U.S Food and Drug Administration are responsible for approving drugs for sale to the general public. Whatever drug is developed has to go through a series of steps to make it to the shelves. This process is overlooked by the FDA and no medicine or drag is allowed entry into the market unless it has been approved by the mentioned governing body.
For these drugs, extensive testing is conducted to see if they are fit for consumption at mass scale. Drugs are made readily available only after the developers or manufactures undergo a long and lengthy process that’s ensures the safety of the drug, whether it does what It claims to do, whether it is more effective than standard medical care facilities and how it stacks up to the alternatives that might be available to the public.
Preclinical tests are organized to see the efficacy of the new drug. First, rodents or animals are used to check the reactions and viability. The drugs that pass this very initial stage advance to the stages of Clinical trials.
Clinical trial is the practice in which humans are used to for the first time to check the drug. These trials may be short and may finish on schedule, but that does not mean that they aren’t to be taken seriously. These trials pave the way for future advancement and researches. They are basically the only way a drug or any new therapy may be tested to the limit. Since so much is riding on these practices, we can say, to an extent, the future is at stake. A lot of hard work, sacrifices and money goes into conducting them. They may take years and years to complete and present a final conclusion.
When it comes to medication, long term effects are a very serious aspect that cannot be overlooked when lives are at stake. The length of a clinical trial may be justified and adjusted according to this very aspect.
To achieve better results, often in a clinical trial, a dummy medication is given to one group and the actual drug to one group for comparative analysis.
Once a drug has come out of a clinical trial with positive results, FDA usually takes 6 months on average to either approve or reject a drug.
2011 was the last year for which information was made available by FDA. In that year, 35 new drugs were approved. According to estimates, currently 35-40 drugs are being subjected to scrutiny by the FDA.
Over the counter drugs do not have to go through the FDA lens to be available for public use. In some cases and for some certain classes, such as antacids, active ingredients are reviewed by the FDA to make sure that they are safe for consumption
When a company makes a drug, it is protected by law under a patent for 20 years. During which time no other company or brand has the permission to make that drug under their own banner. Once the patent expires, the same company or some other company may start producing the drug under a generic name.
Generic drugs are usually cheaper and are also tested by FDA for their effectiveness, quality and safety.