How the FDA Approves New Drugs

Instructor: Rachel Torrens
In this lesson, you'll meet Nancy the Nose Spray and learn about the long journey she must take - from her birth to her early years as a fledgling prescription drug, and finally to a seasoned, over-the-counter medication.

Prescription Medications Provide Relief

It's spring. The sun is shining, flowers are blooming, and you can't stop sneezing. All day long clear snot is running from both of your nostrils and your eyes are itching. Finally, you decide you cannot handle it anymore, so you go to your healthcare provider, Dr. Sneeze.

Dr. Sneeze diagnoses you with seasonal allergies and prescribes a medication. You take the prescription to the pharmacy, and then you meet someone who changes your life. Her name is Nancy, and she is a nose spray. After two days, Nancy the Nose Spray alleviates your symptoms. No more runny nose, no itchy eyes, no sneezing. You are able to enjoy spring, thanks to Nancy!

So how did Nancy come to be in the first place? Let's look at the process she went through to get to your nose.

Prescription Versus Over-The-Counter Medications

In the world of medicines, there are two broad categories into which all drugs, including Nancy the Nose Spray, are placed: over-the-counter (OTC) or prescription.

Over-the-counter medications can be obtained directly from a store without a prescription.
Over the counter medications available for purchase from a store shelf.

These two types of medications differ in several ways. First, OTC medications are generally milder. Why? Because they are for the everyday person who diagnoses him or herself independently of medical help, then selects a product to treat the symptoms. OTC drugs can be most commonly found on the shelves of grocery stores, pharmacies, or large chain stores.

These are prescription medications, only available by having a prescription filled at a pharmacy.
Prescription medications filled from a pharmacy.

Prescription medications are stronger because a healthcare provider diagnoses the illness and writes a prescription for the appropriate medicine. Then, you take this prescription to a pharmacy to be filled. If you recall, Nancy the Nose Spray was a prescription medication provided by your healthcare provider, Dr. Sneeze. How did she become one? Let's see!

New Drug Application Process (NDA)

Since 1938, the New Drug Application (NDA) process has been in place, helping to ensure that medications are safe to consume.

The NDA tells a specific drug's entire life story. It details the creation of the drug. Also, it proposes a use for the drug, highlighting its benefits but also outlining its risks. The NDA tells of the intended manufacturing methods and labeling of the drug. Lastly, it specifies the proposed drug insert (that folded piece of white paper covered in size 10 font that most people throw right in the trash).

This application is then submitted to the Food and Drug Administration. After making its way through several departments and a thorough review process by healthcare providers and scientists, if the drug is considered safe and effective and has appropriate labeling, it is approved for marketing in the United States.

And this is the process through which Nancy the Nose Spray had to go in order to reach you. Nancy's NDA is like her biography, describing the place of her birth, her achievements and her faults. It tells her story, which the FDA reads. If the FDA deems her story ready, then Nancy is marketed for use as a prescription.

Switching From Prescription To Over-The-Counter

Once a prescription medication comes to market, the manufacturer begins tracking its efficacy and safety. As more individuals use a prescription, the data grows. Once it is established that a medication is both safe and effective for the general public, the manufacturer can attempt to have it changed to an over-the-counter product. To do this, the manufacturer must submit the data, known as an efficacy supplement, with the original New Drug Application to the FDA for approval. Now, this is only true if the medication is going to be exactly the same. If the manufacturer wishes to make a change, then the drug must start the NDA process from the beginning.

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