(Graphic: Capsule held between finger and thumb) Patient care is our primary concern. Since 1999, FDA has worked with the pharmaceutical industry and stakeholders to address this critical issue that impacts health care delivery in the United States.
(Graphic: Gloved hand injecting liquid through syringe into an IV)
Types of Drugs FDA Considers for Drug Shortages
(Graphic: Prescription pad) FDA prioritizes drugs that are medically necessary. A medically necessary drug product is a product that is used to treat or prevent a serious disease or medical condition for which there is no alternative drug, available in adequate supply, that medical staff has determined to be an acceptable substitute. Although the agency focuses on medically necessary drugs, all potential shortages are evaluated to help determine the possible public health impact.
Reasons for Drug Shortages
(Graphic: Pie Chart)
Raw Materials 27%
Quality Manufacturing Issues 37%
Quality: Delays/Capacity 27%
Loss of Manufacturing Site 2%
Increased Demand 5%
FDA Works to Prevent Drug Shortages
(Graphic: Person looking through telescope) FDA works to find ways to mitigate drug shortages. However, there are a number of factors that can cause or contribute to drug shortages that are outside of FDA's control. Sometimes manufacturers have an unforeseen breakdown in manufacturing line that affects their production. Other times, shortages are caused by longstanding quality manufacturing issues.
FDA cannot require a pharmaceutical company to:
- make a drug, even if it is a medically necessary drug,
- make more of a drug,
- change how much and to whom the drug is distributed.
(Graphic: Notebook titled Strategic Plan) FDA issued a long-term strategic plan to outline the agency’s priority actions, as well as actions drug manufacturers and stakeholders can take to prevent drug shortages by promoting and sustaining quality manufacturing.
FDA Responds to Drug Shortages
(Graphic: Gloved hand holding IV) FDA responds to potential drug shortages by taking actions to address their underlying causes and to enhance product availability. FDA determines how best to address each shortage situation based on its cause and the public health risk associated with the shortage.
FDA works to maintain availability of a drug in a variety of ways, while minimizing the risk to patients.
For manufacturing/quality problems, FDA works with the firm to address the issues. Problems range from very low risk, such as the wrong expiration date on package, to high risk, such as particulate in product or sterility issues.
FDA also works with other pharmaceutical companies making the drugs that are in shortage to determine if they have the capacity to assist and if they are willing to do so.
When the U.S. manufacturers are not able to resolve a shortage immediately and the shortage involves a critical drug needed for patients, FDA may look for a pharmaceutical company that is able to redirect product into the U.S. market to address a shortage. FDA considers a list of criteria to evaluate the product to ensure efficacy and safety, including the formulation and other attributes of the drug, as well as the quality of the manufacturing site where the drug is made.
The Pharmaceutical Industry Can Help Prevent Drug Shortages
(Graphic: IV in patient's wrist and a syringe) While FDA and industry has made progress, patients are still experiencing drug shortages that impact their care. A high percentage of drug shortages have been, and continue to be, sterile injectables, including chemotherapy, anesthesia and other acute drugs. When there are quality or production problems for sterile injectables, it is not uncommon for a shortage to occur. FDA will continue to work with manufacturers and other stakeholders to ensure that needed medicines are available to the American public.
For more information on drug shortages visit the FDA Drug Shortages Web page.
U.S Food and Drug Administration