Frequently Asked Questions About the Drug Shortages Program
- How many drug shortages were there in 2010, 2011, and 2012? And do we expect less, as many, or more shortages in the future?
- What is the major reason for these shortages?
- What can FDA do to address drug shortages?
- How does FDA communicate to the public about drug shortages?
- Are companies required to notify FDA of a potential drug shortage?
- When FDA takes an action such as sending a warning letter to a company or takes an enforcement action, is the shortage impact considered beforehand?
- How does FDA address shortages of medically necessary drugs that have not received FDA approval?
- Have FDA standards changed and companies can no longer meet those standards?
- Why are there so many quality problems with drugs occurring recently?
- What is the CDER Drug Shortage Staff (DSS)?
- Who handles drug shortage issues in CDER?
- Who handles non-CDER drug shortages?
- Why aren’t all drugs in short supply listed on the Drug Shortage web page?
- How does the CDER Drug Shortage Program find out about shortages?
- How does the CDER Drug Shortage Program verify that a shortage exists?
- Can FDA do anything about pricing of medications?
- Where can I obtain additional information on drug shortages?
- Is the drug product information listed on the FDA’s Drug Shortage website the same as on the American Society of Health-System Pharmacists (ASHP) Drug Shortage website?
A: In 2010, there were 178 drug shortages reported to the U.S. Food and Drug Administration (FDA), 132 of which involved sterile injectable drugs. In 2011, there were 251 drug shortages reported, 183 of which involved sterile injectable drugs. In 2012, there were 117 new drug shortages, 84 of which involved sterile injectable drugs. Although in 2012, there were fewer reported drug shortages. FDA continues to see shortages involving older sterile injectable drugs. These shortages have involved cancer drugs, anesthetics used for patients undergoing surgery, as well as drugs needed for emergency medicine, and electrolytes needed for patients on IV feeding.
Fortunately, FDA has also been able to prevent a significant number of drug shortages. In 2011, FDA was able to help prevent 195 drug shortages. And in 2012, we have been able to prevent 282 drug shortages. The Agency’s ability to prevent shortages has been greatly facilitated by increased early notifications from manufacturers.
A: A major reason for these shortages has been quality/manufacturing issues. However there have been other reasons such as production delays at the manufacturer and delays companies have experienced receiving raw materials and components from suppliers. Discontinuations are another factor contributing to shortages. FDA can't require a firm to keep making a drug it wants to discontinue. Sometimes these older drugs are discontinued by companies in favor of newer, more profitable drugs.
With fewer firms making older sterile injectable drugs, there are a limited number of production lines that can make these drugs. The raw material suppliers the firms use are also limited in the amount they can make due to capacity issues at their facilities. This small number of manufacturers and limited production capacity for older sterile injectables, combined with the long lead times and complexity of the manufacturing process for injectable drugs, results in these drugs being vulnerable to shortage. When one company has a problem or discontinues, it is difficult for the remaining firms to increase production quickly and a shortage occurs.
A: 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.
For manufacturing/quality problems, FDA works with the firm to address the issues. Problems may involve very low risk (e.g. wrong expiration date on package) to high risk (particulate in product or sterility issues). Regulatory discretion may be employed to address shortages to mitigate any significant risk to patients.
FDA also works with other firms making the drugs that are in shortage to help them ramp up production if they are willing to do so. Often they need new production lines approved or need new raw material sources approved to help increase supplies. FDA can and does expedite review of these to help resolve shortages of medically necessary drugs. FDA can't require the other firms to increase production.
When a shortage occurs and a firm has inventory that is close to expiry or already expired, if the company has data to support extension of the expiration dating for that inventory, FDA is able to review this and approve the extended dating to help increase supplies until new production is available.
When the US manufacturers are not able to resolve a shortage immediately and the shortage involves a critical drug needed for US patients, FDA may look for a firm that is willing and 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. These criteria include the formulation and other attributes of the drug as well as the quality of the manufacturing site where the drug is made.
FDA works to find ways to mitigate drugs shortages; however, there are a number of factors that can cause or contribute to drugs shortages that are outside of the control of FDA.
Also, FDA issued a long-term strategic plan to outline the agency’s priority actions, as well as actions drug manufacturers and others can take, to prevent drug shortages by promoting and sustaining quality manufacturing.
Below is a link for full information on the Strategic Plan
A: 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.
FDA works to communicate information about shortages on the FDA website, based on information provided by the manufacturers. FDA appreciates all information that manufacturers provide for posting on the FDA website since we realize how necessary this is for patients and healthcare professionals to be informed when shortages occur and how long they may last. Manufacturers can report any information for posting to email@example.com.
A: Manufacturers are required to report information about shortages to FDA, and are required to report the reasons for shortages and the expected duration of shortages on the FDA website. Title X of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, signed on July 9th, list the mandatory reporting requirements for manufacturers.
FDASIA provides FDA with important new authorities that will help the Agency to further combat drug shortages. Some of the enhanced authorities are as follows:
- 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.
Below is a link for full information on the FDASIA
Below is a link to a fact sheet highlighting Title X of the FDASIA
Fact Sheet: Drug Products in Shortage in the United States
A: FDA is responsible for ensuring that safe, effective drugs are available for US patients. When there are severe quality issues identified that could result in harm to patients, there may not be a way to avoid a shortage. However, FDA does everything possible to work with firms to address any potential risks to keep medically necessary products available while also ensuring there is not going to be harm to patients associated with the quality issues.
A: FDA is aware that there are drugs being marketed that have not received FDA approval but are medically necessary and have been marketed for many years. When shortages occur for these drugs, FDA addresses these shortages through our normal processes and works with the companies to ensure patient needs are being met while also ensuring there is not any significant risk associated with the drug due to quality, safety, or efficacy that could result in harm to patients. FDA encourages the companies making these drugs to notify us of any changes in supply and also encourages the firms to seek FDA approval to help ensure ongoing quality and safety of these drugs for US patients.
A: FDA standards have not changed recently. The companies are responsible for ensuring that the drugs they make are manufactured in quality manufacturing sites so that US patients are not put at risk.
A: Problems can and do occur at any point in the manufacturing process and the manufacturing of sterile injectables is particularly complex and involves many steps where things can go wrong. When problems occur at any step in the process, FDA encourages firms to notify FDA of any potential supply issues so we can help address the problem. 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.
A. This program, within the Center for Drug Evaluation and Research (CDER), was established to address potential or actual shortages of drugs that have a significant impact on public health. Through communication, facilitation and negotiation, DSS works with pharmaceutical manufacturers, review divisions, compliance and other components of FDA to manage product shortages.
A: FDA's Drug Shortage Staff (DSS) resides in the Center for Drug Evaluation & Research (CDER). It consists of a dedicated staff of 11 scientific and regulatory experts who are responsible for the coordination of all activities related to the prevention and mitigation of drug shortages. As the number of reports of drug shortages has increased, this staff has grown from 3 professionals to 11 in the past few years.
The DSS coordinates with a host of other experts in CDER, which is estimated to utilize a total of about 25 full time employees, currently. Among other activities, the experienced and capable staff conduct medical necessity assessments, consider appropriate action on inspection reports and assess proposals of firms as they attempt to avoid supply disruption or increase production. They reside in many Offices across CDER, including the Office of Compliance, Office of Generic Drugs, Office of Pharmaceutical Sciences and the Office of New Drugs.
We expect that reports of potential and actual drug shortages will continue to increase in the next months to years, requiring that FDA allocate more resources to mitigate drug shortages in a timely manner to protect public health. In doing so we will continue to focus on assuring a multifaceted approach, including close collaboration of all stakeholders within and outside of the Agency, including industry, regulators, payers, Congress, and others.
- Center for Biologics Evaluation and Research (CBER)
Biological products, including blood and vaccines
Website: Biological Product Shortages
E-mail address for reporting shortages: CBERshortages@fda.hhs.gov. Also, biological product manufacturers and healthcare personnel may report a real or suspected biological product shortage by calling 240-402-8380. .
- Center for Food Safety and Nutrition (CFSAN)
Food, including medical foods and cosmetic products
Center for Food Safety and Nutrition (CFSAN) Website – 1-888-SAFEFOOD
- Center for Veterinary Medicine (CVM)
Food additives and drugs that will be given to animals
- Center for Devices and Radiological Health (CDRH)
Medical devices and radiation-emitting products
firstname.lastname@example.org – 1-800-638-2041
A. The CDER Drug Shortage Program focuses on shortages of medically necessary products since these shortages have the greatest impact on public health. The Drug Shortage page on the FDA website lists shortages primarily of medically necessary products. Shortages that are expected to be resolved quickly or which involve only a particular strength or package size, which has a substitute strength(s) and package size(s), are not usually the focuses of the DSS.
A. Manufacturers are required to report shortages to FDA as stated in FDASIA. We believe this new authority will prove helpful, resulting in additional notifications that will help prevent additional shortages. Other components within FDA may also provide such notification. In addition, the DSS also gets reports from healthcare professionals, patients/individuals, or professional organizations using the electronic mail account (email@example.com).
A. The CDER Drug Shortage team utilizes information from manufacturers, distributors and market share data to determine if a shortage exists. (DSS defines a drug shortage as follows::
The total supply of all versions of the approved product available at the user level will not meet the current demand. A registered alternative manufacturer will not meet the current and/or projected demands for the potentially medically necessary use(s) at the user level.)
A. Pricing issues are not within the purview of FDA.
However, if you have concerns regarding the price of your medications, you may wish to contact the Federal Trade Commission (FTC). The FTC enforces a variety of federal antitrust and consumer protection laws. The FTC seeks to ensure that the nation’s markets function competitively, and are vigorous, efficient, and free of undue restrictions. Contact information for the FTC is as follows:
Federal Trade Commission
Bureau of Competition
Office of Policy and Evaluation
Washington, D.C. 20580
Phone: (202) 326-3300
Website address: http://www.ftc.gov
When shortages occur, there are often faxed and e-mailed advertisements received by pharmacies from unknown distributors that offer these drugs at higher prices than the pharmacy normally pays. Concerns should be reported to FDA via the Office of Criminal Investigations at the following link: http://www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm
A. The American Society of Health System Pharmacists (ASHP) lists drug shortages and additional information.
A. Both FDA and ASHP sites provide drug shortage information, however, there are some differences. FDA receives information provided by manufacturers regarding their ability to supply the market as well as market sales data and a product is listed on FDA’s Drug Shortage website once it has been confirmed with information provided by manufacturers and market sales research that overall market demand is not being met by the manufacturers of the product. FDA does not consider a product to be in shortage if one or more manufacturers are able to supply the full market demand for the product. In contrast, ASHP’s Drug Shortage website provides information about which manufacturers have the drug available and which ones do not, since supply chain disruptions may occur when all previous manufacturers are not yet back on the market with all formulations and all dosage sizes, even if the full market demand is being met by the current manufacturers per the information FDA is receiving.Regardless of these differences, FDA and ASHP will continue working closely to share information and provide the most updated information possible on our websites. Please refer to this chart for more information: Contrasting the FDA (CDER) and ASHP Drug Shortage Websites: What are the differences?.