Summary
1. The FDA failed to review Takeda's new drug application for Alogliptin in a timely manner, despite being paid handsomely by Takeda to do so. 2. After causing the delay, the FDA then took advantage of that delay to add an extra requirement for approval of Alogliptin, which would not otherwise have applied to it. 3. The net result is a lengthy delay in approval of a promising new diabetes drug, which hurts patients, health care providers, and the very pharmaceutical industry we depend on for new drugs.
Analysis
The FDA was scheduled to decide regarding approval for alogliptin in Fall 2008, but it delayed the decision well past the end of the year, citing insufficient staff to deliver in a timely manner. Ironically, the lack of staff occurred despite the fact that Takeda had paid a large sum to the FDA, specifically to cover the cost of providind adequate staff to perform the required analysis. During the delay, created by FDA incompetence, the FDA then announced new criteria for new diabetes drug approvals, which alogliptin did not meet. Now Takeda is forced to do extra studies of effects of alogliptin on cardiovascular disease rates before, not after FDA approval. Thus, healthcare providers and patients are being denied a new diabetes drug, and Takeda is being denied due process. Sadly, the FDA is rarely, if ever, held accountable for adverse consequences of its decisions to patients, providers or the pharmaceutical industry.
