Have you ever wondered where your pharmaceutical drugs come from? How about the amount of testing they go through in order to become legalized in the United States? Maybe you have had issues such as joint pain, and are wondering how safe FDA drugs truly are. Well, according to the U.S Drug and Food Administration, there are five important steps in the process of creating new prescription medications.
The first stage of FDA approval: Discovery and Development
The first step to creating a new drug is the discovery and development phase. Typically, a new drug is discovered to combat some sort of disease. If new insights are discovered about that disease then there is a good chance that they will be able to create a new product that will either stop or reverse the effects of it. The main goal of a product is to get through initial early testing so that it can move on, into the second part of the first stage. During the development of a new drug, the developers decide what the right dosage would be, how it will be administered, how it interacts metabolically with different types of people and its negative/positive effectiveness as compared to other drugs.
The second stage of FDA approval: Pre-clinical Research
The second stage of creating a new prescription medication is the pre-clinical research stage. During this stage the discovered and developed drug is then transported to a lab to be further tested. A very important thing to note is that drugs rarely ever stay in the same place that they were created. Therefore it is vital that they are transported safely to reach their many different destinations of testing.
Many drugs require different forms of regulatory compliant storage, transport, management and a variety of temperatures. An example of the type of company that would normally transport these drugs would be classified as laboratory movers. They would be responsible for making sure all the drugs are transported without being contaminated, or destroyed. Once a drug is safely transported to the testing lab it is tested to make sure that it won’t cause serious harm to anyone. The specific thing they look for during this stage is the drug’s toxicity through in vitro or in vivo research methods.
The third stage of FDA approval: Clinical Research
The third step in creating a new drug is the clinical research stage. During this stage, clinical trials are designed and conducted on humans. This process is vital so that long and short term effects can be reported about the drug. Without this experimental stage, the FDA would not know if a drug is significantly effective either.
The fourth stage of FDA approval: FDA Review
After a drug successfully makes it through the clinical research stage, it then enters into the fourth step, the FDA Review stage. During this time, a new drug application is submitted to the FDA so that it can be reviewed by the FDA advisory committee. This application includes everything from proposed labeling, safety updates, drug abuse information, and patient information to the directions for use of the drug. After this application is sent, the FDA can decide if it is complete or not. If it is not complete, they can refuse the application. If it is accepted as a complete application, it then takes 6 to 10 months for the committee to decide if it is approved to become a drug.
The fifth stage of FDA approval: Post Market Safety Monitoring
After a drug is approved by the FDA, it reaches its fifth stage. This stage is called Post Market Safety Monitoring. Because of the fact that it is impossible to know the full extensive drug safety from clinical trials, the FDA keeps tabs on its drugs. For example, if any changes are needed to make to the drug more effective, the developers must submit a supplemental application to be re-reviewed by the FDA. They would also have to check with the FDA before they are allowed to use the drug to work against any other diseases that may benefit from it.
How do I know that the FDA is trustworthy?
One way to ensure safety of products being made is by the FDA’s manufacturer inspections. These inspections may be announced or by surprise so that the FDA knows if its manufacturers’ facilities meet the minimum safety standards. Another way that the FDA helps to protect patients is by regulating the advertising and promotion of drugs by the designers. The FDA is very particular about what they allow to be said on advertisements. They do not allow advertisements to be false or misleading. In addition to that, an advertiser is prohibited by law to advertise for unauthorized uses of their product.
What about Generic Drugs?
The good news for the creators of new drugs is that they are provided a patent for their drug for a certain amount of time. During this time, no one else is allowed to create a generic version of their drug. After the patent ends, competitors are allowed to create generic versions of the drugs to sell for cheaper. The FDA requires that the generic drug has the same dosage form, strength, safety, quality, performance characteristics, and intended use. However, since the generic drug is comparative to the original, it does not have to go through the same clinical trials as the original did. Luckily, since a generic drug is required to be so similar, consumers do not have to worry about if it is as safe or as effective. Although some may prefer the original over the generic drug, there is really no difference overall. Looking at all this information, one can be reassured that the FDA takes their drug creation process very seriously and that as consumers we can trust the FDA.