The first thing you will find on the internet when you search for a remedy to disease is countless prescription drugs promising a lot of potential abilities. The drugs and their names that you see splashed across your computer or mobile screens all make the promise of helping you recover from the issue. But how will you trust these drugs?
Making a choice would be difficult for a consumer especially when we know that prescription drugs have a lot of side effects too. However, the situation is not extremely dismal because the U.S. Food and Drug Administration helps you make an informed decision. To learn more about how a company can get its drug pass through the FDA’s drug review process smoothly, you may contact a Life Sciences Consulting Service.
Is the FDA drug approval process controversial?
As far as criticism is concerned, yes the FDA has come under immense criticism. One of the reasons why the FDA comes under fire is that the manufacturers can get a drug approved after establishing that their drug is similar to one that was already available in the market.
Another point that consumers don’t realize is that the FDA weighs both the benefits and potential risks of a drug before approving it. So if the benefits are outweighing the risks then the FDA will approve it. Hence, much of the criticism is unjustified. The broader interest of the patient is kept in mind before making a decision. You simply cannot view the situation in black and white.
The different stages of the drug approval process
Coming back to the topic of how a new drug is approved, a drug needs to travel and pass through several steps before it is approved. It is also highly likely that a drug may have to adopt a unique route for getting approved.
The majority of the drugs will never reach the clinical trial phase. This means they will never reach the human testing phase and never garner the attention of the FDA for a review.
For a drug to be approved it must undergo the FDA’s strict mechanism of the evaluation process. During this evaluation process, everything about the drug is scrutinized starting from clinical trials to how severe the side effects of the drugs are and most importantly the parameters under which the drug is manufactured.
The different stages through which the drug is developed and reviewed
Tested on animals
First of all, a request known as an Investigational New Drug Application is submitted. Advice may be sought from the FDA before submission.
Different companies or research organizations may act as sponsors. The results of testing the drug on animals or preclinical testing are conveyed to the FDA along with a proposal on how they will benefit humans. The FDA then determines if it would be safe to test the drugs on humans.
Clinical trials
Once the FDA and an Institutional review board (IRB) have reviewed an IND, drug studies in humans can commence. The IRBs decide the clinical protocols which include a wide range of parameters from the type of people who will participate in the clinical trials to the procedures and schedule of tests and the medications and their dosages. Other details such as the length of the study and its objectives are also approved. The IRBs also ensure that the appropriate steps to protect patients from harm are taken and all participants have legally consented to the trials and are aware of the risks.
Phase 1 testing
This phase determines the side effects of the drug being tested and is conducted on healthy volunteers. 20 to 80 participants usually participate during this phase.
Phase 2 testing
Once the phase 1 testing does not exhibit any toxicity, phase 2 testing commences which focuses on determining the effectiveness of the drug. It determines if the drug is effective for a certain disease. Controlled trials are undertaken to compare how the drugs fare on patients who are taking the test drug in contrast to those who are undergoing a different treatment. The safety and side effects are also evaluated during this phase which consists of a few dozens to about 300 subjects.
Phase 3 testing
Once phase 2 testing establishes the effectiveness of the drug, phase 3 commences obtaining more information on safety and effectiveness. Different populations are studied with different dosages. The drug may also be used in combination with other drugs. The subjects number up to 3000.
Review meeting
The FDA approves a product for marketing following which sponsors agree to commitment studies and post-market measures. These studies are used by the FDA to collect more information about the drug and its safety and optimal use.
New Drug Application (NDA)
The sponsor sends the NDA to the FDA for considering the approval of the drug for marketing in the U.S. it contains all essential data related to testing on animals and humans. Other details such as the drug behavior in the body and its manufacturing are also included in the data.
Review of NDA
Following the receiving of the NDA, the FDA decides on filing or not filing the application for a review. In case the FDA decides on filing then a review team will be assigned the task of evaluating the sponsor’s research in the safety and efficacy of the drug.
Review of labeling
The drug’s labeling which contains the information regarding the use of the drug is reviewed by the FDA.
Inspection of facilities
The FDA inspects the facilities where the manufacturing of the drug takes place. This is a part of its approval process.
Approval or a complete response letter
Following the completion of all the above steps, the FDA reviewers will either approve the application or provide a complete response letter.
As one of the leading Life Science and Technology Consulting Service, we help companies transition through all phases of the FDA drug approval process effortlessly. We have helped numerous clients in all aspects of drug management such as the manufacturing process, FDA’s drug approval, and ensuring the drug’s safety and efficacy as part of our broad spectrum of general and specialized healthcare services.
