FDA Finalizes Six-Month Drug Shortage Notice Regulation

Regulatory NewsRegulatory News | 08 July 2015 |  By 

A regulation proposed by the US Food and Drug Administration (FDA) in 2013 will take effect on 8 September, requiring drug and biologics manufacturers to notify the agency in advance of impending drug shortages.


In 2011, after several years of worsening drug shortages, the Obama Administration issued Executive Order 13588 – Regarding Prescription Drug Shortages calling for measures to improve the response to drug shortages through stronger notification requirements and expedited drug review.

At that time, however, FDA lacked the authority to require companies to give notice of coming shortages, so the agency relied on voluntary notification.

That changed in 2012 with passage of the Food and Drug Administration Safety and Innovation Act (FDASIA), which gave FDA the power to require companies to give notice of any "discontinuance or interruption of the production of life-saving drugs," at least six months before the interruption, "or as soon as practicable." FDA also was given the option of extending these requirements to biologics through subsequent regulation.

Additionally, FDASIA granted FDA the authority to issue letters of noncompliance when companies fail to notify the agency adequately of a situation that could lead to a drug shortage and mandated the creation of a list of drugs in shortage.

The Regulation

In November 2013, FDA came out with its proposed regulation to implement the drug shortage provisions of FDASIA, Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products.

Despite protests from generic drug and biologics manufacturers during the comment period, FDA is going ahead with the regulation as proposed.

Notably, FDA opted to include biologics (including vaccines) in the final version, subjecting them to the same notification requirements as drugs.

Second, the regulation still requires manufacturers of affected products to give FDA notice electronically six months prior to any event that would cause a meaningful disruption in the supply of a life-saving drug. If this is not possible, companies must notify FDA within five business days of the event's occurrence.

If a company fails to give adequate notice to FDA, the agency will issue a noncompliance letter, which will be posted publicly if a satisfactory explanation is not provided.

Generics manufacturers had been opposed to the five-day period, arguing "a fixed number of days to report an 'interruption in manufacturing' will result in significant over reporting … Given the nature of drug manufacturing, quality control, investigations, and many other variables … manufacturers constantly have interruptions."

However, FDA says it has "determined that [five] business days is adequate time" for a company to determine if an issue is "likely to lead to a meaningful disruption."

In the event a company wishes to contest a noncompliance letter, the agency says it will consider "whether the applicant had a reasonable basis for not notifying FDA within the required timeframe."


Federal Register


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