Over the past five years, the United States has seen record high drug shortages each consecutive year. In fact, in 2011 there were over 250 drug shortages compared to 211 in 2010. More alarming is that roughly 75% of the drugs are injectables that are used in life saving procedures. Everything from anesthesia for surgery to critical cancer treatments were affected. In a country where excess is the norm, the obvious question is, “why are there so many drug shortages”? The answers are pretty straightforward but may be surprising. According to a recent FDA webinar regarding drug shortages, the top three reasons are:
- 54% due to product quality/significant cGMP issues (e.g., particulate, contamination, impurities)
- 21% due to delays or capacity issues at the manufacturing facility
- 11% due to discontinuations of drugs
It is alarming that the majority of drug shortages are due to quality issues. Over the last 12 months, several generic drug manufacturers have completely shut down their processing lines while working to fix their problems. With major drug manufacturer consolidation happening in the pharmaceutical market today, this leaves few companies as viable options to pick up where another company left off.
So, what is the FDA doing to help alleviate the drug shortage problem? The FDA has been very proactive in working with drug companies to help relieve the shortages. They are working with individual firms to address the quality issues and have been uncharacteristically flexible in order to divert any significant risks to patients. The FDA can expedite clearance of alternative supplies of drugs from unapproved sources. For example, when propofol was unavailable, the FDA approved temporary importation of propofol from non-U.S. sources. Overall, the strategies used by the FDA have led to the prevention of shortages for over 100 drugs in 2011.
Drug manufacturers are not required to notify the FDA or wholesalers of impending drug shortages. However, manufacturing firms are getting better at alerting the FDA when the possibility of a drug shortage arises. The proactive roles of both the FDA and the manufacturers are helping curtail further drug shortages that will ultimately save lives and hopefully avoid yet another record setting year for shortages in 2012.