FDA FOCUS: FDA Regulations and Drug Shortages in America

In the first of a new monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola Davies looks at whether stringent FDA regulations are causing drug shortages.

Drug shortages have been an ever-growing and critical concern in the American medical landscape over the last decade, and continue to persist despite several efforts by the government to ease shortages.

As noted in the US Government Accountability Office’s 2014 report on the Food and Drug Administration’s response to the problem, the number of shortages began to grow in 2006. The problem started with 56 shortages, followed by 154 in 2007, 193 in 2008, 231 in 2009, 328 in 2010, 439 in 2011, and 456 in 2012. In a study conducted by Ventola (2011), the drugs most vulnerable to shortages were, and continue to be, oncology medications, injectable drugs, generic drugs, drugs subject to the FDA’s Unapproved Drugs Initiative, and single-source products with concentrated market share.