Strategic plan and proposed rule on early notification by manufacturers will help agency build on recent progress
The U.S. Food and Drug Administration 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.
“The complex issue of drug shortages continues to be a high priority for the FDA, and early notification is a critical tool that helps mitigate or prevent looming shortages,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA continues to take all steps it can within its authority, but the FDA alone cannot solve shortages. Success depends upon a commitment from all stakeholders.”
Early notification gives the FDA time to:
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.
“The complex issue of drug shortages continues to be a high priority for the FDA, and early notification is a critical tool that helps mitigate or prevent looming shortages,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA continues to take all steps it can within its authority, but the FDA alone cannot solve shortages. Success depends upon a commitment from all stakeholders.”
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.
Early notification from manufacturers about possible shortages, as requested in the President’s Executive Order 13588 of Oct. 31, 2011 and then codified into law in FDASIA, has enabled the FDA to work with manufacturers to restore production of many lifesaving therapies. Since the Executive Order, there has been a 6-fold increase in notifications to the FDA.
The notifications received under the existing requirements have resulted in real progress in addressing shortages. The FDA helped prevent 195 drug shortages in 2011 and 282 drug shortages in 2012, leading to a reduced number of new shortages in 2012. The expanded early notification requirements would further enhance the FDA’s ability to address issues prior to the occurrence of 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.
The strategic plan also describes efforts the FDA is considering to address the manufacturing and quality issues that are most often the root cause of drug shortages. These include:
- 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; and
- risk-based approaches to identify early warning signals for manufacturing and quality problems.
The FDA has established a separate docket for the public to provide comment on the proposed rule.
For more information:
- Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products; Proposed Rule
- Drug Shortages
- Biological Product Shortages
- Consumer Update
- Executive Order 13588
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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