Off Labeling Prescription Drugs

1743 Words7 Pages
“Off- Labeling” Pharmaceutical Drugs When you go to the doctor to receive a prescription, you would expect that the drug prescribed to you is FDA (Food and Drug Administration) approved. Unfortunately this may not always the case and is a common misconception held by the general public. One in five prescriptions in the U.S. are prescribed for a use not approved by the FDA. And most of those (about 75 percent) are for a use that lacks any evidence or rigorous studies to back it up (Consumer Reports Best Buy Drugs 1). This process of a drug being prescribed for a use that wasn’t intended by the FDA is known as “ off- labeling”. Although “off- labeling” prescription medications is legal, continues to grow in popularity, and can seem useful,…show more content…
Off labeling can mean that the drug is used for a different condition than intended for, given in a different way, or given a different dosage than what is written on the drug label. This action is lawful throughout the United States and in several other countries. A rare exception to this legality would be a highly addictive narcotic such as morphine. These drugs cannot be lawfully prescribed unless done by officially approved purposes (American Cancer Society). Once a company’s drug has passed this part of the process by showing that the drug is helpful and safe (Consumer Reports Best Buy Drugs 1), they have to create a drug label. The label must include the following: the name of the drug, critical warnings, dosage information, instructions on how to take the medication, foods and drugs you should avoid while taking the medication, the approved use of the medication, contraindications, the side effects and symptoms of adverse reactions, and instructions on how to store it (Jasper). Once a drug is permitted and can be placed on the market, the company can then go back into the lab and test the drug for other uses. This is important since the companies cannot lawfully endorse a drug to doctors other than what it was approved for (Consumer Reports Best Buy Drugs…show more content…
Companies’ off-label drugs so that they can make a great deal more profit in the end. This is because instead of just selling and having one drug on the market for one sole purpose, they can have one drug on the market that can be used for several other treatments. Although they cannot legally promote the off-label uses of their drugs to the doctors, some companies take the risk anyways for personal benefits. Take Pfizer for example; they had four off-label drugs out on the market that resulted in making their patients sicker and even causing death for the uses that they were prescribed. This cost Pfizer $2.3 billion dollars. If Pfizer hadn’t off-labeled their drugs, a chance of making more of money would not have been presented (Torrey). Another way that the companies profit is by not taking the drug back into the lab to find out new uses for it since they have off-labeling to fall back on. Going back in the laboratory and doing further research costs a great deal of money that doesn’t need to be spent when you can say that the drug can be “used for a different treatment.” The practice of this is not right, playing guessing games with others lives so that you can reap the benefits of their recovery or their
Open Document