FDA actions reduce drug shortages but critical issues remain
By CAPT Valerie Jensen
At FDA, we understand that health care professionals who care for patients using drug therapies need the right drug for the right patient at the right time. We’re working hard to help enable this important tenet of health care for your patients. For instance, over the past year, we’ve seen a 60 percent decrease in new drug shortages. However, more work needs to be done. This year several critical shortages were added to the list of drugs in short supply. These include intravenous (IV) saline bags and
Preventing and mitigating drug shortages continues to be a top priority for FDA, and we are using every tool in our toolbox to forge solutions.
Prevention of shortages, as opposed to resolving shortages that arise, is, of course, the ideal solution: There were 44 new drug shortages in 2013, down from 117 in 2012. Two key prevention strategies have helped drive this significant decrease in shortages, 1) early notification, and 2) a focus on manufacturing quality.
New notification requirements from the Food and Drug Administration Safety and Innovation Act
help ensure that manufacturers inform FDA in advance of potential supply disruptions. This law has enabled FDA more time to work with manufacturers, and has helped tremendously, in many cases, to prevent shortages. However, we cannot prevent all shortages via early notification. For example, in the cases of I.V. saline bags and nitroglycerin, FDA was notified ahead of time by manufacturers of the potential for shortages, but the shortages were not able to be avoided. Alternate manufacturers could not increase production. Unfortunately, with sterile injectables this is not an uncommon situation since there are a limited number of manufacturing lines and facilities able to make these drugs and when problems arise, it is often the case that other drug makers have no additional manufacturing capacity.
A Focus on Manufacturing Quality
We are working with stakeholders on another important area of prevention: promoting and sustaining sound manufacturing quality. The majority of drug shortages continue to result from quality or other major manufacturing problems. This is especially important in the area of generic sterile injectable drugs, a category of product critically important for public health, but strongly affected by shortage related manufacturing issues stemming from poor manufacturing quality.
Ultimately, manufacturers are responsible for ensuring sustainable production of quality drugs.
Strategies to Mitigate Ongoing Shortages
FDA has been working to address ongoing shortages that have been unresolved over the past several years. There were 97 ongoing shortages at the end of 2013. Many of these dated back to 2011 and 2012. Again, the majority of these shortages were due to manufacturing quality problems that led to shutdowns at the facilities where these drugs were made. In many cases, these drugs in short supply are made from only one or very few manufacturers.
Encouraging More Suppliers
FDA continues to encourage pharmaceutical companies interested in making drugs in short supply to submit applications so that there are multiple manufacturers making these drugs. Spreading the production of a drug over a variety of manufacturers reduces the potential for an over reliance on one or few manufacturers. It also limits the impact on shortages if any particular manufacturer has a production issue that can result in a plant shut down and no available product from that facility.
Expediting Review of New Applications for Drugs in Short Supply
FDA is pleased to note that there have been several recent examples of companies submitting applications for older drugs which have been in ongoing shortage. It is the policy of FDA to expedite review of drugs that are in shortage or at risk of shortage and these applications were expedited by FDA’s Office of Generic Drugs. For example, the drug maker, Innopharm received approval for acetylcysteine injection, Emcure received approval for amikacin and prochlorperazine injectables, Heritage for tetracycline capsules and cidofovir, and BD Rx received approval for metoclopramide injection. All of these drugs are older drugs and many have had ongoing shortage issues. Having these drugs available from additional manufacturers should to help prevent new shortages in the future.
FDA has also had ongoing discussions with manufacturers that are already making drugs in shortage to find out if they are able to devote additional capacity to meet shortfalls to resolve a shortage. Manufacturers are working closely with FDA on these efforts and there are many examples of successes. For example, Sagent and Hospira were able to increase production on atracurium, and Reckitt Benckiser and Hospira were able to meet demand for buprenorphine injection. In addition to expediting new applications, FDA also expedites review of any manufacturing changes that are needed for companies to increase production to respond to shortages and continues to work with manufacturers on these efforts.
FDA applauds the efforts of companies to seek approval of drugs that have been in shortage and also is glad to see companies increasing production of drugs in shortage. FDA is continuing to explore, along with industry and other stakeholders, possible additional incentives for addressing ongoing shortages. FDA published a strategic plan
which outlines these plans in detail.
We are not out of the woods yet with shortages and we are facing new critical shortages which are continuing to impact patients in 2014. FDA considers drug shortages to be a critical public health issue and we continue to work with industry and other stakeholders on addressing the root causes of shortages, as well as working to do everything possible to prevent shortages from occurring.
Our Strategic Plan for Preventing and Mitigating Drug Shortages
outlines ways to improve our communication with stakeholders. One example of our enhanced communications is the launch of a new searchable format for the FDA Drug Shortage website. This enhanced feature is expected to help health care professionals quickly identify drugs in shortage and find information on availability. Additionally, the FDA website now provides:
- sections for new and updated drug shortages
- a listing of drug shortages by therapeutic categories
- ability to report a shortage via a web form
- sorting functions for drug shortages by generic name or status
We developed this update based on feedback from a variety of stakeholders, including health care professionals.
We will continue to improve our communication tools to assist health care professionals with information they need to provide care to their patients.
Valerie Jensen is the associate director of CDER’s Drug Shortage Program
 Reference Woodcock and Wosinska