By: Vivek J
January 13 2022
The FDA follows a strict approval process and evaluates all clinical data related to a drug's safety and efficacy before approving it for public use.
A recent post on Facebook accused the U.S. federal agency of approving drugs without following the scientific process. Even though the post does not mention COVID-19 vaccines directly, many of the comments under this post claimed that COVID-19 vaccines were approved by the FDA without clinically evaluating their safety. The claims circulating on social media are baseless and not backed by any evidence. The U.S. Food and Drug Administration (FDA) is the agency that oversees the labeling process of medications and supplements. DIfferent approval processes are followed for prescription drugs and over-the-counter drugs. However, in both of these cases, a stringent evaluation method is followed to ensure the safety and efficacy of these drugs. According to FDA regulations, a company seeking to approve its drug must follow a five-step process: discovery, preclinical research, clinical research, FDA review, and FDA post-marketing safety monitoring. For a drug to be approved by FDA, the Center for Drug Evaluation and Research (CDER) reviews its safety and efficacy data. The FDA does not conduct the pre-clinical nor clinical studies itself, but it does inspect the labs where the studies are carried out, in addition to evaluating those studies. Furthermore, the drug's benefits to the potential risks for the intended population are extensively studied. After acquiring clinical data, the drugs are approved only after the product satisfies the necessary conditions required by the approval process's structural framework. All drug manufacturers must meet all the required parameters put forward by FDA to make their product available to the public. There is no evidence showing that the FDA has violated its approval policies in approving COVID-19 vaccines for emergency use. Pharmaceutical companies are required to continue monitoring their drugs after they're FDA-approved and released on the market. If further safety concerns arise, they report these concerns to the FDA, and the FDA can issue a recall. However, there have been no such safety concerns for the COVID-19 vaccines.