How drugs are deemed harmful
Prescription medications and drugs in general can be extremely helpful in treating injuries and ailments, but they can also cause a lot of harm. Unfortunately, drugs are oftentimes misused or prescribed by doctors for something they were not intended to treat. When this happens, it can lead to devastating side effects, and even death. As we know, medical malpractice is one of the top (3rd, actually) leading causes of death in the United States. In many cases, medical malpractice occurs when a drug has been misprescribed.
In addition to problems with how drugs are prescribed, there are also a lot of issues surrounding how they are manufactured. Both drugmakers and medical device manufacturers have a responsibility to make sure all the products they are developing and selling are safe to use. Even though this is the case, every single year manufacturers release drugs that are harmful and dangerous to consumers. Because of this act of negligence, hundreds of thousands of people have been harmed or suffered wrongdoing.
The FDA and Dangerous Drugs
The Food and Drug Administration (FDA) is in charge of determining how safe or effective drugs and other products are. They have a strict action plan that governs how they regulate drugs and how they determine which drugs are dangerous and should not be marketed to consumers. This is a somewhat complicated process, but there are a few important steps worth mentioning in order to give you a better idea of what a drug must go through in order to get approved:
- All new drugs must undergo laboratory or animal tests in order to see how it works and whether or not it will be safe enough to be tested on humans
- If it passes this phase, a series of clinical trials on humans are conducted
- The drug’s manufacturer then sends its data from these tests to FDA’s Center for Drug Evaluation and Research (CDER). At this point a team of physicians, toxicologists, pharmacologists, chemists, and other scientists review the data
- If the drug is deemed safe after it is reviewed by this team, it is approved to be marketed
- The FDA monitors the drug once it hits the market, making sure there are no reported adverse reactions or other issues
- In the event a problem or negative side effect is discovered, the FDA may issue a Drug Safety Communication to consumers and health professionals
Unfortunately, there is no standardized way of tracking the adverse effects of a drug or other medication. This is due to numerous factors, but namely because our healthcare system is not integrated. Consumers report negative side effects of drugs to MedWatch on a regular basis, but because this system is voluntary, not all adverse reactions are reported. The FDA is tasked with conducting the clinical trials mentioned above and determining whether or not the pros outweigh the cons when it comes to the safety of drugs. This is not a foolproof system, meaning numerous drugs slip through and are approved, even though they are potentially dangerous to consumers.
When it is discovered that the risks of a drug outweigh the benefits, it is then removed from the market. In most instances, drugs are taken off the market because of safety issues that cannot be reversed. When the FDA makes this decision, they notify the manufacturer that is should no longer be marketed or manufactured. In most cases, the manufacturer of the drug voluntarily stops production. However, if they continue to manufacture and market the drug, leading to consumers experiencing serious side effects, they may be held liable.
Dangerous drugs are a very serious, growing problem in the United States that should not be taken lightly. If you or a loved one has experienced negative side effects after taking a specific medication, please contact AMA Law today.