Saturday, January 11, 2014

A drug shortage comment


The FDA recently solicited comments (Docket FDA-2011-N-0898 on regulations.gov) related to it "...  proposing to amend its regulations to implement certain drug shortages provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). The proposed rule would require all applicants of covered approved drugs or biological products—including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application—to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States."

A number of comments were submitted and most from healthcare providers were nods of approval regarding the advance notice requirements, for example:

American Society for Pediatric Nephrology ASPN: 


American Plasma Users Coalition A PLUS: 
 


American Hospital Association AHA:



American Society of Health-System Pharmacists (ASHP):


 American Medical Association AMA:
 


Comments by drug manufacturers were more nuanced... While supporting in principle the aims of the FDA they questioned various parts of the proposals (terms, definitions, time frames, etc.)

OK, so advance notification of upcoming disruptions or shortages to the FDA may give it time to look for solutions (asking other manufacturers to ramp up production, temporarily approving importation, etc.) but there need to be additional safeguards in place.  A hint of an upcoming critical drug shortage and the natural reaction of a hospital Pharmacy Department buyer will be to 'over-order' that drug to pad their inventory to protect his/her organization against a pending shortage. Enough of such transactions and the fear of a potential upcoming shortage will exacerbate the issue and immediately precipitate an actual drug shortage. 

It's human nature  (why would a Pharmacy staffer want to explain to the physicians why they ran out of a drug if they could have done something to avoid it?) and an example of the 'tragedy of the commons.' Doing what is in their individual best interest has negative consequences for others and the collective good...   

The bottom line? The notifications will have to be well coordinated with the major drug wholesalers, so that exactly as the notification hits the FDA the wholesalers either restrict sales to their customers to some approximation of their normal purchase volumes, or some other system to prevent "safety" purchases and hoarding!

Previous blog entries on drug shortages: 
Drug shortages - update - Nov 21st, 2013
Random charts - drug shortagesAug 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
The why's of drug shortages - Mar 3oth, 2011 

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