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U.S. Department of Health and Human Services

Drugs

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Podcast: Drug Shortages

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In the last few years, there has been an increasing amount of drug shortages.  These shortages have the potential to impact patient care.  Hi, I’m Yolanda Fultz-Morris from the Food and Drug Administration. 

Today, I will be speaking with Valerie Jensen, Associate Director of Drug Shortages, at FDA’s Center for Drug Evaluation and Research, to explain what FDA is doing to prevent and lessen drug shortages.

The Drug Shortages Program, within the FDA’s Center for Drug Evaluation and Research, was established to address potential or actual shortages of prescription, over-the-counter, or generic drugs that have a significant impact on public health.  Through communication, facilitation and negotiation, this program works with pharmaceutical manufacturers, review divisions, compliance and other components of FDA to manage product shortages.

Capt. Jensen, how many drug shortages were there in 2010? And do we expect less, as many or more shortages in 2011?

A: In 2010, there were 178 drug shortages reported to the U.S. Food and Drug Administration, 132 of which involved sterile injectable drugs. In 2011, FDA has continued to see an increasing number of shortages, especially those 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.

What is the major reason for these shortages?

A: A major reason for these shortages has been manufacturing issues involving product quality. Other reasons include production delays at the manufacturer, and delays in receiving raw materials and components from suppliers. Discontinuations are another factor -- sometimes older drugs are replaced by newer, more profitable drugs. FDA can't require a firm to keep making a drug it wants to discontinue. 

With fewer firms making older sterile injectable drugs, there are a limited number of production lines. The small number of manufacturers, limited production capacity for older sterile injectables, long lead times, and complexity of the manufacturing process, 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 often occurs.

What does FDA do to address drug shortages?

A: For manufacturing problems, including quality issues, FDA works with the firm to determine the severity of the problem. For example, problems may involve very low risk, such as a wrong expiration date on the package. High risk problems can be particulates in the product or sterility issues. Regulatory discretion may be employed to address these shortages.

FDA works with the other firms that make the drugs in short supply to determine if they are willing to ramp up their production. Often they need new production lines approved or need new raw material sources approved. FDA can and does expedite review of these to help resolve shortages of medically necessary drugs. However, FDA can't require these other firms to increase production.

When a shortage occurs and a firm has inventory that is close to expiry or has 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 U.S. manufacturers are not able to resolve a shortage immediately and the shortage involves a critical drug needed for U.S. patients, FDA finds foreign companies that are willing and able to import the drug during the shortage. FDA evaluates the foreign drug for quality and to ensure that it does not pose significant risks. Information about the imported drug, and how patients can access supplies, is posted on FDA’s Drug Shortage website along with the Dear Healthcare Professional letter from the company that is importing the drug. FDA does not always find a firm willing and able to import a drug during a shortage, however it is something we explore.

How does FDA tell the public about drug shortages?

A: FDA communicates information about shortages received from the manufacturers.  Companies voluntarily provide the shortage information that is posted on the FDA website.  Manufacturers are not required to report information about shortages to FDA, and are not required to report the reasons for shortages or the expected duration of shortages on the FDA website. FDA appreciates all information that manufacturers provide for posting on the FDA website. Manufacturers can report any information for posting to drugshortages@fda.hhs.gov.

Are companies required to notify FDA of a potential drug shortage?

A: No, but FDA encourages companies to provide notifications about any issues that could lead to a shortage. Current regulations do not require that companies notify FDA of shortages. The only requirement under current regulations is that companies inform FDA six months in advance for discontinuations of sole source, medically necessary drugs. There is not a penalty if firms do not notify FDA of these discontinuations. In 2010, there were 38 shortages prevented due to companies notifying FDA voluntarily of potential issues. FDA was able to work with the companies to avoid a shortage.

When FDA takes an action against a company, is the shortage impact considered?

A:  FDA is responsible for ensuring that safe, effective drugs are available for U.S. patients.  When severe quality issues are identified there may not be a way to avoid a shortage. FDA does everything possible to work with firms to address any potential risks to keep medically necessary products available while ensuring there is not going to be harm to patients associated with any quality issues.

How does FDA address shortages of medically necessary drugs that have not received FDA approval?

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. FDA also ensures there is no significant risk associated with the drug due to quality, safety, or efficacy. FDA encourages companies making these drugs to notify us of any changes in supply and encourages firms to seek FDA approval to help ensure ongoing quality and safety of these drugs.

Have FDA standards changed and companies can no longer meet those standards?

A:  FDA standards have not changed recently. Companies are responsible for ensuring that the drugs they make are manufactured in quality manufacturing sites. 

Why are there so many quality problems with drugs occurring recently?

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. 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. Companies are not required to notify FDA of potential supply issues; however, we encourage them to report any potential shortages to FDA at drugshortages@fda.hhs.gov so that we can help address the problem.

Thank you, Captain Jensen for answering questions about FDA’s Drug Shortages Program. For more information on FDA’s Drug Shortages Program, visit www.fda.gov and search drug shortages.