According to a survey conducted by the federal government, almost half of all Americans over the age of 12 take pain relievers, sedatives, stimulants, or some form of prescription drugs. Due to such a mind-boggling number, it comes as no surprise that the process to get any drug approved requires years of testing and millions of dollars. And rightly so. After all, not having a firm procedure for testing and developing pharmaceutical drugs could easily give rise to unexpected side effects or even death. So, when it comes to the United States, what do developers have to go through to get their drugs approved?
It All Begins in a Lab
To better understand what companies have to do, consider Vilvet Pharmaceutical. This innovative developer has been in the business for years and focuses on innovating, developing, and manufacturing various forms of drugs. Thus, they have been a part of the process enough times to attest to the detailed breakdown of it.
Well, the first step always takes place in a laboratory where researchers and experts spend time doing a few different things. First, they identify the key factors hiding behind a particular disease or a condition. Then, they look for chemical solutions that could help combat these factors. The purpose of this preliminary research is to identify all possible components, which could add up to thousands of unique compounds that could be used as solutions.
Upon the completion of the stage for preliminary findings, researchers narrow down their solutions to the disease in question to about a dozen alternatives deemed to be the best fit. This process tends to take about 4-5 years as high-quality research demands unparalleled attention to detail and enormous manpower.
Those dozens or so compounds identified in the first stage are subsequently moved to the second stage where their overall safety is tested. Since there is still no proof that they are safe at all, there can be no humans involved in the testing process. Instead, they are administered to animals, commonly rats, whose behavior is observed, and health monitored. The length of animal tests ranges based on the drug and might take anywhere from a few years to a few decades. Those compounds that hurt the animals in any way are immediately removed from the process, and their further use for the objective is terminated. The ones that prove worthy move on to the next stage where tests are expanded.
Expanding the Tests – Human Trials
The third stage of the development process is easily one of the more intense periods in the life cycle of new drugs. The reason why is that the researchers and experts will administer the compound to humans. Initially, the groups will be quite small, seldom exceeding 100 volunteers, because the risk needs to be minimized. Due to the varying group sizes, the third stage is often divided into multiple phases where the number of volunteers is slowly expanded. So, if a compound clears the first stage with anywhere from two dozen to about a hundred subjects, it goes to the next one where as many as 500 people are given the drug.
Getting the Final Approval
Upon the completion of a multi-year testing stage on the human population, drugs, and all of the accompanying paperwork are sent to the Food and Drug Administration (FDA). Vilvet Pharmaceutical states that it normally takes anywhere between six and ten months for the FDA to complete their review. This includes thoroughly going through every single stage and verifying that the research, trials, and overall development conducted have been done appropriately to where there is tangible evidence that the drug is safe and effective. If the FDA approves the drug, the developers are allowed to begin marketing, filing for patents, and selling the drug to the public.
Filling for Patents
Since the process to develop a new drug can cost hundreds of millions of dollars and take over a decade to complete, virtually every single developer will file for a patent. This is a form of protection against anybody else trying to copy the drug formula for 20 years. Upon the expiration of those two decades, however, other producers will become eligible to make generic versions of the drug, and the original developer will need Congress to approve their patent renewal. In reality, however, that rarely happens.
In the end, Vilvet Pharmaceutical stresses the importance of continuously monitoring the drug after it has been released. This is because there might be side-effects that remained uncovered during the development stages. So, while the large portion of the work is completed, there is still a plethora to be done even after the compound becomes an FDA-approved drug.