Industry pundits like to point to the FDA list of new molecular entity (NME) and biological (BLA) approvals as proof that pharmaceutical industry innovation is on the wane. From a high of 56 in 1996, there has been a consistently steady drop in approvals, to a low of 18 in 2007. Since then, things have improved only slightly, with about 23 annual approvals on average. On the bright side, though, approvals through the end of August are up dramatically on a year-to-date basis.
But are new approvals really the only yardstick to measure productivity and innovation? By looking only at new molecule approvals, we overlook a lot. Many of the most important pharmaceutical product approvals are not found on the list of FDA-approved NME and BLA, but rather on the list of approved combination products and drug delivery enabled/enhanced pharmaceuticals. Individually, these products often match or exceed the therapeutic and commercial value of new molecular products, and, as we will see, the development of these products has managed to fill the gap created by the drop in new molecular approvals.A good example of the discrepancy in standards is evident in the assessment of innovation by an electronics sector company such as Apple Computer. Despite the success of products like the iPhone, iPad, and MacBook Air, the argument can be made that there really has been no innovation at Apple since the introduction of the iOS operating system that powered the first iPhone. There have certainly been important improvements and enhancements of the iPhone since then, but they are incremental, and built on the company's innovative iOS architecture. Similarly, the iPad is merely a line extension of the iPhone and the iPod Touch. Move along; there is no innovation here. With Macintosh computers, swap a solid state drive for a spinning hard drive, use the smallest components available, and voila!—the 'breakthrough' MacBook Air. Innovative or incremental?
The Pharma Standard of Innovation
As it now stands, the pharma standard of innovation is the approval of NMEs. By this yardstick, therapeutically and commercially important products like Advair and Duragesic are not innovative. Advair, a combination product, doesn't receive the innovation label because it incorporates previously approved active ingredients. But what a difference Advair has made to the lives of patients with asthma and COPD, and with cumulative sales of over $60 billion, Advair has financed much of the company's investment in innovation. Duragesic, another breakthrough product and huge commercial success, also fails the innovation test because it is a drug-delivery-enhanced formulation of a previously approved active ingredient.
Examples of other 'non-innovative' drug-delivery-enhanced pharmaceuticals (DDEPs) include Procardia XL, Concerta, and Suboxone. These products all incorporate well-validated pharmaceutical active ingredients put to different or better use through the creative application of drug delivery technology.