Drug shortages in the U.S. aren’t just inconveniences-they’re life-or-death emergencies. In 2024, over 300 medications were in short supply, from antibiotics and chemotherapy drugs to IV fluids and anesthetics. Hospitals scrambled. Patients delayed treatments. Pharmacists spent hours each week tracking down alternatives. And while the federal government has rolled out a series of new actions, the real question isn’t whether they’re acting-it’s whether those actions actually fix what’s broken.
What’s Really Causing the Shortages?
It’s easy to blame foreign suppliers, and yes, about 80% of the active pharmaceutical ingredients (APIs) used in U.S. drugs come from China and India. But that’s only part of the story. The deeper problem is economic. Making low-margin, high-volume drugs like saline or insulin isn’t profitable. Manufacturers don’t invest in backup lines or extra inventory because there’s no financial reward. Just three companies control nearly 70% of the sterile injectable market. If one factory shuts down-due to a fire, inspection failure, or supply glitch-dozens of drugs vanish overnight.
And it’s not just about production. The FDA’s approval process for new manufacturing sites takes 28 to 36 months in the U.S., compared to 18 to 24 in the EU. That delay keeps companies from expanding capacity. Meanwhile, only 58% of manufacturers even report potential shortages as required by law. Small companies? The rate drops to 82%. Without reliable data, the government can’t predict or prevent problems-it’s always playing catch-up.
The Strategic Active Pharmaceutical Ingredients Reserve (SAPIR)
In August 2025, President Trump signed Executive Order 14178, expanding the Strategic Active Pharmaceutical Ingredients Reserve (a federal stockpile of raw drug ingredients designed to prevent critical medicine shortages). This isn’t about storing finished pills or injections. It’s about storing the building blocks-the APIs-that go into them.
Why? Because APIs are cheaper to store, last 3 to 5 years longer than finished drugs, and can be turned into multiple products. The program targets 26 essential medicines: antibiotics like vancomycin, anesthetics like propofol, and oncology drugs like cisplatin. The idea is simple: if a shortage hits, the government can quickly send raw material to domestic manufacturers to ramp up production.
But here’s the catch. The 26 drugs on the list cover only 4% of all shortage-prone medications. Meanwhile, oncology drugs alone make up 31% of all shortages-and only a handful are included. Experts like Dr. Luciana Borio call this approach "reactive," not preventative. Stockpiling helps when disaster strikes, but it doesn’t stop the disaster from happening in the first place.
The HHS Draft Action Plan: Goals That Sound Good, But Don’t Add Up
The Department of Health and Human Services released its 2025-2028 Draft Action Plan with four pillars: COORDINATE, ASSESS, RESPOND, and PREVENT. Sounds solid. But look closer.
- COORDINATE: Agencies are supposed to share data. But the Government Accountability Office found only 35% of ASPR’s recommended actions have been adopted across departments.
- ASSESS: A new dashboard is meant to track supply chains in real time. Yet, only 28 of 50 states have set up the required mapping systems. Rural hospitals lack the tech to use it.
- RESPOND: The FDA can now approve emergency imports faster. That helped during the 2018 saline shortage, but it’s a band-aid, not a cure.
- PREVENT: The plan encourages domestic manufacturing-but offers no real incentives. Companies won’t build new plants if they can’t make money on the drugs they produce.
The real problem? No standardized way to measure success. HHS doesn’t track whether its programs actually reduce shortages. It just counts how many meetings were held or how many grants were handed out.
Why the FDA’s Reporting System Is Failing
The FDA has a public Drug Shortage Database (a publicly accessible tool tracking over 1,200 active and resolved drug shortages since 2012). It’s useful-but broken. Manufacturers are legally required to report potential shortages six months in advance. But compliance is patchy. Big companies? About 70% report. Small ones? Only 18% do.
And even when they report, the FDA doesn’t enforce penalties. Between 2020 and 2024, the agency issued just 17 warning letters for missed reports. The EU issued 142 under similar rules. That’s not oversight-that’s neglect.
The FDA’s new AI-powered monitoring system, launched in November 2025, tries to fill the gap. It uses 17 data sources-from shipping logs to hospital purchase patterns-to predict shortages 90 days ahead with 82% accuracy. That’s promising. But it’s still reactive. If the system predicts a shortage, what does it do? It waits for someone else to act.
What’s Missing: Economic Incentives and Second-Source Manufacturing
Here’s the truth no one wants to say out loud: The government can’t fix drug shortages without fixing the business model.
Consider this: The U.S. spends $5.2 billion a year managing drug shortages, according to IQVIA. Yet, there’s no system to reward manufacturers who build redundant production lines. No bonus for companies that make the same drug in two different factories. No subsidies to cover the cost of maintaining low-margin supply chains.
That’s why the most promising move in 2025 was the FDA’s announcement of expedited review pathways for second-source manufacturers. Fourteen applications are already in process. If approved, they could add backup supply for eight critical drugs by mid-2026. That’s a start.
Compare that to the EU. Since 2022, the European Medicines Agency has required member states to maintain mandatory stockpiles and share real-time shortage data. Result? A 37% drop in shortages over two years. The U.S. has no such requirement. No mandate. No accountability.
The Human Cost: What Happens When Drugs Disappear
Behind every shortage number is a patient. A cancer patient who gets a less effective drug because the original isn’t available. A mother whose child’s antibiotic was swapped out, leading to a longer hospital stay. A nurse who has to double-check every dose because the new substitute has different dosing rules.
Hospitals report spending an average of $1.2 million per year just managing shortages. Pharmacists spend 10+ hours a week tracking down alternatives. In 2025, 42% of healthcare facilities reported medication errors directly linked to substitution. And 29% of Americans skipped doses because they couldn’t get their medication-regardless of cost.
On Reddit, pharmacists shared stories of compounding cisplatin from raw powder because the pre-made version was gone. One hospital used five different manufacturers for the same drug in a single week. That’s not innovation. That’s chaos.
What’s Working? The Early Notification Pilot
Here’s one thing that actually worked: the FDA’s Early Notification Pilot Program. Hospitals and manufacturers that reported potential shortages early saw their shortages last 28% less time. Why? Because the FDA could step in faster-helping with inspections, approvals, or imports.
That program was voluntary. And now, under the 2025 budget cuts, it’s being scaled back. The very tool that proved most effective is being quietly dismantled.
Looking Ahead: Can This Be Fixed?
There are signs of progress. The $285 million in CHIPS Act funding for domestic manufacturing is a start. The AI forecasting system could be powerful-if it’s connected to real action. The second-source review pathway might reduce single-point failures.
But the core issues remain untouched. No one is paying manufacturers to make the drugs everyone needs. No one is forcing companies to build backup lines. No one is holding agencies accountable for tracking results.
The government’s response in 2025-2026 is a patchwork of emergency measures. It’s like putting out fires with buckets of water while ignoring the wiring that keeps sparking. Stockpiling APIs helps. Predicting shortages helps. But without economic incentives, without mandatory reporting, without real accountability-this cycle will keep repeating.
The next time a hospital can’t find a life-saving drug, ask: Was this preventable? The answer, more often than not, is yes.
Why does the U.S. have more drug shortages than other countries?
The U.S. lacks mandatory stockpiling requirements, real-time supply chain reporting, and financial incentives for manufacturers to produce low-margin drugs. The EU, by contrast, requires member states to maintain reserves and share data, which cut shortages by 37% between 2022 and 2024. The U.S. system relies on voluntary reporting and reactive fixes, not structural prevention.
How many drugs are currently in shortage?
As of late 2025, the FDA reported 98 active shortages, but other sources like the American Hospital Association counted over 277. The difference comes from how each group defines "active"-some include all drugs with supply issues, while others only count those with no available substitute. The FDA’s public database tracks 1,247 total shortages since 2012, including resolved ones.
What is SAPIR and how does it work?
SAPIR stands for the Strategic Active Pharmaceutical Ingredients Reserve. It’s a federal stockpile of raw drug components-like the active ingredients in antibiotics or chemotherapy drugs-rather than finished pills or injections. The idea is to store these ingredients so they can be quickly turned into medicine during a shortage. It targets 26 critical drugs, is cheaper to maintain than finished products, and aims to reduce reliance on foreign suppliers.
Why aren’t more drug manufacturers making backup supplies?
Making extra production lines for drugs with thin profit margins isn’t profitable. A single vial of saline might cost $0.50 to make but sell for $1.50. There’s no financial reward for building redundancy. Companies focus on high-margin drugs, leaving essential, low-cost medications vulnerable. Without government subsidies or guaranteed contracts, manufacturers won’t invest in backup capacity.
Can the FDA force manufacturers to report shortages?
Yes, by law, manufacturers must report potential shortages six months in advance. But enforcement is weak. Between 2020 and 2024, the FDA issued only 17 warning letters for non-compliance. In the EU, similar rules led to 142 penalties over the same period. Without consequences, reporting remains voluntary in practice, even if it’s mandatory on paper.
What’s the most effective solution to drug shortages?
The most effective solution proven so far is mandatory early reporting combined with incentives for second-source manufacturing. Hospitals using the FDA’s Early Notification Pilot saw shortages last 28% less time. The best long-term fix is paying manufacturers to produce the same drug in multiple locations-creating redundancy. Without that, stockpiles and predictions alone won’t stop future crises.
1 Responses
This isn't a crisis-it's a catastrophe waiting for a press release. They stockpile APIs like they're hoarding toilet paper in a pandemic, but the real problem? No one's paying manufacturers to make the damn stuff. We're treating symptoms while the whole damn system is septic. And don't even get me started on the FDA's 'AI system'-it predicts shortages like a crystal ball that only works when you're already bleeding out. Meanwhile, hospitals are juggling five different versions of the same drug like it's a circus act. One nurse told me she had to memorize dosing charts for five brands of propofol last month. Five. Not because she's a genius-because the system is broken. And now they're CUTTING the Early Notification Pilot? Are they trying to get people killed? This isn't policy. It's negligence with a PowerPoint.