What Does the FDA Have to Say About Drug Shortages?

Q. What is the major reason for these shortages?

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.

Q. What can FDA do to address drug shortages?

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.

Q. How does FDA communicate to the public about drug shortages?

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 todrugshortages@fda.hhs.gov.

Q. Where can I obtain additional information on drug shortages?

A. The American Society of Health System Pharmacists (ASHP) lists drug shortages and additional information.

To read more FAQs about drug shortages from the FDA visit http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050796.htm