You may have often come across the term that a drug is FDA-approved. But what exactly does this mean and how does a drug actually reach the market? Well, to start with the Food and Drugs Administration (FDA) is the federal agency in the US that controls drug regulations.
All prescription medications have to be approved by the FDA before it is sold to customers. This process is rigorous and it can take many years before a particular product reaches the market, unless the drug is a breakthrough one that can treat major illnesses like cancer and HIV. The review process is sped up for such medications. Over-the-counter medications also go through the rigorous review process though it may be less stringent, especially if the drug is deemed to be safe. Generic variants of brand name drugs too come under the FDA’s review and approval process, though this is less rigorous and the drug company primarily has to prove just the bioequivalence.
Vitamins and herbal supplements do not come under FDA review, though some of the companies falsely say they are FDA-approved for marketing purposes.
What are the processes involved in getting a new drug approved by the FDA?
The entire process of getting a new drug approved by the FDA would take on average at least 12 years. The amount that drug companies invest to get a new drug to the market is also tremendous. The following are the steps involved in getting FDA approval for a new drug to reach the market.
- All medications start at the stage of pre-clinical research.
- Once there is sufficient data to suggest that a drug can be investigated further, an application is submitted with the FDA to commence human trials. Only a fraction of the thousands of applications pass the review and receive the green light to continue with the research and test the medication in human trials.
- Next, the drug evaluation undergoes three phases of clinical trials. In the first, the medication is studied for safety in a group of healthy volunteers. The second phase involves checking the efficacy of the medication in larger patient groups. The third phase involves clinical trials in hospitals to see the effectiveness and also study adverse reactions.
- Once the drug crosses these phases and sufficient data is available to show that the medication is suitable for use, the drug company submits a New Drug Application (NDA) with the FDA.
- The NDA review can take a year to much longer before the FDA approves the medication for sale.
This entire process can take many years but this is how important medications are made available to the public. All medications are FDA-approved even though marketing campaigns may focus on this aspect. This makes the medication relatively safe to use. Prescription medications should at all times be taken only after consulting with the healthcare provider and getting the suitable dosage. The FDA actively ensures that all drugs available in the market are safe to use.