About Clinical Research

The Phases of FDA Approval for New Drugs

How does a drug get approved for sale?

Getting a new drug approved by the FDA requires much more than a clinical study. There are steps that need to be taken both before and after the study takes place to ensure that the drug meets FDA guidelines and will be approved for sale. The same principles apply to both prescription drugs and vaccines.

Before a drug company can test the drug on people, it must first conduct laboratory and animal tests to prove the drug is safe for human consumption. After these tests have completed, the company must submit an Investigational New Drug (IND) Application. The results of laboratory and animal testing will allow the FDA and the IRB (Institutional Review Board) to determine the safety of the drug in human trials. Once the FDA has approved the IND application, the drug company may begin to test the drug in humans to demonstrate the expected results.

The FDA is included in each phase of a clinical study. Once each phase has been completed, they will assess the results and decide whether the next phase can be launched.

What happens after the clinical trials are completed?

After the clinical study has been completed, the drug company will send the results to the Center for Drug Evaluation and Research (CDER) for review through a New Drug Application (NDA). The CDER, a division under the FDA that focuses on evaluation of new drugs, completes an unbiased review of the study results, deciding whether the benefits of the drug outweigh the observed risks. The CDER follows a specific set of guidelines to come to these results.

First, the CDER will research the disease being treated as well as other drugs that currently treat the disease. This creates a baseline for comparison with the new drug. If no current treatment options exist and the disease is considered serious or life-threatening, this is taken into consideration when weighing the benefits and risks of the new drug.

Second, the CDER assesses the study results. They look at both the benefits and risks of the drug and compare it to drugs that are currently available. Generally, two clinical studies on the new drug are recommended to prove that the study’s results are accurate, repeatable, and not based on chance.

Even if the CDER determines that the benefits of the new drug outweigh its risks, they will still look to lessen the risks and side effects of the drug. They will create an FDA-approved drug label that clearly defines both the benefits and risks, along with how these risks can be managed.

How long does FDA Approval take?

The FDA aims to take no longer than ten months from the time the NDA has been submitted to either approve or reject the new study drug.

Can FDA Approval be Accelerated?

The FDA may decide to accelerate the approval process if the new drug shows promising results for treating serious illness and is more reliable than other existing treatments. However, the drug company must conduct post-market trials which verify the benefits of the drug. If these trials do not show the expected results, the FDA may withdraw its approval of the new drug. An accelerated review from the FDA will take no longer than six months.

Why does it take so long to find a cure? 

Scientists and drug companies are racing to develop and test treatments and vaccines that address COVID-19, the disease caused by the novel coronavirus. Both treatments and vaccines are important for a strong and effective response to the outbreak. Treatments help people after they already have a disease. In the case of COVID-19, researchers hope to treat around 15 percent of COVID-19 patients who have more serious symptoms. Vaccines, on the other hand, help prevent people from getting sick in the first place. Vaccines are incredibly expensive to develop. From beginning to end, it can cost hundreds of millions of dollars to create a successful vaccine.

Finding a cure is always challenging. Developing a cure for COVID-19 is made more difficult because there has never been a vaccine for any type of coronavirus. COVID-19 is 10 times more lethal than the seasonal flu. The danger stems from the pathogen itself: a virus called SARS-CoV-2. Viruses are the most bizarre germs. Using just a handful of molecules, they assemble into all kinds of tiny shapes, and with just a small set of instructions, they can wreak havoc across entire ecosystems and threaten crop harvests. They can travel between hosts through the air, water, soil, and droplets. Most importantly they mutate.

Another factor that makes viruses so difficult to treat is how the body responds to them. Once the immune system detects a virus, it makes antibodies. These are proteins that attach to a virus or a virus-infected cell, marking it for destruction or preventing it from infecting new cells. Respiratory diseases, like COVID -19, in general, can be a little tougher because the vaccine must create a strong enough immune response in the bloodstream in order to activate antibodies in the respiratory tract. The problem is that a virus can cause a lot of damage and infect other people before the immune system readies its defenses. When those defenses kick in, they can cause other problems like fever and inflammation. And by the time these symptoms show up, the virus may already be in decline, or it may be too late to act in terms of treatment.

Because the illness is caused by a virus, researchers are testing antiviral medications to see if they can help treat sick patients. One drug, called Remdesivir, manufactured by Gilead Sciences, is currently being tested on more than 700 sick patients in Wuhan, China. A drug called Kaletra, produced by AbbVie to treat HIV is also being used on COVID-19 patients. Other patients are simply receiving supportive care, like oxygen through ventilators and blood pressure monitoring, while the body does its best to fight off the infection.

But before anyone can start hailing any miracle cures, proper clinical trials must be conducted. Controlled clinical trials are needed to determine if it is safe and effective for the treatment of COVID-19 infection. Even though experiments on COVID-19 vaccines have already begun, it could be dangerous to rush the steps that remain. Rushing things could result in a vaccine that’s harmful. There have been cases in the past in which people who received a vaccine got sicker when they encountered the virus itself. The safest development of drugs takes time. But people are currently working toward both treatments and vaccines, so in time, we should have both weapons against this virus.

How the FDA is Working to Fast Track Coronavirus Treatments 

In its all-hands-on-deck response to the coronavirus pandemic, the U.S. government is taking measures to make treatments accessible to patients as quickly as possible. This critical task is led by the Food and Drug Administration. 

As FDA Commissioner Stephen Hahn emphasized, the agency is working as fast as it can to give patients access to medications while still following protocol and ensuring safety standards.  

How the FDA is Speeding Up the Process 

Under normal circumstances, any pharmaceutical company seeking FDA approval to sell a prescription drug must successfully complete a complex and often time-consuming process: 

1. Discovery and concept 
2. Preclinical research 
3. Clinical research 
4. FDA review 
5. FDA post-market safety monitoring 

These steps are in place to maximize patient safety and ensure efficacy, but in a crisis like the COVID-19 pandemic, broad access to new medication must occur in a fraction of the time. As a result, the FDA is working to fast track clinical trials and review periods so that the most promising drugs become available within the next few weeks and months.  

As Hahn explained, “We are looking at everything that’s coming across our desks as treatment options for coronavirus. We need to make sure this sea of treatments will get the right drug to the right patient at the right dosage at the right time.” 

Sources

• https://www.fda.gov/drugs/development-approval-process-drugs#FDA 
• https://www.fda.gov/drugs/drug-information-consumers/fdas-drug-review-process-ensuring-drugs-are-safe-and-effective 
• https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review
• https://www.livescience.com/can-coronavirus-be-cured.html  
• https://www.abc.net.au/news/health/2020-03-19/coronavirus–drugs-and-vaccines-to-treat-and-prevent-covid-19/12067496 
• https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-facilitate-development-treatments 
• https://www.nbcnews.com/health/health-news/what-new-coronavirus-n1119081
• https://www.npr.org/2020/03/19/817971577/trump-governors-to-discuss-coronavirus-strategy-as-fema-takes-bigger-role 
• https://www.drugwatch.com/fda/approval-process/  
• https://www.nih.gov/news-events/news-releases/nih-clinical-trial-remdesivir-treat-covid-19-begins  
• https://www.gilead.com/news-and-press/press-room/press-releases/2020/2/gilead-sciences-initiates-two-phase-3-studies-of-investigational-antiviral-remdesivir-for-the-treatment-of-covid-19 
• https://clinicaltrials.gov/ct2/show/NCT04292730