Over the past three years, the federal government has taken steps to improve communication among the supply chain regarding potential drug shortages.
President Obama issues Executive Order 13588, requesting early notification from manufacturers about possible shortages of drugs that are life-supporting or life-sustaining, or that prevent debilitating disease. (The Executive Order was codified into law in July 2012.)
Obama also gave the FDA the authority to “take steps to expand its current efforts to expedite its regulatory reviews, including reviews of new drug suppliers, manufacturing sites, and manufacturing changes, whenever it determines that expedited review would help to avoid or mitigate existing or potential drug shortages.”
In the Executive Order, the President instructed the FDA to communicate to the Department of Justice “any findings that shortages have led market participants to stockpile the affected drugs or sell them at exorbitant prices. The DOJ shall then determine whether these activities are consistent with applicable law.”
The FDA reports that since the Executive Order was signed, there has been a six-fold increase in notifications to the agency.
To view the Executive Order, go to
The Food and Drug Administration Safety and Innovation Act, or FDASIA, calls for a strategic plan meant to improve the agency’s response to imminent or existing shortages, and create longer-term approaches for addressing the underlying causes of drug shortages.
FDASIA requires manufacturers of certain drug products to notify FDA at least six months prior to the date of the permanent discontinuance in the manufacture of the drug or an interruption in the manufacturing of the drug that is likely to lead to a meaningful disruption in the supply of that drug in the United States, or, if that is not possible, as soon as practicable, according to the FDA. Such drug products include those that are life-supporting, life-sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery. FDASIA excludes radiopharmaceutical products.
FDASIA provides FDA with enhanced authorities.
For example, the law:
- Broadens the scope of the early notification requirement by requiring all manufacturers of covered drugs to notify FDA of potential discontinuances. (The prior law applied only to sole manufacturers.)
- Makes clear that manufacturers are required to report discontinuances to FDA regardless of whether they intend to discontinue the product permanently or are facing only a temporary interruption of supply.
- Enables FDA to require, by regulation, mandatory reporting of shortages of biological products. (The prior law excluded all biological products from the reporting requirements.)
- Makes clear that the notification requirement applies to drugs that are used in emergency medical care or during surgery (if they are intended for use in the prevention of a debilitating disease or condition).
- Requires FDA to issue a non-compliance letter to manufacturers who fail to comply with the drug shortage notification requirements and to make the letter and the company’s response to the letter available to the public.
For more information, go to the FDA FDASIA Fact Sheet page at http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/Significant
October 2013: Strategic plan
FDA sends to Congress a strategic plan to address drug shortages, called for by the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. The strategic plan 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 smartphones.
- 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.
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.
- 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 the FDA’s Center for Drug Evaluation and Research.
- Risk-based approaches to identify early warning signals for manufacturing and quality problems.
- To view the strategic plan, go to
October 2013: FDA proposed rule
FDA issues a proposed rule requiring all manufacturers of certain medically important prescription drugs to notify the FDA electronically 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.