One issue that is unlikely to see resolution this year is the growing problem of drug shortages. As of October 2011, the Food and Drug Administration and the American Society of Health Systems Pharmacists found shortages of 168 drugs. According to healthcare analytics firm IMS Health, while this represents a small and highly concentrated portion of the overall drug market, it includes a number of critical drugs used to treat cancer, infections, cardiovascular disease, central nervous system disorders and pain. In addition, more than 80% of these 168 drugs are injectables and more than 80% are generics.
IMS VP industry relations Doug Long said one cause for the shortage was efforts by generic drug makers to move up the value chain and develop more specialized therapies. Many of the drugs experiencing shortages — some of which are 20 to 30 years old — are no longer profitable and thus no longer made. “I think the progress that we’ve made is identifying the causes of [shortages],” Long told Drug Store News.
Meanwhile, the Obama administration sought to address the problem with a rule issued last month that would require manufacturers that are the sole producers of certain drugs to report any interruptions in manufacturing to the FDA. The Generic Pharmaceutical Association also called for the creation of a new initiative to gather current and future supply information from various stakeholders for certain products and use the information to identify current and potential supply gaps, focusing on products with an expected shortage time longer than 90 days. IMS also recommended the creation of an early warning system for drug shortages that would include systematic risk identification, continuous long-term demand forecasting, creation of a supply volatility index and comprehensive predictive modeling.