What Does It Mean When a Medication Is FDA Approved?
Understanding the FDA approval process
The Food and Drug Administration (FDA) is a United States governmental agency within the Department of Health and Human Services that helps ensure the safety and integrity of food products, certain drugs, medical devices, vaccinations, and cosmetics. Because of the FDA’s approval process, you can trust the origin, purity, potency, and efficacy of drugs in the US.
However, there are limitations to the FDA’s approval process and their role in medication monitoring. We’ll dive into what the FDA does and what it means when a drug is FDA approved.
An overview of the FDA
The overall mission of the FDA is to protect the health of the American public by guaranteeing the safety, efficacy, and authenticity of certain products manufactured in the US. FDA standards are meant to be universal, well-established, and rooted in experience.
Let’s list out the FDA’s primary roles and responsibilities:
1. Guaranteeing pharmaceutical safety and efficacy
2. Regulating dietary supplements
3. Monitoring medical devices
4. Monitoring vaccinations and biologic products
5. Ensuring the safety of cosmetic products
6. Food labeling and overall safety
7. Regulating tobacco products
8. Monitoring veterinary drugs and animal food
9. Promoting public health
The stages of FDA approval for pharmaceuticals
Pharmaceutical drugs must undergo a specific process to obtain FDA-approval to be sold and distributed in the US. These are the stages and phases each drug must go through:
Preclinical testing
During the preclinical phase of testing, the goal is to assess the basic safety and biological activity for humans or animals. After this phase, the manufacturer can request FDA review for the go-ahead to continue the approval process.
Clinical trials
Clinical trials represent the bulk of the FDA approval process and are conducted in three main phases..
Phase 1
During phase 1, testing of the drug is performed on a small group of healthy individuals. Phase 1 centers upon establishing drug safety and dosage, irrespective of the specific intended action(s) of the drug. This means they aren’t testing the drug to treat a specific health problem; rather, they are testing the drug for general safety and to determine what dose to give.
Phase 2
During phase 2, testing continues on a larger group, this time with people who have the disease the drug is intended to treat. Phase 2 is designed to test the drug's efficacy or, in other words, if the drug accomplishes what it was designed to do. Additionally, during this phase, they will monitor for side effects that are noted in the process.
Phase 3
During phase 3, testing of the drug continues, this time on an even larger group of patients. The goals of this phase include confirming the drug is effective, continued monitoring of side effects, and most importantly, comparing the new drug with more established, frequently used treatments.
After phase 3 is complete, manufacturers can apply for FDA approval and either be approved or denied.
Post-approval monitoring
After a drug is approved, the role of the FDA does not end there. Instead, the FDA continues to use retrospective (“look back”) studies over time periods to ensure the drug remains safe and continues to be effective.
The importance of FDA approval
It is important for patients and healthcare professionals to have a patient-centered discussion of potential risks, benefits, and alternatives of any drug prior to initiating treatment to make an informed decision. So, why is it important that drugs are FDA approved?
Ensuring safety and efficacy
As it is demonstrated through the FDA approval process, the FDA aims to ensure that drugs meet rigorous standards in order to ensure medication safety and efficacy and to protect the health of the public.
Building public trust
The FDA also aims to maintain the public’s confidence in quality and reliability of medications legally and legitimately obtained in the US. Because of the FDA’s persuasive position, the label “FDA-approved” often influences the types of medications providers feel comfortable prescribing and patients feel comfortable taking.
Limitations of FDA approval
Despite the rigorous process the FDA requires for drug approval, it cannot guarantee 100% drug safety. While the FDA processtypically takes years, drugs can still cause longer-term side effects, which may not be known. There are also certain instances when the FDA approval process may be expedited, although clear descriptions are usually provided when that is the case.
The FDA testing and approval process is not only time-consuming (it generally takes 10-15 years to complete the entire process) but is also costly, potentially costing millions of dollars. For more groundbreaking drugs, this length of time might seem less advantageous. Yet, this lengthy, rigorous process helps ensure patient safety.
What does this mean for you?
If you can buy a prescription medication in the US, it has undergone this process. However, if you purchase medications from other countries, their processes likely differ. Also, compounded medications, like compounded semaglutide, do not undergo the FDA approval process. Compounded medications are made in laboratories, some of which are monitored and recognized by the FDA.
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