FDA Takes Action Steps to Resolve Drug Shortages
The FDA is working to build upon their efforts to prevent and resolve drug shortages. From 2011 to 2012, the number of new shortages decreased from 251 to 117.
The FDA is releasing a strategic plan as required by 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 to confront the underlying causes.
This plan also highlights ways for drug manufactures to prevent shortages by promoting and sustaining quality manufacturing.
In addition, the FDA proposed a rule requiring all manufacturers of certain medically important prescription drugs and biologic products to notify the FDA of a permanent discontinuance or a temporary interruption of manufacturing likely to disrupt their supply.
This proposed rule implements the expanded early notification requirements included in FDASIA.
Parts of the strategic plan 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
- updating the FDA's internal procedures for responding to early notifications of potential shortages
- broader use of manufacturing metrics to assist in the evaluation of manufacturing quality, as well as incentives for high-quality manufacturing
- internal organization improvements to focus on quality, including a proposed Office of Pharmaceutical Quality within CDER
- risk-based approaches to identify early warning signals for manufacturing and quality problems
For more information call (888) INFO-FDA or visit FDA.gov.