On November 4, 2013, FDA issued a proposed rule regarding manufacturer notification to FDA of drug shortages due to a permanent discontinuance or unplanned interruption in manufacturing. The FDA Safety and Innovation Act (Act) required FDA to promulgate the proposed rule, and ultimately the final rule, by January 9, 2014. Under the Act, all manufacturers of certain drugs and biologics must notify the FDA six months in advance of a drug or biologic shortage in order to aid FDA’s efforts to prevent, mitigate and publicize these shortages. FDA’s recent activity stemmed from 250 drug shortages in 2011, and 117 shortages in 2012. FDA believes these shortages likely caused prescriptions of second-rate alternative drugs and biologics that could have resulted in greater risks for patients.

  1. The notification requirements apply to certain manufacturers and FDA applicants, including:
    1. manufacturers that are not subject to an NDA or an ANDA;
    2. certain applicants with an approved NDA or ANDA for a drug product; and
    3. certain applicants with a BLA for a biologic product or for blood or blood components for transfusion.
  2. FDA requires notification when either:
    1. the manufacturer will permanently discontinue the product; or
    2. when an interruption in production will likely lead to a non-negligible reduction in supply causing the manufacturer to fail to meet demand.
  3. Electronic notification shall include:
    1. the estimated duration of the interruption or whether there is a permanent discontinuance or interruption of the drug supply; and
    2. an explanation of the reason for the permanent discontinuance or interruption.
  4. In addition to the basic six-month notification requirement, if there is an unplanned or emergency shortage, notification must occur no later than five business days after the determination of the shortage. Finally, if an applicant fails to notify FDA of a shortage, FDA will send a noncompliance letter to the applicant. The applicant must respond within 30 days setting forth the reason for noncompliance along with the appropriate notification required by the rule.

In conjunction with the proposed rule, FDA also developed a strategic plan for the prevention and mitigation of drug shortages. In the strategic plan, FDA identified two central goals to address shortages: (1) improving the mitigation response to imminent or existing shortages; and (2) implementing strategies for the long-term prevention of shortages by focusing on the root cause of shortages. FDA identified specific tasks to meet those goals and specific areas in which FDA will seek external stakeholder attention. Overall, the FDA believes “early and open dialogue between FDA and manufacturers is critical to successfully mitigating and preventing shortages.” The proposed rule is an attempt by FDA to require the dialogue it believes is critical for successfully mitigating and preventing shortages.

The comment period for this proposed rule ends on January 3, 2014.