Ask two trusted sources how bad America's drug shortage problem is, and you get two answers that seem to come from different countries.
By the Food and Drug Administration's count, 2024 was the calmest year in more than a decade. The FDA's drug center recorded just 15 new shortages that year. That is down from a peak of 251 in 2011, and it is the lowest total in ten years.
But by the count that hospital pharmacists watch most closely, 2024 was the worst year on record.
ASHP and the University of Utah tracked 323 active shortages in the first three months of the year. That is the highest number since the two groups started counting in 2001.
Both numbers are correct. The gap between them is the real story.
The country has gotten better at stopping new shortages before they hit. It has gotten worse at ending the ones already underway. A problem that used to come in sudden waves has turned into a long-term condition.
Below, Kivo, a quality management system and RegOps platform for life sciences teams, looks at how America's drug shortages became fewer but longer-lasting, and which medicines keep running short.
New Shortages vs Active Shortages
The FDA tracks new shortages, and only for a set list of drugs that patients truly need. It marks a shortage as over once supply catches up to demand across the country. Under that definition, new shortages have fallen steadily.
The drop began in 2012, when Congress started requiring drugmakers to warn the FDA early about manufacturing problems. The FDA reported 49 new shortages in 2022, 55 in 2023, and 15 in 2024. The agency also says it quietly prevented 283 shortages in 2024 by working with drugmakers before supply ran out. That is up from 222 in 2022.
ASHP casts a much wider net. It counts every drug that is short from a pharmacist's point of view. That includes products the FDA does not track. It also includes local or regional gaps that never grow into a national shortage.
This is why the pharmacist count runs so much higher. ASHP found 323 active shortages at the 2024 peak. The FDA counted 113 ongoing shortages at the end of that same year.
Neither number is a trick. One measures how often a new fire starts. The other measures how many fires are still burning. Put together, they describe a system that has learned to prevent fires while still struggling to put any out.
Which Drugs Have The Worst Shortages?
The drugs at the center of the problem are rarely the ones patients see in ads. They are the cheap, hard-to-make basics that hospitals cannot work without.
Sterile injectable drugs top the list, and they have for years. These are drugs given through an IV or a syringe. About half of the shortages ASHP recorded in 2024 were injectable products. They are hard to make, they need special sterile factories, and they often come from only one or two suppliers. So a single problem at one plant can ripple across the whole country.
Sorted by type, the top of the 2024 shortage list included central nervous system drugs, antibiotics, hormone drugs, chemotherapy drugs, and IV fluids. Cancer care sits right in that mix. Generic injectable chemotherapy drugs and the emergency medicines kept on hospital crash carts have been among the most stubborn and worrying gaps, according to ASHP. Controlled substances make up a real share too, about 15% of active shortages in recent quarters. That pulls the Drug Enforcement Administration into the picture alongside the FDA.
The Number That Explains The Story
Counting shortages tells you how many drugs are scarce right now. It misses the change that has really reshaped the problem. Shortages now last far longer than they used to.
About half of the active shortages ASHP tracked in 2024 had already lasted two years or more. A Senate committee found that the average shortage runs about a year and a half. At least 15 critical drugs have been short for more than a decade. Some long-running shortages have started to ease lately. Even so, the backlog stays heavy. In one recent count, more than three out of four active shortages had started in 2022 or later.
That length is what turns a short-term blip into a lasting health problem. A drug that is scarce for three weeks is a headache a hospital can plan around. A drug that is scarce for three years forces permanent workarounds. Staff have to switch patients to backup drugs that may work less well. They have to make hard choices about who gets a limited supply. And pharmacists end up spending their days hunting for substitutes instead of caring for patients.
Why Why Shortages Are Lasting Longer
Drugmakers rarely explain themselves. When the University of Utah looked at the causes behind 2023 shortages, 60% were listed as unknown, or the maker simply would not say.
Of the reasons that were given, three came up most:
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Supply-and-demand problems
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Manufacturing problems
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Business decisions.
Each accounted for about an eighth of cases, with raw-material issues making up a small share as well.
Behind that silence sit a few weak spots that show up again and again.
Weak Point #1: Manufacturing is too centralized
A large share of a key drug's supply can rest on a single factory. So one accident becomes a national event. In 2023, a tornado damaged a Pfizer plant that made close to 8% of the sterile injectables used across the country. That one event helped trigger a string of shortages.
In the fall of 2024, Hurricane Helene flooded a Baxter plant in Marion, North Carolina. It was one of the largest sources of IV and dialysis fluids in the United States. By some estimates, it supplied about 60% of the nation's IV fluids. The FDA helped restart the plant in about 60 days and allowed emergency imports of millions of units from overseas. Still, the flood showed how thin the margin really is.
Week Point #2: The supply chain reaches far overseas.
About 60% of the active ingredients in U.S. prescription drugs come from India, China, and the European Union. That leaves whole groups of medicine exposed to political tension abroad and to failures at suppliers most Americans will never hear of.
Week Point #3: Generics aren't as profitable.
Many essential drugs in shortage are cheap generics. Their profit margins are so thin that makers have little reason to expand or even to enter the market. An IQVIA study found that 37% of generics approved between 2013 and early 2024 never launched at all. It also found that most approved generics take more than four years to reach patients.
When a drug is approved but never made, the market will not fix the shortage on its own.
Surprise Demand Also Impacts Shortages
Not every recent shortage came from a broken factory. Two of the most visible ones came from demand shooting past supply. Both became household news.
ADHD stimulants landed on the FDA's shortage list in October 2022 and have stayed there. They are tangled up with the DEA's power to cap how much of a controlled drug makers can produce. In 2024, the FDA formally asked the DEA to raise the production limit for lisdexamfetamine, a common ADHD medicine. The DEA granted the increase that September. Pharmacists have also warned about a DEA change that sets stimulant limits every three months instead of once a year. They say it makes it harder for makers to plan efficient production runs.
The GLP-1 drugs tell a similar story from the business side. These are the weight-loss and diabetes drugs sold as Ozempic, Wegovy, Mounjaro, and Zepbound. Demand for them roughly doubled after 2020. It outran even a big push to build new factories, and the drugs sat on the shortage list for months. As new capacity came online, those shortages have mostly eased.
As we can see from these examples, demand-driven shortages usually don't last as long, since the money that comes with them usually incentivizes fast increases on the supply-side.
How National & State Governments Respond
Drug shortages have become a lasting item on the agenda in Congress. The government response now runs on several tracks at once.
The FDA leans on a familiar set of tools. It speeds up reviews and inspections for makers trying to restart or grow production. It extends expiration dates when safety data allows. And it bends some rules on a temporary basis. In 2024, the agency fast-tracked 225 filings, moved 20 inspections up the line, and used this kind of flexibility 107 times. It has also pushed makers to build stronger quality systems through a voluntary program, since quality problems sit underneath many shortages. In 2024 it opened a public website so doctors and patients can report new gaps directly.
The limits of these tools are getting clearer. In April 2025, the Government Accountability Office reported that the Department of Health and Human Services still had no formal way to coordinate shortage work across the FDA and its sister agencies. The GAO also kept the FDA's oversight of drug shortages on its High-Risk List. As the FDA itself has said, it cannot solve the problem alone.
States have stopped waiting. Their approaches differ, but most fall into a few buckets. Some stockpile critical medicines. Some give pharmacists more room to swap in backup drugs. And some push for more transparency. A proposed New York law would create a public, searchable list of drugs in shortage, along with the pharmacies that still stock them. In 2025, Hawaii's Medicaid program adopted a plan that lets foreign-approved drugs fill in when a medicine is short. Federal regulators, for their part, finalized a rule to help small hospitals keep a backup supply of essential drugs.
How Can We End These Shortages?
Put the two sources side by side, and the path forward comes into focus. The early-warning system Congress built after the 2011 crisis works. Fewer shortages start now, and the FDA heads off hundreds more before they surface. What the system has not solved is how long shortages last. The ones that do take hold now dig in for years. They cluster in the cheap, single-source, injectable drugs that hospitals depend on and the market keeps refusing to fix.
The headline number will keep bouncing between a few dozen and a few hundred, depending on who is counting and when. The more telling figure is the one that barely moves. It is the share of shortages that have already lasted longer than two years, and the patients quietly routed around them the entire time.
Sources and methodology
- U.S. Food and Drug Administration, Report to Congress: Drug Shortages CY 2024 (annual new-shortage counts, prevented-shortage counts, ongoing-shortage totals, regulatory actions, DEA coordination, and the Baxter and lisdexamfetamine cases).
- FDA Center for Drug Evaluation and Research (CDER) drug shortage database.
- American Society of Health-System Pharmacists (ASHP) and the University of Utah Drug Information Service, drug shortage statistics (active-shortage counts, category breakdowns, duration, and stated causes).
- U.S. Government Accountability Office, GAO-25-107110 (April 2025), on shortage duration and interagency coordination.
- IQVIA Institute, research on drug shortages and generic launch rates.
- National Association of Boards of Pharmacy, analysis of chronic medication shortages, and reporting by trade and news outlets for supply-chain and state-policy detail.
