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Appendix 2: Comparison of Medical Product Shortage Activities in Selected FDA Centers

Table of Contents: A Review of FDA’s Approach to Medical Product Shortages

Product shortage reporting requirement Required to provide up to 6 months notification of discontinuation of certain sole-source drugs Similar to CDER for a small proportion of CBER-regulated products  No reporting requirement  No reporting requirement
Frequency of industry reporting on shortages Staff estimate under 50% of product discontinuations are properly reported to CDER Good cooperation and early notification received from manufacturers    Rarely, if ever.  CDRH often finds out about shortages from the media.  To obtain information, CDRH must contact the manufacturer directly  Rarely
Description of shortage problem About 30-40 shortages currently.  Number of shortages has increased significantly over last several years  Very few shortages (last reported in 1/2010) Limited information 6 active shortages currently.  Has been experiencing an increase in shortages  
Product most often involved in shortage Sterile injectables IVIG, vaccines Unknown Sterile injectables
Database of shortages that have occurred? Yes No; Access database in development No  Consolidated internal list of shortages 
List of shortages publicly available?  Does it include reason for shortage? Yes; List includes company/product, reason (general), and related information  Yes.  List includes product name, reason for shortage (general), and status  No No 
Is there a shortage plan in place?  Yes: MAPP Yes; SOPP 8506.
SOPPs for use within OCBQ currently being developed 
CDRH has Standard Operating Procedures to address device shortages  No.  In process of updating written procedures 
Have you used regulatory discretion in attempting to resolve shortages?  Yes.  Through expedited review, discretion with regard to distribution of particular lots, and importation  Yes.  Through expedited review and/or inspection of a facility  Yes  Yes, temporary regulatory discretion is considered, but extent of use is unclear 
Have you used importation as a solution to resolving shortages?  Yes; 3 new instances of importation in 2010 and 5 new instances to date in 2011 No  Yes Yes.  While the supplemental approval process is being reviewed 

 Next Section: Appendix 3: Potential Metrics to Include in Dashboard on Drug Shortage Program Web Site