Drug shortages arenât just inconveniences-theyâre life-or-death emergencies. In 2024, over 300 drugs were in short supply across the U.S., with oncology drugs, antibiotics, and anesthetics hitting the hardest. Hospitals scrambled. Patients skipped doses. Pharmacists spent hours tracking down alternatives. And yet, the federal governmentâs response has been fragmented, inconsistent, and often too late.
Whatâs Actually Being Done?
The biggest federal move in 2025 was the expansion of the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR). Originally created in 2020, this program was dramatically scaled up under Executive Order 14178 in August 2025. Instead of stockpiling finished drugs-which expire quickly and cost more-the government is now hoarding the raw chemical building blocks: active pharmaceutical ingredients (APIs). Why APIs? Because theyâre cheaper to store, last 3-5 years longer than pills or injections, and can be turned into multiple drugs. The goal is to have enough of 26 critical APIs on hand to keep essential medicines flowing during crises. These include drugs like cisplatin for cancer, epinephrine for allergic reactions, and vancomycin for severe infections. But hereâs the catch: only 26 drugs. Thatâs less than 5% of all shortage-prone medications. The FDAâs own data shows oncology drugs alone make up 31% of all shortages, yet only 4% of the SAPIR list covers them. Most of the other 95% of drugs-like insulin, thyroid meds, or common antibiotics-are left to fend for themselves.The FDAâs Role: Reactive, Not Preventive
The FDA handles most day-to-day shortage management. When a manufacturer says a drug might run out, the agency can speed up inspections, approve temporary imports, or nudge other companies to ramp up production. In 2024, they resolved 85% of reported shortages this way. That sounds good-until you look at the bigger picture. Manufacturers are legally required to report potential shortages six months in advance. But only 58% actually do. For small companies with fewer than 50 employees, that number drops to 18%. That means the FDA is often playing catch-up. By the time they know about a problem, the drug is already gone from shelves. To fix this, the FDA launched its Enhanced Shortage Monitoring System in November 2025. It uses AI to track 17 data streams: shipping logs, hospital purchase patterns, factory output reports, even weather disruptions at overseas plants. It predicts shortages with 82% accuracy, up to 90 days ahead. Thatâs a real improvement. But itâs still just a warning system. It doesnât fix the root problem: too few companies making too few drugs, with no backup.Why Are We Still So Vulnerable?
The U.S. relies on foreign countries for nearly 80% of its APIs. China alone supplies most of the raw materials for antibiotics, painkillers, and heart medications. The EU has mandatory stockpiling rules and centralized tracking. The U.S. doesnât. The EU cut its shortages by 37% between 2022 and 2024. The U.S. hit record highs. Even when the government tries to bring production home, itâs slow. It takes 28-36 months to get a new API plant approved by the FDA. In the EU, itâs 18-24 months. Meanwhile, just three companies control 68% of the U.S. sterile injectable market. If one factory shuts down-due to contamination, fire, or labor strike-dozens of drugs vanish overnight. The economics make no sense. These essential drugs donât make much profit. A vial of saline costs less than $1. A hospital might pay $5 for it. But building a factory to make it? That costs $200 million. Why would a company invest when they can buy it cheaper from overseas and still make money?
Whatâs Failing Behind the Scenes
The 2025-2028 HHS Draft Action Plan sounds ambitious: Coordinate. Assess. Respond. Prevent. But only 35% of its recommended actions have been implemented across federal agencies. The Government Accountability Office found HHS doesnât even have consistent ways to measure whether its programs work. Funding is another issue. The Biomedical Advanced Research and Development Authority (BARDA), which once supported new manufacturing tech, saw its budget cut by 22% in 2026. FEMAâs emergency drug response funds dropped too. Meanwhile, Congress is debating bills like H.R.5316, which would let hospitals use compounded versions of shortage drugs during emergencies. Thatâs helpful-but itâs a Band-Aid. It doesnât stop the shortage from happening. And hereâs the most troubling part: the administration rolled back Biden-era rules that forced drugmakers to disclose supply chain risks. Transparency was a tool. Now itâs gone.Real People, Real Consequences
Behind every shortage statistic is a patient, a nurse, a pharmacist. A cancer patient in Ohio had to switch from cisplatin to a less effective alternative because the original was out of stock. Her tumor shrank slower. Her oncologist had to adjust her entire treatment plan. A rural hospital in West Virginia couldnât get enough epinephrine for emergency rooms. They started using a different brand, but the concentration was off. Nurses had to calculate doses by hand. One nurse told a reporter, âI spent two hours double-checking a single syringe. I didnât sleep that night.â Pharmacists now spend 10+ hours a week just managing shortages. 41% report near-miss errors because they had to swap drugs on the fly. 29% of Americans have skipped doses because a drug wasnât available-not because they couldnât afford it, but because it simply wasnât there. The American Hospital Association says hospitals now spend $1.2 million a year just handling shortages. Thatâs money taken from patient care, staff training, or new equipment.
Is There a Better Way?
Experts agree: stockpiling APIs helps in emergencies, but it doesnât fix the system. The real solution needs three things:- Second-source manufacturing: Require every critical drug to have at least two approved U.S. manufacturers. Right now, most have one. Thatâs a single point of failure.
- Financial incentives: Pay companies more to make low-margin essential drugs. Maybe through guaranteed contracts or price floors. Right now, thereâs no profit in saving lives.
- Mandatory reporting: Enforce the six-month notice rule. Fine companies that donât report. The FDA issued only 17 warning letters between 2020 and 2024. The EU issued 142 under similar rules.
What Comes Next?
The next 18 months will tell us if this is real change-or just another round of headlines and empty promises. If the 14 new manufacturers get approved, and if Congress passes funding for domestic production, and if hospitals finally get the tools to track shortages in real time, then maybe we start seeing fewer emergencies. But if the API reserve stays limited to 26 drugs, if funding keeps getting cut, and if manufacturers still donât have to report risks-then weâll be right back here in 2026, watching another wave of shortages hit. The problem isnât that we donât know how to fix it. We do. We just havenât chosen to pay the price.Why are drug shortages getting worse despite federal action?
Federal efforts like the Strategic API Reserve help in emergencies, but they donât fix the root causes: lack of financial incentives to produce low-margin drugs, extreme market concentration (three companies control 68% of sterile injectables), and weak enforcement of reporting rules. Most shortages happen outside the 26 drugs covered by the reserve, and manufacturers still arenât required to report risks reliably.
How does the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) work?
SAPIR stockpiles raw chemical ingredients (APIs) instead of finished drugs. These ingredients can be turned into multiple medications and last 3-5 years longer than pills or injections. The program targets 26 essential drugs, including antibiotics and cancer treatments, and aims to prevent shortages by ensuring manufacturers have access to critical raw materials during disruptions. Itâs cheaper and more efficient than stockpiling finished products.
What percentage of U.S. pharmaceutical ingredients come from China?
Approximately 80% of active pharmaceutical ingredients (APIs) used in U.S. medications are produced in China. This includes key ingredients for antibiotics, painkillers, and heart medications. The U.S. government has tried to reduce this dependence, but progress has been slow due to cost, regulatory delays, and lack of domestic manufacturing capacity.
Can hospitals make their own drugs during shortages?
Yes, under emergency rules, hospitals with specialized compounding labs can make certain drugs from raw ingredients when commercial supplies run out. This is allowed under H.R.5316 and FDA emergency guidance. But itâs not simple-compounding drugs like cisplatin requires trained staff, sterile environments, and regulatory approval. Only larger hospitals have this capability, leaving rural and community hospitals vulnerable.
Why arenât more drug manufacturers in the U.S.?
Making generic drugs like saline or antibiotics doesnât pay well. The profit margins are thin, and building a FDA-approved manufacturing facility costs $100-$200 million. Companies prefer to produce higher-margin drugs or outsource to cheaper overseas plants. Even with recent federal funding, the U.S. has only added a handful of new domestic API facilities since 2020, and many are still overseas.
Whatâs the most effective federal tool to reduce drug shortages?
According to Johns Hopkins research published in JAMA Internal Medicine in September 2025, the most effective tool is mandatory early reporting of potential shortages. Hospitals and manufacturers using the FDAâs Early Notification Pilot Program saw 28% shorter shortage durations. But the current administration has weakened these reporting requirements. Enforcement-like fines for non-compliance-is the missing piece.
Andrew Gurung
December 28, 2025 AT 03:30Paula Alencar
December 29, 2025 AT 04:03And yet, we wonder why nurses cry in supply closets.
Nikki Thames
December 29, 2025 AT 16:22And now weâre surprised when people die?
Will Neitzer
December 30, 2025 AT 02:31Chris Garcia
December 31, 2025 AT 06:19James Bowers
January 2, 2026 AT 06:16Alex Lopez
January 3, 2026 AT 20:28Gerald Tardif
January 5, 2026 AT 01:14