This FDA Expert Commentary was recorded on September 20, 2011, prior to the October 31st executive order from the President directing the FDA to broaden reporting of potential shortages of certain prescription drugs and to further expedite regulatory reviews that can help prevent or respond to shortages.
Hello. I am Commander Jouhayna Saliba, Senior Regulatory Program Manager for the US Food and Drug Administration (FDA) Drug Shortage Program in the Center for Drug Evaluation and Research. I am pleased to be here today as part of the FDA's Expert Commentary Series on Medscape to talk about FDA's response to the ongoing problem of drug shortages. Our program's mission is to address potential or actual drug shortages that have a significant impact on public health.
Drug shortages in the United States have been on the rise. The FDA recognizes the significant public health consequences that can result from drug shortages and makes tremendous efforts within its legal authority to address and prevent drug shortages.
The drugs in shortage are constantly changing, but in general the main types of drugs that have been in shortage have involved cancer drugs, anesthetics used for patients undergoing surgery, sterile injectable drugs, electrolytes used for patients needing intravenous nutrition therapy, and other medically necessary sterile drugs.
FDA initiated the Drug Shortages Program in 1999 and has been tracking numbers of shortages annually since 2005. During this time period, we have noted a steady increase in shortages. In 2010, there was a record number of shortages, and in 2011 FDA has continued to see an increasing number of shortages, especially those involving older sterile injectable drugs.
There are a number of different factors contributing to the current shortage of sterile injectables and other drugs, including manufacturing issues and economic factors. Some companies have decided to discontinue making their products for business reasons, others have had problems with their raw-material suppliers, and some have experienced manufacturing deficiencies that compromise the safety and efficacy of their products.
In 2010, a majority of the drugs in shortage had quality and manufacturing problems. Some of these quality problems included the presence of particulates, microbial contamination, and newly identified impurities in sterile injectables. Companies sometimes voluntarily stop production or suspend production of critical drugs when manufacturing problems occur so that they can resolve the root cause of product-quality problems. Some of these issues are complex, and companies may need to take substantial amounts of time to correct the underlying cause of the problem.
When a company identifies a quality problem, it will often try to address the problem while still continuing to manufacture the product. FDA works closely with companies to ensure that appropriate corrective actions are implemented in a timely manner, without interrupting the supply of medically necessary drug products, while also ensuring that the products produced are safe and effective. However, there are times when a company decides that it must recall or stop manufacturing a product. FDA works with the company to address the issues. Problems may be very low risk (eg, wrong expiration date on package) to high risk (particulate in product or sterility issues). FDA will look at the risk-benefit balance on a case-by-case basis in order to be flexible in addressing shortages and to mitigate any risk to patients.
FDA also works with other companies 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 or 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. However, FDA can't require the other companies to increase production.
When a shortage occurs and a company has inventory that is close to expiry or already expired, extension of the expiration dating for that inventory can be considered if the company has data to support that extension. In those situations, FDA is able to review this data 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 searches for overseas companies that are willing and able to import the drug until the shortage is resolved. FDA evaluates the overseas drug to ensure that it is of adequate quality and that the drug does not pose significant risks for US patients. The information about the imported drug and how patients can access supplies is posted on the FDA Drug Shortage website along with the Dear Healthcare Professional letter from the company that is importing the drug. FDA cannot always find a company willing and able to import a drug during a shortage; however, it is something we explore when there is a critical shortage and US patient needs are not being met.
FDA works to find ways to mitigate drug shortages; however, there are a number of factors that can cause or contribute to drugs shortages that are outside of the control of FDA. It's important to note that not all shortages can be prevented. Natural disasters, severe quality defects, or unforeseen manufacturing shutdowns are examples of situations where a shortage may not be able to be prevented.
FDA works to communicate information about shortages based on information provided by the manufacturers and learned through reports from health care professionals. Companies voluntarily provide the shortage information posted on the FDA website. They are required to report shortages of sole source, medically necessary drugs, but there are no penalties for failure to report. Manufacturers are not required to report information about disruptions in drug supplies to FDA, and are not required to always report the reasons for disruptions or the expected duration of shortages on the FDA website.
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 companies to notify FDA of any potential supply issues so we can help address the problem.
We acknowledge that a shortage of a patient's medicine can be a frightening prospect, especially if the medicine is critical to their health and there are no alternatives available. The Agency remains committed to working on this very important and critical public health issue. FDA will do all it can within our current authority to help minimize drug shortages that have significant impact on public health.