One of the hottest topics over the last few years has been that of drug shortages and what to do about them.  The FDA video (here) explains that the Food and Drug Administration Safety and Innovation Act (FDASIA) made important changes to the way industry must report drug shortages.  In addition to the previous requirement under the FD&C Act of reporting permanent discontinuance of a drug product, FDASIA now requires the reporting of temporary interruptions in supply.  FDASIA also now includes a requirement for reporting of potential discontinuance or temporary interruptions in the supply of biologic products which were not included under previous statutory requirements.  The current law also provided FDA with an enforcement tool, the issuance of a non-compliance letter, to firms not complying with the reporting requirements.

The FDA explains that it does have various formalized methods in dealing with drug shortages, which include:

  • Working closely with sponsors to resolve manufacturing issues
  • Expedite inspections and reviews
  • Identify alternate manufacturers capable of increasing supply
  • Review data to potentially extend expiration dating of current inventories
  • Provide regulator discretion for the temporary importation of a non-US approved product

FDA has employed all of these options over the last few years.  Obviously, the last bullet describes option of last resort, but as was the case with the propofol shortage a necessary temporary fix.

All firms should be aware of the reporting requirements of FDASIA and the options necessary to avert or alleviate a drug shortage, so they can respond quickly to prevent or mitigate the impact of a shortage.  For further information or advice on reporting requirements or dealing with FDA on a drug shortage issue, please contact Joan Janulis at