Some of the nation's top drug researchers have questioned the FDA's growing use of "approvable" letters that delay a final decision on a drug candidate. For drug companies, approvable letters often incite the wrath of investors concerned by the agency's unwillingness to issue an outright approval. Dr. Steve Niessen of the Cleveland Clinic complains that expert panels always make their deadline on a decision and the agency should as well. The FDA has 6 to 10 months to formally decide on a drug submitted for approval, but can extend that process up to six more months through the approvable letter. Part of the reason for the increased use of the letters may be because the agency is understaffed, but some also say the FDA is increasingly risk averse after a series of fiascoes involving drug safety.
- here's the article on the approvable letters from BusinessWeek