Fact Sheet: Drug Products in Shortage in the United States
On July 9, 2012, the president signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. In the new law, Congress provided FDA with new authorities to combat shortages of drug products in the United States and imposed new requirements on manufacturers regarding early notification to FDA of issues that could lead to a potential shortage or disruption in supply of a product.
Prior to FDASIA, sole manufacturers of certain drug products for serious conditions were required to notify FDA of a discontinuance of those products. FDA received notifications from other manufacturers about potential shortages of other products on a voluntary basis. Under FDA’s authority before FDASIA, if FDA learned of a shortage or potential shortage, FDA was able to use the following tools to prevent or mitigate the shortage:
- Work with sponsors to resolve manufacturing and quality issues contributing to the short supply;
- Expedite FDA inspections and reviews of various submissions from manufacturers to alleviate the shortage;
- Identify additional manufacturers willing to initiate or increase production;
- Help firms to qualify new sources of raw material when faced with a raw material shortage;
- Exercise enforcement discretion, in rare instances, for the temporary foreign import of a product in shortage; and
- Exercise enforcement discretion in appropriate circumstances to permit the distribution of a product in shortage, if this would not cause undue risk to patients (for example by allowing a product with particulate matter to be distributed with the use of a filter to eliminate the particulates).
Using these authorities, FDA prevented 195 shortages in 2011 and almost 100 shortages during the first half of 2012. Early notification from manufacturers of any issue that could lead to a potential disruption in product supply has been, and will continue to be, critical to preventing or mitigating drug shortages.
FDASIA provides FDA with important new authorities that will help the Agency combat drug shortages. The enhanced authorities include the following:
- FDASIA 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.
- FDASIA 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.
- FDASIA enables FDA to require, by regulation, mandatory reporting of shortages of biological products. The prior law excluded all biological products from the reporting requirements.
- FDASIA 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).
- FDASIA 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.
In addition to these new authorities, FDASIA includes the following provisions related to drug shortages:
- FDASIA requires FDA to submit an annual report to Congress on drug shortages and FDA’s efforts to address shortages.
- FDASIA requires FDA to establish a task force to develop and implement a strategic plan for enhancing our response to drug shortages. The strategic plan must be published and submitted to Congress within one year after enactment of FDASIA.
- FDASIA requires that, prior to taking any enforcement action or issuing any warning letter that reasonably could be anticipated to lead to a disruption in supply, appropriate offices within FDA communicate about the action and evaluate the relative risks and benefits to patients from the shortage and enforcement action or warning letter.
- FDASIA expressly states that FDA may expedite review of certain applications and expedite inspections that could help to mitigate or prevent a shortage.
- FDASIA requires FDA to maintain a publicly available, up-to-date list of drugs in shortage, including the cause and estimated duration of the shortage.
- FDASIA requires that if a shortage involves a controlled substance, if FDA determines it is necessary, FDA must notify the Drug Enforcement Administration (DEA) of the shortage and request that DEA increase the quota of the product to alleviate the shortage.
- Under FDASIA, a hospital is not required to register with FDA as a manufacturer solely because the hospital repackages drugs declared to be in shortage for use within hospitals within the same health system and if done in response to the shortage to extend the hospital system’s supply of the product.
- FDASIA requires FDA to establish a mechanism to allow health care providers and other third parties to report evidence of a product shortage to the Agency.
- FDASIA requires a GAO report examining the causes of drug shortages and formulating recommendations to prevent or alleviate shortages.