Before a drug can be released on the market, it must go through a strict approval process with the United States Food and Drug Administration (FDA). The FDA regulates the various steps that prescription drugs and other items must go through before they can be marketed to the consumer. Not many people are aware of the approval process or the way in which the FDA regulates prescription drugs. Here’s how it works.
The Beginning of the Process
The manufacturer of the drug must perform their own internal safety testing in a lab or on animals to understand the way the drug works and any early adverse reactions humans may experience. They will then submit an Investigational New Drug Application (IND) before they can begin testing on humans. The manufacturer will then conduct a series of clinical trials on humans. There are three phases in which the effectiveness and safety of the drug is assessed, and the FDA monitors these tests. The drug is then developed and that test data is sent to the respective FDA groups who will establish the benefits vs. the risks.
Entering the Market
After the review process has been completed and the FDA has made a decision regarding the safety of the drug, it may either be sent back for further development or testing or approved for sale. Even after it has been approved, the FDA will still monitor the performance of the drug to make sure any new adverse events will be reported.
If new adverse events are reported, the FDA can take additional actions to require the drug’s labeling to contain specific warnings. They can also recall a drug from the market if it proves a danger to consumers.
Black Box Warning
The FDA may order a pharmaceutical company to include a black box warning on a product that clearly warns of the product’s potential dangers. This information can help doctors and patients make an informed decision about whether the benefits of the drug outweigh the risks for treating a particular condition. It is important to make sure you pay close attention to these types of warnings as a consumer to avoid potential harm.
If someone is harmed due to a dangerous drug, they may have the right to take legal action to hold the manufacturer accountable for the damages. The pharmaceutical company may be financially responsible for paying damages associated with the injury such as hospital bills, lost wages, pain and suffering, and more. The St. Louis dangerous drug lawyers at The Simon Law Firm, P.C. have the experience to help injury victims seek justice when they have been wronged by a drug company. Our team stands ready to help.
Ready to discuss your potential case? Call us today at (314) 241-2929.