Recently, news outlets confirmed the Pfizer Covid-19 vaccine had received a full FDA approval. As the first and only Covid-19 vaccine to receive this stamp of government approval, this has left consumers wondering how exactly the Food & Drug Administration (FDA) approval process works. Although it originally went by a different name, the organization now known as the FDA began in 1906. While the phrase “FDA approved” is commonly used, many do not know what it actually means. Learn more below about how products earn an FDA approval.
What is the FDA?
The FDA, or officially known as the Food & Drug Administration, is in charge of protecting the public by ensuring the efficacy and safety of a variety of items such as medical devices, veterinary drugs, food, and biological products. They are also responsible for reducing the use of tobacco products by minors and regulating the manufacturing and distribution of tobacco products in general.
What is the Process for FDA Approval?
For most drugs, it takes around 10 years from discovery to final FDA approval. This may seem like an extremely long time, but it’s a tried and true way of ensuring the safest drugs make it to the market. The first phase of the FDA approval process is discovery and development. During this phase, studies are conducted on testing molecular compounds, figuring out appropriate dose amounts, side effects, drug interactions, and other ways the drug interacts with the body.
The second phase is preclinical research, which tests the drug in two different environments – in a controlled environment outside of a living organism and inside a living organism. This is done in smaller studies than clinical trials and if it is determined to be safe to test in humans, it will proceed to the third stage.
The third phase is clinical research, in which the drug will be tested on humans to examine how the drug interacts with the body. This phase includes 4 sub-phases, which varies on the amount of volunteers and time ranges.
The fourth phase is FDA review, in which the pharmaceutical company completes an application to allow for marketing of the drug. In many cases, there may be additional research needed or issues that need to be resolved before approval. If the FDA review team approves the application, they will work with the pharmaceutical company to finalize details, including prescribing information.
The fifth and final phase is the post-market safety monitoring done by the FDA. During this phase, the FDA will monitor the marketing and the manufacturing facility to ensure that it’s all in compliance with the FDA requirements. According to a Jersey City personal injury lawyer from Brady, Brady & Reilly, LLC, who specializes in product liability, “When a consumer’s product…causes a serious or fatal injury, the law imposes a strict liability on those who designed, manufactured or distributed it.” This phase is essential for not only protecting the consumer, but protect the manufacturer as well.
As a consumer, we place a lot of trust in the companies who manufacture our medicine, food, and veterinary drugs. An FDA approval is an added level of protection and trust that can help make consumers more comfortable with what they are buying and ingesting. To learn more about the FDA, visit the official FDA site.