[dropcap]H[/dropcap]ave you seen the ad for the new drug that treats runny noses? Taking it will make your nose feel better than ever, BUT, there’s a small chance that you could develop one of the drug’s many side effects: compulsive gambling, blackened urine and death to name just a few. How does such a drug gain approval by the Federal Drug Administration (FDA)? The following will help you to understand this process and the potential risks involved.
A drug’s birth takes place in the laboratory. When a pharmaceutical company finds promising data in a study, they submit an Investigational New Drug application to The Center for Drug Evaluation and Research, a part of the FDA. Should the application be approved, the pharmaceutical company is then able to start testing the drug on HUMAN subjects to determine effectiveness. These experiments are known as CLINICAL TRIALs. If the pharmaceutical company then finds that the clinical trials prove effectiveness, they then submit a New Drug Application to the FDA.
At this point, the FDA will consider the risks vs rewards (benefits) of the new drug. As it would be expected, if the FDA finds that the benefits outweigh the risks, the drug will gain approval. Yet it should be noted that due to the small size of these premarketing clinical trials, the FDA DOES NOT and CANNOT learn everything about the drug’s safety prior to granting it approval. It is thus for this reason, that the FDA continues to monitor the drug even after issuing its approval. This of course makes sense and is done for our safety.
Unfortunately there have been many drugs that gained approval where the risks prove to outweigh any benefits. How could this happen? Perhaps the clinical trials were not well conceived and new or unforeseen side effects occur. Or there could be unclear labeling or even sub-standard manufacturing. Or previously known side effects such as the possibility of a stroke prove to be much higher than previously believed. Worse yet is the case where a drug company actually hides potentially serious side effects.
While no one may be able to take away the pain and suffering that countless patients and their families experience, THERE IS LEGAL HELP, help that can assist with medical and other expenses – all with the aim of improving one’s quality of life.
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