Is FDA Reporting Drug Shortages Adequately?
For a number of years, there has been a problem of shortages of certain generic drugs for injection. These are often important cancer drugs. In 2012, I wrote a report that concluded over regulation by the Food and Drug Administration (FDA) was the primary cause of the shortages.
The President and Congress acted, but their actions did not result in improvement for over a year.
Today, the FDA claims to have improved the situation. However, an article in Health Affairs points out that the number of drug shortages reported by the FDA and the number reported by the University of Utah Drug Information Service (UUDIS), the leading private source of this data, are diverging dramatically:
On other measures, the picture seems more confusing. At the onset of 2015, the UUDIS was tracking 301 active shortages, an increasing trend reported in a 2014 Government Accountability Office (GAO) study and later reflected in a Health Affairs health policy brief. Yet during a 2014 Congressional hearing on the topic, the FDA presented statistics showing that the number of active shortages is going down.
These statements reflect the numbers on the FDA drug shortage website, which listed 82 active shortages at the onset of 2015, down from 121 shortages two years earlier. The two organizations, the FDA and UUDIS, work closely together and communicate regularly about arising problems and resolved shortages. Why is it then that their numbers are at different levels and facing diverging trends? In this blog entry, we discuss how the FDA’s list of shortages represents a subset of a broader list of supply disruptions listed by the UUDIS. (Marta Wosinska, et al.)
That is quite a difference: 301 shortages versus 82 shortages. This is a strange development. I had not noticed it when I wrote my study in 2012. Indeed, a UUDIS source I quoted reported 210 shortages in 2011. So, it looks like shortages are getting worse by that measurement.
I hope this confusion does not mean the FDA is moving the goal posts in response to heightened Congressional oversight of this situation.