In my November 28th and December 3rd posts I introduced the media storm regarding the FDA's recent revocation of approval of Avastin for the treatment of breast cancer. Today I'll provide an overview of the FDA approval process to help us talk about the controversy.
Depending on the source of information, it takes on average ~12 years and more than $350 million for a drug company to get a new treatment from the laboratory to the pharmacy shelf.
After a few years of laboratory testing in test tubes and animals, the company manufacturing the investigational treatment applies to the U.S. Food and Drug Administration (FDA) for permission to begin testing the treatment in humans -- so-called clinical trials. Only ~one in 1000 of the compounds that enter laboratory testing ever makes it to this stage of testing.
Clinical trials are laborious and expensive. They involve four phases and take on average ~6 years to complete.
If the results are promising, the company submits an application to the FDA for approval, a process that can take up to 2 1/2 years.
After final FDA approval, the drug becomes available for physicians to prescribe. At this stage, the drug company will continue to report cases of adverse reactions and other clinical data to the FDA.
This overly brief summary doesn't begin to capture the time, effort and resources consumed by the process. My next post will offer a peek behind-the-scenes.