FDA in the Hot Seat
Although the FDA has good intentions, it is often scrutinized for the amount of time it takes to review submissions, approve clinical trials and the like. And today is no exception. Expertbriefings.com released an article, “How the FDA Stifles New Cures, Part 1: The Rising Cost of Clinical Trials,” in which it addresses how outdated policies are making drug development too expensive and too risky http://www.expertbriefings.com/news/how-the-fda-stifles-new-cures-part-i-the-rising-cost-of-clinical-trials/). The article reviews various factors blamed for driving up the cost of clinical trials, including the cost of drug development and “phase III” trials. Says the author, “My Forbes colleague Matthew Herper recently totaled R&D spending from the 12 leading pharmaceutical companies from 1997 to 2011, and found that they had spent $802 billion to gain approval for just 139 drugs: a staggering $5.8 billion per drug…The biggest driver of this phenomenal increase has been the regulatory process governing Phase III clinical trials of new pharmaceuticals on human volunteers.”
What are your thoughts or concerns regarding the FDA and its processes?