I came to FDA in 1999 after working for the Indian Health Service as a clinical pharmacist for 9 years. The Drug Shortage Staff at FDA was being formed at that time due to concerns with Y2K when there were anticipated to be potential computer glitches and potential supply disruptions as a result. That didn’t end up happening but we realized the need for an FDA shortage program. We formed an initial Drug Shortage Staff and developed policies and procedures to work with manufacturers to prevent and mitigate shortages. Shortages continued to occur and unfortunately reached a high point in 2011 when there were 251 shortages, including oncology drugs, anesthetic agents, emergency drugs and antibiotics. Since that time, shortages have declined due in part to new legislation enacted in 2012, however critical shortages have continued to occur.

Since the beginning of FDA’s Drug Shortage program in 1999, we have continued to see the majority of shortages involving older sterile injectable drugs. Most of these shortages are caused by quality problems. These quality problems include defects that occurred in the drug during manufacturing or a problem at the manufacturing site such as a line breaking down or a sterility breach. Multiple drugs are made on the same production lines for these older products and capacity is limited. Also these older generic drugs are often discontinued for business reasons since they can be less profitable than newer drugs for manufacturers and this leaves few manufacturers remaining. When there is a manufacturing slowdown or shutdown for quality or other reasons, there is often not another firm able to make up the shortfall. Chemotherapy drugs have gone into shortage for these reasons and we see this lack of available manufacturing capacity as well as breakdowns in quality to be ongoing problems for this class of drugs.

FDA has made mitigation and prevention of shortages a top priority and whenever we are notified of a potential shortage from manufacturers, we do all we can, using the tools we have available to try to prevent the shortage whenever possible. Our first step with either an actual or potential shortage is working with the manufacturer on anything they need to address or prevent the shortage. For example, if there is a quality problem with the drug, FDA has a network of experts including chemists, microbiologists, and manufacturing experts to assist the firm in addressing the problem. Our Drug Shortage staff coordinates this effort. An example of such situation is the shortage of cytarabine several years ago when a quality issue involving crystallization of the drug in the vials was occurring. The firms were able to provide data to show warming the vials slightly would dissolve the crystals with no impact to the efficacy of the drug. A Dear Healthcare Professional letter was able to be shipped by the manufacturer with the affected vials notifying oncology pharmacists and nurses to warm the vials slightly so that they could be used safely. The firms were able to correct the problem for the next batches through a manufacturing change. Another step we take in any shortage situation is to expedite review of any applications or of any changes a firm needs to make to address or prevent the shortage. Examples include new manufacturing lines, new sites, as well as additional raw material suppliers which may be needed. Finally, when there is not an FDA approved manufacturer willing or able to increase production to prevent or mitigate the shortage, FDA searches for an overseas manufacturer willing and able to temporarily import the drug to meet patient needs during the shortage. FDA evaluates the overseas manufacturing site and the product itself to ensure there are no risks for US patients. A Dear Healthcare Professional letter is shipped with the drug and posted on our website highlighting any significant differences in the overseas product that practitioners need to be aware of. This has been done for multiple oncology drugs in the past including methotrexate injection and doxorubicin liposomal injection. FDA also encourages the company temporarily importing the drug to obtain FDA approval for the overseas version since having additional approved sources of critical oncology drugs will help prevent future shortages.

In 2012, the Food and Drug Administration Safety and Innovation Act was signed into law which gave FDA additional authority for drug shortages. This legislation requires manufacturers to notify FDA as soon as they are aware of any potential supply disruption. Before this law, manufacturers did not routinely notify FDA of potential or actual shortages and unfortunately we were finding out about shortages from hospitals, when they could no longer order the drug. By that time patients were already being impacted and by having this notification requirement, FDA often has additional time to utilize the tools we have available to work with manufacturers to mitigate and sometimes even prevent shortages. FDA was able to prevent 160 shortages through early notification from manufacturers in 2018 and we continue to encourage companies to notify us as early as possible so we can continue these efforts.

FDA maintains a database on our website of all current shortages as well as discontinuations and resolved shortages and clinical providers are encouraged to check the website to see if a product they are having difficulty obtaining is listed. Here is the website link: https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm [accessdata.fda.gov]. If the drug isn’t listed, providers can email our Drug Shortage Staff at This email address is being protected from spambots. You need JavaScript enabled to view it. and we will send any information we have on the supplies and how to obtain the drug. FDA realizes the devastating impact on patients and their families that shortages have and will continue to do all we can to help keep vital drugs available for patients. However, we realize that especially for the older sterile injectable drugs, including chemotherapy drugs, that have continued to go into shortage, more needs to be done. To further understand and address shortages, in July 2018, FDA created an inter-agency Task Force, in response to a request from 31 Senators and 104 US congressional representatives. This task force is comprised of senior leaders from FDA, the Centers for Medicare and Medicaid and Medicaid Services, and the Department of Veterans Affairs to identify the root causes and holistic solutions for this critical public health problem. This Task Force received stakeholder input from a public meeting, a docket for comments, and multiple listening sessions and published a report based on all findings which is publicly available on FDA’s website. This report focuses on the broad economic issues that lead to shortages and lays out potential solutions for this problem. In addition to sharing the findings on potential solutions in the report, we are also working on additional guidance to industry, including encouraging companies to have risk management plans in place. Having these plans would help ensure manufacturers have contingency and back up plans in the case of a quality failure or a manufacturing line shutdown so that shortages can be more easily prevented or minimized.

Unfortunately we continue to see the older sterile injectable drugs go into shortage and there is a lack of incentives for firms to continue to make these drugs or to have backup plans or redundancy in place to prevent shortages. We know that the problem isn’t lessening and although FDA continues to do all we can, the broader economic issues need to be explored to encourage companies to ensure continued quality and supply of critical drugs for the patients that depend on them.