When your child is sick and needs medicine, it's important that the drug is safe and works well. The U.S. Food and Drug Administration (FDA) makes sure of that. Before any new medicine can be sold, the FDA carefully checks it to protect your health. Here's the FDA's approval process for new drugs. safe.
What does it mean for a product to be "FDA-approved?"
The U.S. Food and Drug Administration (FDA) examines, tests, and approves a wide range of items for medical use, including drugs, medical devices, food, cosmetics and many other health-related products. In the simplest terms, "FDA approval" means that the FDA has decided the benefits of the approved item outweigh its potential risks.
Before the FDA, companies could make claims about a product, without proof that it was safe or that it even worked. This made consumers extremely vulnerable. Now, new products must go through the FDA approval process before they are available to the public.
Why is the FDA approval process important?
FDA approval is important, because it validates the need for research on how drugs work on children, not just adults. It also allows us to properly determine the appropriate dosage for children, determine the best route of administration, and test for any drug interactions.
How does a drug or device get FDA approval?
In order to receive FDA approval for a drug or a medical device, the manufacturer must prove to the FDA that the item is "safe and effective." Although no drug or medical device is entirely risk-free, the research and testing must show that the benefits of the drug or device for a particular condition outweigh the risks to patients of using the item.
Here's a brief overview of the steps involved in a drug becoming FDA-approved:
Drug developed: A company develops a new drug and seeks to have it approved by the FDA for sale in the United States.
Animal testing: Before testing the drug on people, the company must test the new drug on animals to find out whether it has the potential to cause serious harm (i.e. toxicity).
IND application: The company submits an Investigational New Drug (IND) application to the FDA based on the results from the initial animal testing. These results must include the drug's composition and manufacturing and the proposed plan for testing the drug on people.
Clinical trials: After the FDA reviews and approves the IND application,
clinical trials to test the drug on people can begin. There are 4 phases of clinical trials, starting with small-scale trials, followed by large-scale trials. After the clinical trials, the researchers then submit study reports to the FDA.
NDA application: Once a drug developer provides evidence that the drug is safe and effective, the company can file a
New drug application (NDA): The FDA reviews the application and makes a decision to approve or not approve the drug.
Drug labeling: The FDA reviews the drug's labeling/packaging and makes sure appropriate information is communicated to health care professionals and consumers.
Facility inspection: The FDA inspects the facilities where the drug will be manufactured.
Drug approval: The FDA approves the NDA or issues a response letter.
Post-marketing monitoring: Once the FDA approves the drug, the company is required to submit periodic safety updates to the FDA.
What is the difference between "FDA Approval" and "Emergency Use Authorization?"
"Emergency Use Authorization" or EUA was used during COVID-19 to rapidly bring to market novel therapies and vaccines for COVID-19. Several features make this process distinct from typical FDA approval:
HHS authorization: EUA can only be employed if the Secretary of HHS, Homeland Security, or Defense determines that there is a real or potential threat to national health or national security caused by, in this case, a novel virus
Emergency: Allows FDA to permit use of otherwise unapproved medical products, or unapproved uses of approved medical products during an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions
No alternatives: Can only happen if there are no adequate, approved, or available alternatives
Balance of risks/benefits: Known and potential benefits must outweigh the risks, and manufacturers typically submit as much safety and efficacy data as possible when requesting EUA
Importantly, once the emergency that prompted the EUA has been resolved, such therapies need to undergo the typical FDA approval process to continue being marketed. For instance, hydroxychloroquine was initially authorized under EUA for the treatment of COVID; however, this was withdrawn when the benefits did not outweigh the risks. In contrast, the medication remdesivir was initially authorized under EUA for treatment of COVID, and was subsequently approved through the usual approval process as an approved agent for treatment of COVID.
Do over-the-counter drugs and medical devices need FDA approval?
Yes. Drugs sold
over-the-counter (without a prescription) must be approved by the FDA. For instance, over-the-counter pain medications must be FDA-approved to treat pain. Their labelling is also approved by FDA
What is considered when rescheduling a drug?
The Controlled Substances Act (CSA), part of the Comprehensive Drug Abuse Prevention and Control Act of 1970, is the legal cornerstone of the government's war against drug abuse. The U.S. Drug Enforcement Administration (DEA) has divided these substances into five categories, called "schedules," based on each drug's (1) potential for abuse, (2) safety, (3) addictive potential and (4) whether or not it has any legitimate medical applications. Schedule I is reserved for drugs considered to have the highest
potential for abuse and no current accepted medical use. Rescheduling
marijuana, for example, would not make it legal but reclassifying the schedule could potentially increase research being done on the drug.
Click here to learn more about the FDA's drug approval process and marijuana.
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