US FDA is taking two actions to further enhance the agency’s ongoing efforts to prevent and resolve drug shortages, a significant public health threat that can delay, and in some cases even deny, critical care for patients.
Following the President’s 2011 Executive Order on reducing drug shortages, the number of new shortages in 2012 was 117, down from 251 in 2011. Today’s announcements build on this work.
First, the FDA is releasing a strategic plan called for in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 to improve the agency’s response to imminent or existing shortages, and for longer term approaches for addressing the underlying causes of drug shortages. The plan also highlights opportunities for drug manufacturers and others to prevent drug shortages by promoting and sustaining quality manufacturing.
Second, the FDA issued a proposed rule requiring all manufacturers of certain medically important prescription drugs to notify the FDA of a permanent discontinuance or a temporary interruption of manufacturing likely to disrupt their supply. The rule also extends this requirement to manufacturers of medically important biologic products. The proposed rule implements the expanded early notification requirements included in FDASIA.
Early notification gives the FDA time to:
– work with manufacturers to investigate the issue leading to the manufacturing disruption;
– identify other manufacturers who can make up all or part of the shortfall; and
– expedite inspections and reviews of submissions from manufacturers of drugs that may prevent or mitigate a shortage.
The strategic plan, which was required by FDASIA and is being sent to Congress today, describes actions the FDA will undertake to improve its current efforts to respond to early notifications of a potential shortage. These include:
– improving the FDA’s communications about shortages, such as launching a new mobile app, so that individuals can instantaneously access drug shortage information via their smart phones;
– clarifying manufacturers’ roles and responsibilities by encouraging them to engage in certain practices that will reduce the likelihood of a shortage; and
– updating the FDA’s internal procedures for responding to early notifications of potential shortages.
Source: U.S. Food and Drug Administration, USA