Monday, January 18, 2016
Pharmaceuticals blogger Derek Lowe recently pointed
to an interesting
article detailing how an FDA drug approval process is causing
generic drugs to increase in price, sometimes dramatically. Lowe
quotes from the Journal of the American Medical
In a competitive market, when a price is too high, another manufacturer could begin to produce and offer the product at a lower price. However, because there is an approval process to ensure bioequivalence and quality manufacturing, this self-correction can happen only at the speed of FDA review. FDA is now working on reducing a massive backlog of thousands of generic applications from prior to 2013. The agency's fiscal year 2014 performance report noted that none of the approximately 1500 applications for generic drugs submitted in fiscal year 2014 had been approved by the end of that year. Even with greater resources as a result of the Generic Drug User Fee Act, FDA will still take years to review these applications. [Lowe's emphasis]Those of you who frequent this neck of the woods will doubtless be familiar with the FDA's practice of denying patients access to experimental drugs even when they might represent a last hope. But one clearly needn't be terminally ill or in need of cutting-edge medication to be concerned about this agency's interference with the economy. Lowe mentions a past drug shortage (and I remember another) that could quite feasibly have been at least partially the result of this problem.