’s standards.
The greatest caveat in selling unapproved drugs comes in the marketing.
It’s easy to sell a product that can proudly boast approval from the FDA. The FDA’s label is often given its own section of the directions and helpful information leaflet.
But, these unlicensed drugs offer no such stamp from the FDA. Whether in a commercial, in an advertisement or on a label, the manufacturers can in no way claim they earned the administration’s support.
When a company breaks these rules, the FDA reserves the right to take legal action. This often ends with the product immediately pulled from shelves and a hefty fine for the company.
The phrase “unlicensed drugs” isn’t only reserved for medicine without FDA approval.
The alternative is drugs that are used in ways or for reasons not intended on the label.
These kinds of uses can offer much more risk. Whether prescribed by a doctor or chosen by themselves, a person will overdose, mix with different drugs or use it to treat a different illness.
Every medicine comes with side effects. These are often small consequences that are more of an annoyance than any danger. These are the side effects that are tested by the FDA. After reviewing the years of studies and research, the administration deems that those are the usual reactions to a drug.
But, when using these off-label drugs, the consequences are completely unregulated.
The risks probably don’t seem to outweigh the benefits. But, doctors are sometimes put in a corner where off-label use of a drug is the only option. If medicine or a vaccine isn’t available to treat one illness, they may prescribe a drug that’s meant for something else.
This happens with drug shortages or with the discovery of new diseases that don’t have a treatment. Doctors know the chance of dangerous outcome, but they just may not have any other choice at that moment.
Until there’s an unlimited supply of medicine to treat every disease in the world, unlicensed drugs will be a reluctant need in the medical community.