The PDUFA user fees all rose, not much of a surprise!  However, we are now getting into some serious money to submit a new NDA.  These fees could (in some instances) deter smaller applicants from entertaining NDA submissions as they might price them right out of the market. 

And if it is not the NDA filing fee that poses a problem, then maybe it will be the program fee that has that effect.  The program fee is a charge that applies to each strength of an application, up to a maximum of five.  Thus, while the NDA application fee is a one-time fee, the program fee is a yearly fee for maintenance of the application.  A firm that has an NDA with multiple strengths could, therefore, be paying up to a total of $2,083,670 a year if they had five strengths in their application. 

Just imagine, if you will, a product that has a $2 million program fee associated with it each year.  That means that the product would need to sell that amount just to break even on the fees.  Take into account manufacturing costs, component costs, packaging, labeling, and distribution costs, as well as labor, and you can see that a smallvolume niche product might not be worth the investment. 

Well, enough of the “what if”s and “how come”s!  As they say in the business, “it is what it is!”