What process does the FDA follow when determining whether to approve a drug?

FDA approval doesn’t actually take as long as most people think.  In a recent blog post, http://www.cancer-clinical-trials.com/2012/07/waiting-for-new-drug-to-be-approved.html we discussed the fact that FDA approval, at an average of 322 days, is actually a little faster than approval in Europe and Canada.  That’s not to say it’s quick, but it does not take years.  What takes a long time are all the studies necessary to collect the information the FDA requires to consider an application.  The FDA uses the “safe and effective” standard.  Effective means that cancer patients benefit in a meaningful way.  This often involves living longer, being cured of cancer, or experiencing quality of life improvements.  The FDA reviews all of the clinical trial data in detail to determine if these standards have been met.  This review takes several months.  While we all want cancer drugs to come to market as quickly as possible, it is also worth remembering that the FDA is held accountable when a drug is approved that later proves unsafe.  It’s a balancing act between moving quickly and dotting the i’s and crossing the t’s.

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(c) 2012 Tom Beer and Larry Axmaker