FDA Releases Final Drug Shortage Notification Rule

On July 8, 2015, the Food and Drug Administration (FDA) released a final rule on “Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products,” which sets new rules to address drug shortages. The final rule requires that manufacturers of biologics, including plasma-derived products and their recombinant analogs, notify the FDA if they anticipate a permanent discontinuance of manufacturing or an interruption in manufacturing that leads to a “significant disruption in supply” for its products, regardless of how large or small the market share for the product is. Notification is required at least 6 months in advance of an anticipated discontinuation or shortage or no later than 5 business days after a permanent discontinuance or interruption occurs.

Taking effect on September 8, 2015, the rule provides an important vehicle for the FDA to address, prevent and/or mitigate shortages of drugs and biologics. More information about drug shortages may be found on the FDA’s website, where lists of all drugs and biologics currently in shortage may be found. Individuals can also sign up to receive information about shortages in drugs and biologics in specific products or therapeutic areas on the FDA website. There is also an app available for free download via iTunes and the Google Play store (search for FDA Drug Shortages).

This is a success for ASH, which advocated for inclusion of all biologics, including plasma-derived and recombinant products, in the advanced notification system in its comments to the proposed rule. While others argued that existing, voluntary systems were sufficient for capturing this information, the FDA disagreed, stating that this new requirement is not duplicative and that “it would benefit the public health for the Agency to receive direct notification under this rule from all manufacturers of these products.”