Is the FDA necessary?

     How often do you get sick in a year?  We all keep tabs.  Then, you can estimate which medications you should stock up on for the seasons approaching.  Throughout those steps, we don't question the efficacy rate of those medications.  Sticky note on the refrigerator reads, "Will this Ibuprofen work on a headache?"  In the U.S., we don't worry about this because we have the FDA.

     The U.S. Food and Drug Administration (FDA) is a government agency responsible for ensuring that drugs, medical devices, and other products intended for human and animal use are safe and effective. (www.fda.gov) The FDA uses a rigorous process to evaluate the safety and efficacy of drugs before they can be sold in the United States. This process involves extensive animal testing and human clinical trials to assess the drug's impact on the condition it is intended to treat, as well as any potential side effects.

          "Before a generic drug can be marketed, FDA must approve the generic drug application. According to FDA, applications go through an average of three cycles of review before being approved, which may take years."

     Once a drug is approved, the FDA continues to monitor its safety and effectiveness through post-marketing surveillance. This includes analyzing reports of adverse events and taking action if necessary to protect the public from harm. Health care providers and patients can report adverse events associated with drugs through the FDA's MedWatch program, which is an important tool for identifying safety concerns and taking appropriate action.To ensure drug safety, it is important for patients to purchase medications only from licensed pharmacies located in the United States. This helps to ensure that the drugs they are taking are genuine and have been manufactured and stored under appropriate conditions. Patients should also make sure they understand how to take their medications correctly, including any potential side effects or interactions with other drugs or foods. By taking these steps, patients can help to ensure that they are getting safe and effective medications that will help them to manage their health conditions.

     The FDA is necessary. The FDA plays a critical role in protecting the public health by ensuring that drugs, medical devices, and other products intended for human and animal use are safe and effective. Without the FDA, there would be no reliable mechanism for ensuring that the products we use to maintain our health and well-being are safe and effective.An example of the FDA's importance can be seen in the recent approval of COVID-19 vaccines. The FDA played a key role in the development and approval of the Pfizer-BioNTech, Moderna, and Johnson & Johnson COVID-19 vaccines, which have been shown to be safe and effective in clinical trials involving tens of thousands of people.  (www.cdc.gov) The FDA carefully reviewed the data from these trials to ensure that the vaccines were safe and effective before granting emergency use authorization. The agency continues to monitor the safety and effectiveness of these vaccines as they are rolled out to the public. The rapid development and approval of these vaccines would not have been possible without the FDA's expertise and regulatory oversight.


     The FDA (Food and Drug Administration) was established in 1906, with the passage of the Pure Food and Drugs Act, which was the first law to regulate food and drug safety in the United States.Similar organizations to the FDA exist in other countries as well. For example, in Canada, there is Health Canada, which is responsible for regulating food, drugs, medical devices, and other products intended for human use. In the European Union, there is the European Medicines Agency (EMA), which is responsible for evaluating and supervising the safety and efficacy of medicines before they can be marketed in the EU. In Japan, there is the Pharmaceuticals and Medical Devices Agency (PMDA), which is responsible for ensuring the safety and efficacy of drugs and medical devices.Most countries have a regulatory agency or agencies responsible for ensuring the safety and efficacy of drugs, medical devices, and other products intended for human use. These agencies play a critical role in protecting public health by ensuring that the products we use are safe and effective.