On the average, it takes as long as 12 years to gain approval from the FDA for any kind of medical drug. There is a long process and multiple people look over evidence to prove that the product they will be pushing out onto shelves will be helpful and effective, with no nasty side effects.
Firsta company has to develop the drug, and this goes for all kinds of medications including but not limited to diet pills. Once the diet pills are made, they go through about three and a half years of laboratory testing within the manufacturer‘s company where they test the chemical compounds against known data and test animals. The data found from these tests are sent with samples of the product to the FDA to begin testing the diet pills on humans. This process is so thorough that only 1 in every 1,000 of the compounds that were to become medications ever reach it to human testing within laboratories.
After the Green Light
Once it is approved by the FDA for a green light, then the investigations begin. There are three phases of testing in clinical trials. First they find 20 to 30 healthy people to volunteer, and about a year is spent with these volunteers to create a safety profile for the drug. This time is spent to find out if the drug is safe. Once that is done, they move the scale to 100 to 300 patient volunteers and test the drug for effectiveness. This series of testing takes around two years, and is used to make sure that the diet pill actually works. Phase three of this process amps up the numbers again, this time taking 1,000 to 3,000 patients who will greatly benefit from proper weight loss pills, and once again the effectiveness is monitored as well as any harmful side effects. This final phase of testing takes about three years, rounding it out to around six full years of FDA testing before a diet pill can be put on the shelves at your local store.
The Final Steps
Once all the testing has been completed the manufacturer will then fill out an application asking the FDA for approval. All the previously found data will be compiled in this report, and it can still take up to two and a half years to gain approval from this stage.
Once approval is finally given, then it becomes available to purchase in stores. This may seem like a long and hard process to endure, but it ensures (in theory) that each and every product sent out onto store shelves is safe, and reduces the amount of encounters with harmful side effects. Previously, when the FDA had fewer regulations and shorter waiting times in laboratories, diet pills were put on the shelf before any harmful side effects could be found. This made it so that the public who took them received these side effects, and the longer process is meant to stem the amount of these incidents.