The U.S. Food and Drug Administration (FDA) is charged with regulating the safety, efficacy and quality of drugs that are manufactured and distributed in the United States. It is a powerful force in the world of drug regulation. The FDA is responsible for approving new drugs, ensuring that drugs are safe and effective, and that they are properly labeled.
The FDA is also responsible for overseeing the safety of the drug supply. In addition, the FDA has an obligation to ensure that all drug companies are complying with all legal requirements and regulations.
The FDA has a complex and important role in ensuring that drugs are safe for consumers and for the general public, but it is important to remember that FDA approval is not the same as being safe or effective. The FDA approves drugs based on standards set by law, but not every medication approved by the FDA are safe or effective.
FDA Regulation and Drug Safety
The FDA has several responsibilities when it comes to ensuring that drugs being used in the United States are safe and effective. These include:
- Marketing approval review panel meetings. The FDA conducts meetings with representatives from different drug review panels to discuss concerns about a particular drug. The drug review panels consider the scientific evidence submitted by the drug manufacturer and decide whether the drug should be approved or not. Generally, a drug will be approved if they find it is safe and effective.
- Labeling requirements. The FDA requires that all new drugs be properly labeled. This includes providing adequate directions for use as well as cautionary information about potential side effects.
- Warning letters. If the FDA discovers that a drug is unsafe or ineffective, it may issue a warning letter to the manufacturer or distributor of the product. Warnings are intended to give manufacturers or distributors an opportunity to correct any problems that have been identified by the FDA before more serious action is taken against them by the agency.
The Complications Of FDA Oversight
The FDA has an important role in ensuring that all drugs are safe and effective for consumers, but this does not mean that all drugs approved by the FDA are safe or effective. In fact, some of the drugs approved by the FDA have been found to have serious side effects or even be unsafe for consumers to use at all levels of consumption.
Some of these problems have been discovered after large numbers of people have suffered from serious side effects from using certain drugs because they were not properly tested before being approved by the FDA for use in the United States. These include:
- Drug side effects. Some drug side effects are very rare and may go unnoticed for years before someone reports them after using a particular drug for some time. When these side effects are discovered, they may not be reported to the FDA until many years after they first occurred because they were not recognized as symptoms associated with that drug until much later.
In January 2020, the US Food and Drug Administration (FDA) approved the drug teprotumumab (brand name Tepezza) as a treatment for thyroid eye disease (TED). The drug was approved as a result of two clinical trials that showed promising results in improving the symptoms of TED, such as bulging eyes and double vision.
Unfortunately, since its approval, a number of patients who have taken Tepezza have reported serious side effects, including heart attack, stroke, and severe hearing loss. In some cases, these side effects have been so severe that they have led to death. In response, numerous personal injury lawsuits have been filed against the manufacturer of Tepezza, Horizon Therapeutics, alleging that they failed to properly warn patients of the potential risks of taking the drug.
The lawsuits allege that Horizon Therapeutics was aware of the potential risks associated with Tepezza, but failed to disclose them to patients. In response, Horizon Therapeutics has defended its actions, arguing that the potential risks of taking Tepezza were outlined in the drug’s labeling and that it was up to physicians to inform patients of these risks.
It remains to be seen how these personal injury lawsuits will play out, but it is clear that the FDA’s approval of Tepezza has been a source of controversy and has resulted in a number of medical problems for those who have taken the drug.
- Drug recalls. Some products have been recalled because they contained contaminated products from other manufacturers or were contaminated by other companies who were attempting to pass off their products as being made by other companies who were actually responsible for producing them. As a result of this type of contamination, people have suffered serious side effects from using products that they thought were safe or effective when they were actually contaminated with dangerous chemicals or bacteria that caused people to suffer serious illnesses and even death as a result of using them long before anyone became aware that they were contaminated.
The FDA is responsible for approving drugs that are safe and effective for consumers, but this does not mean that all drugs approved by the FDA are safe or effective. In fact, some of the drugs approved by the FDA have been found to have serious side effects or even be unsafe for consumers to use at all levels of consumption.
Talk with medical professionals until you have a full understanding of the risks and benefits of any drug before you take it.