19 April 2011

The Basics of How a Drug Gets FDA Approved

Let's start with an interesting question. If you had $ 500 million and were given the option to purchase either 1) of a professional sports team or 2) to pay for a drug through the FDA development process and then have this drug rightswhich would you choose? The average person has these two options are equivalent, but they are in reality.Obtain a drug approved by the FDA is much expensive, risky and time. Only one person in five drugs makes reality through the process, and the price to do so is formidable. If the drug makes it through and the disease, it deals with is fairly common, potential income can be enormous. To select the option 2 could pay much better than the team of professional sport. Most sports teams are proposals break even a year to year, but at least they are appreciating active which generate income.Once a drug is synthesized in the laboratory or purified from a natural source, the next step is usually animal tests. Common animals include mice or rats. This is called the preclinical testing phase, and if successful an investigational new drug application (IND) is subject to the food and Drug Administration (FDA). IND application is the Protocol for human trials. The FDA can challenge the Protocol, but if not after 30 days, the manufacturer can start the test.Clinical trials occur in 3 phases. Phase 1 gives the drug to healthy volunteers who do not have the disease dealt with subsequently. This is to verify safety and dosage. Once completed, Phase 2 is by giving the drug in patients with the disease also verify safety and side effects. Numbers in this phase are small.Phase 3 gives the drug to a large number of patients with the disease so that realistic statistical results is possible. Calendar of all 3 phases is an average of 5 years, but may be longer if it is a complex drug or if there is not that many patients with disease testing. The price tag may be more than 600 million for all 3 phases. Considering that 20% of the drugs actually make through the entire process, a pharmaceutical company looks on a real price tag of approximately 2.5-3 billion for success (4 drug failures over a drug successfully).After graduating successfully through Phase 3, the manufacturer submits an application for new drug (NDA) to the FDA. It is complete and contains all the results of the study. On average, the FDA 15 months needed to examine a NES. If approved, the FDA will give the drug "Indication on the label. The drug can be marketed to the indication given on the label, and if doctors deem it appropriate for other indications that they can prescribe it "Off-Label". An example of this would be gabapentin, with a brand name of Neurontin. Gabapentin was approved for epilepsy "sur-label" but it is commonly used "on the label" for the management of pain in patients with peripheral neuropathy.If a pharmaceutical company to obtain an additional Indication "on the Label" for drugs, they can submit an additional application to the FDA. It cost $ 10 million to $ 40 million.