Frequently Asked Questions about Drug Shortages (2024)

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 where the manufacturer reports a potential or actual shortage to FDA, FDA works with the firm to address the shortage. Problems can vary in significance, such as relatively low risk problems (e.g., minor error on the label) to high risk (e.g., particulate in product, sterility issues). Regulatory discretion may be employed for a drug to be distributed to address shortages after additional controls are implemented to mitigate significant risk to patients as needed.

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.

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Frequently Asked Questions about Drug Shortages (2024)

FAQs

What is the most common reason for drug shortages? ›

Manufacturing quality issues are the major reason for drug shortages. 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.

What is a major contributor to US drug shortages? ›

The big picture: Drug shortages have multiple causes, including factors like increased demand, natural disasters disrupting production and manufacturing quality issues.

How can medication shortages be prevented? ›

The key to preventing drug shortages might be to find manufacturers of high-quality products and pay them enough for their drugs so that they make a reasonable profit and can invest in their facilities when they need to.

How long is a drug shortage going to last? ›

It also found that while the average drug shortage lasts about 1.5 years, more than 15 critical drug products have been in shortage for over a decade. Many Americans became aware of national shortages during the Covid-19 pandemic.

What are the three main causes of shortage? ›

Key Takeaways

A shortage occurs when the quantity demanded is greater than the quantity supplied at the market price. There are three main causes of shortage—increase in demand, decrease in supply, and government intervention.

What are the problems with drug shortages? ›

We found that drug shortages were predominantly reported to have adverse economic, clinical and humanistic outcomes to patients. Patients were more commonly reported to have increased out of pocket costs, rates of drug errors, adverse events, mortality, and complaints during times of shortage.

Why are there drug shortages in 2024? ›

The shortage began in late 2022 initially due to a delay from a manufacturer. As of early 2024, the shortage is now demand-driven, according to the U.S. Food and Drug Administration.

How do drug shortages impact patients? ›

Lack of available treatments for emergent medical conditions and poisoning negatively impact drug therapy in a variety of ways. Shortages compromise or delay medical care, result in medication errors, and increase patient mortality and morbidity [1, 2].

Is there a drug shortage in 2024? ›

Drug shortages have reached a record high in the first three months of 2024. In the first quarter of the year, 323 drugs were running low, surpassing the 2014 high of 320, according to data provided by the American Society of Health-System Pharmacists (ASHP) and the University of Utah Drug Information Service.

What is the best solution to the shortage of medicine? ›

The six key actions to implement the medicine shortage-reducing strategies are: (1) initiate a biannual forum for hospitals and industry; (2) establish a medicines substitutes information service operating nationally; (3) share information on likely changes to hospital usage; (4) reform stock allocation strategies; (5) ...

How to solve America's drug shortage problem? ›

Encourage New Manufacturers and New Manufacturing Sites

Entering the market to manufacture a generic drug is a multi-year process that requires investment in scientific, manufacturing, and regulatory functions. This makes it difficult for new manufacturers to enter the market and increase supply when shortages occur.

What drugs are we running out of? ›

Current Drug Shortages
Generic NameRevision Date
Amoxicillin Oral PresentationsMarch 17, 2024
Amphetamine Extended-Release Oral PresentationsMarch 30, 2024
Amphetamine Mixed Salts, Immediate-Release TabletsMarch 10, 2022
Amphetamine Mixed Salts, Immediate-Release TabletsMarch 30, 2024
239 more rows

How many drug shortages are there in the US? ›

That's according to the American Society of Health-System Pharmacists (ASHP), which has released new data showing there were 323 drugs in shortage in the U.S. as of 2024's first quarter—the highest number recorded since ASHP began tracking shortage data back in 2001.

How much does a drug shortage cost? ›

An analysis published in 2019 estimated that drug shortages result in at least $359 million annually in additional labor costs to hospitals. This comes on top of the estimated $200 million annually that hospitals and health systems spend paying higher prices to acquire alternative therapies.

What is causing so many shortages? ›

The pandemic, the labor shortage, and changes in demand are causing cascading supply chain issues leading to shortages of goods from cars to chicken wings.

What drugs are in shortage right now? ›

Current Drug Shortages
Generic NameRevision Date
Albuterol sulfate and Ipratropium Bromide Inhalation SolutionMarch 30, 2024
Albuterol Sulfate Metered Dose InhalersDecember 15, 2021
Alfentanil InjectionFebruary 22, 2023
Alfuzosin Extended-Release TabletsMarch 11, 2024
239 more rows

Why are there so many product shortages? ›

While the supply chain shortages started with COVID, they're also due to increased consumer demand, which was fueled by the federal stimulus checks that we probably didn't need to keep the economy recovering. We just didn't understand how consumer demand was going to shift, once the pandemic began to ease.

Why is there a shortage of ADHD medication? ›

The ongoing shortage, entering its second year, stems from several problems: a growing demand for the medications (including a rise in adults seeking treatment for ADHD), supply chain issues, telehealth trends and Drug Enforcement Administration (DEA) regulations on production of controlled stimulants.

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