Monday, February 10, 2014

Latest drug shortage update

Today the Health Subcommittee of the House Energy and Commerce Committee held a hearing on 'Examining Drug Shortages and Recent Efforts to Address Them.' See video here...

The testimony  from the GAO and FDA discussed the issue, quantified it, and spoke of efforts to combat drug shortages...The main reasons cited (GAO) for shortages? "... quality problems resulting in supply disruptions and constrained manufacturing capacity...", suggestions that "... changes in FDA inspections of manufacturing establishments also played a role...", and "... a number of additional factors that can cause supply disruptions and ultimately result in shortages —such as permanent product discontinuations or the unavailability of raw materials."  

The reason for all the quality problems? GAO testimony mentioned studies that point towards "...underlying causes generally suggested that such causes led to low profit margins, which limited infrastructure investments or led some manufacturers to exit the market." And when one manufacturer has a problem there usually isn't enough spare capacity in the system for the (few) others to make up...

The GAO's recommendations?  That the FDA "develop policies and procedures for the use of the existing drug shortages database (and, ultimately, the new drug shortage information system) to ensure staff enter information into the database in a consistent manner and to ensure the accuracy of the information in the database; and,conduct periodic analyses using the existing drug shortages database(and, eventually, the new drug shortages information system) to routinely and systematically assess drug shortage information, and use this information proactively to identify risk factors for potential drug shortages early, thereby potentially helping FDA to recognize trends, clarify causes, and resolve problems before drugs go into short supply."

Recommendations that may be characterized as fairly "generic."

The main reasons cited (FDA) for shortages? "... In 2012, for example, based on information collected from manufacturers, FDA determined that 66 percent of production disruptions leading to a shortage resulted from either (1) efforts to address product-specific quality problems (31 percent) or (2) efforts to address broader problems at a manufacturing facility (35 percent)." Also mentioned: product discontinuations (for economic reasons), natural disasters, and problems with raw materials availability... 

Finally, beyond working on measures to improve their response when shortages are already on their way (when the FDA is notified of production disruptions), the FDA is also looking for longer-term fixes, e.g. "... a focus on encouraging and sustaining improvements in manufacturing quality... encouraging development of techniques that can help advance drug manufacturing... actions to encourage manufacturers to adopt new manufacturing technologies, to facilitate their use of modern quality management techniques, and to ensure that FDA regulatory policies reflect state-of-the-art manufacturing science..."

Previous blog entries on drug shortages: 
A drug shortage comment - Jan 11th, 2014 
Drug shortages - update - Nov 21st, 2013
Random charts - drug shortages Aug 10th, 2013
Follow up (drug shortages) - Jul 5th, 2013
Random charts - drug shortages - Jan 31, 2013
Random charts - drug shortages - Jul 25th, 2012
Diagnosis - muddled thinking - Jan 21st, 2012
Polarization? - Dec 2nd, 2011
Help on the way? - Jul 31st, 2011
Random charts - Apr 6th, 2011

And a 2011 reprint of a 2002 entry with a dozen  real-life examples of reasons for drug shortages:

The why's of drug shortages - Mar 30th, 2011

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