Drug Withdrawals and Recalls: Why Medications Get Removed from the Market

When a drug is pulled from the market, it’s not just a corporate decision - it’s a safety alert. Millions of people rely on prescription medications every day, and when those drugs turn out to be unsafe or ineffective, the consequences can be serious. In recent years, high-profile cases like the withdrawal of Makena a drug approved in 2011 for preventing preterm birth, later withdrawn in 2022 after confirmatory trials showed it provided no benefit have exposed deep flaws in how the U.S. Food and Drug Administration (FDA) handles failed drugs. The system wasn’t built for speed. It was built for caution. But caution, when it takes years, can cost lives.

How Drugs Get Approved - and Why They Get Pulled

The FDA doesn’t approve drugs because they’re perfect. It approves them because, based on available data, their benefits outweigh their risks. For many drugs - especially those treating serious or life-threatening conditions - the agency uses a fast-track process called accelerated approval a pathway allowing drugs to reach patients based on surrogate endpoints, like tumor shrinkage, rather than long-term outcomes like survival. This means a drug can be on the market for years before its real-world effectiveness is fully confirmed. That’s where things go wrong.

Between 2010 and 2020, about 12.7% of drugs approved under this fast-track system were eventually withdrawn. That’s one in eight. And in some cases, like a drug for small cell lung cancer, more than 41% of eligible patients received it - even after studies showed it didn’t work. The problem? The FDA had no legal power to act quickly. Sponsors could delay required follow-up studies indefinitely. The agency could only watch.

The Old System: Years of Waiting

Before 2023, the FDA’s ability to remove a drug from the market was painfully slow. A 2023 study from the Penn LDI found that, on average, it took 46 months - nearly four years - to withdraw a drug after evidence showed it was ineffective. Compare that to the average approval time of about 12 months. That’s a 3.8-year gap between approval and removal. In the case of Makena, it took over 1,500 days to withdraw approval after the confirmatory trial failed. During that time, an estimated 150,000 patients received a drug that didn’t help them.

Why so long? The process was bureaucratic. The FDA had to notify the drugmaker, allow time for appeals, open public comment periods, and sometimes convene advisory committees. There was no deadline. No urgency. And patients paid the price.

The 2023 Change: A New Ruleset

The Consolidated Appropriations Act of 2023 changed everything. For the first time, the FDA gained real power to act fast. Under the new rules, the agency can now initiate a streamlined withdrawal process if:

• The drug sponsor fails to conduct required post-approval studies
• The confirmatory study doesn’t verify the drug’s benefit
• Independent data proves the drug is unsafe or ineffective
• The company spreads false or misleading claims about the drug

The process now has clear deadlines: the sponsor has 30 days to respond to a withdrawal notice, a meeting with FDA leadership can happen within 60 days, and a final decision must be made within 180 days. That’s not perfect - but it’s a massive improvement over the old system.

Who Gets Affected? Patients, Doctors, Pharmacies

When a drug is withdrawn, it’s not just the manufacturer that feels the impact. Patients are caught off guard. Oncologists report that about 30% of their patients on accelerated approval drugs between 2015 and 2020 were prescribed therapies later pulled from the market. One breast cancer patient shared on a patient forum: “I was on [withdrawn drug] for 18 months before the trial failed. My doctor said it was standard care at the time.”

Pharmacists struggle too. A 2022 survey found 63% had trouble interpreting the FDA’s Orange Book the official list of approved drug products with therapeutic equivalence evaluations, updated monthly to determine if a drug was withdrawn. That means patients might walk into a pharmacy and get a drug that’s no longer approved - because no one told the pharmacist.

And doctors? They’re left scrambling. When a drug is pulled, practices have, on average, just 72 hours to find a replacement treatment for patients who were stable on it. That’s not enough time to review alternatives, check insurance coverage, or educate patients.

Why This Matters Beyond Cancer Drugs

Most of the withdrawn drugs are in oncology - because that’s where accelerated approval is most common. But the same risks exist for drugs treating Alzheimer’s, rare diseases, and even chronic conditions like high cholesterol. The FDA has approved over 80 drugs through accelerated pathways since 2010. About 26% of those have been withdrawn. That’s not a small number. It’s a pattern.

The new 2023 rules only apply to drugs approved after the law passed. So drugs like Makena, approved in 2011, are still stuck in the old system. That means more patients will keep getting drugs that don’t work - until the FDA finds a way to apply the new rules retroactively. For now, the system is still broken for many.

What’s Next? Real-World Data and Faster Decisions

The FDA is now piloting the use of real-world data from sources like Flatiron Health to monitor how drugs perform outside clinical trials. Instead of waiting years for a confirmatory study, the agency could spot problems faster by analyzing how thousands of patients respond in real time.

The goal? Cut withdrawal time from 46 months to under 12. Commissioner Robert Califf says that’s achievable. But experts warn: speed without rigor could lead to premature withdrawals. A drug that looks ineffective in early data might still help a small group of patients. The challenge is balancing safety with access.

What Patients Should Do

If you’re on a medication approved under accelerated approval - especially for cancer, rare diseases, or serious conditions - ask your doctor:

• Is this drug approved under accelerated approval?
• Are there any pending confirmatory studies?
• Has the FDA issued any public notices about this drug?

You can check the FDA’s Orange Book or search the Federal Register for notices of proposed withdrawal. Don’t assume your doctor knows. Many don’t.

Why This Isn’t Just About One Drug

Makena wasn’t the first drug withdrawn. It won’t be the last. But it became the symbol of a broken system. The FDA didn’t act because it didn’t have the power - not because it didn’t see the problem. The 2023 reforms were a wake-up call. They didn’t fix everything. But they gave the agency the tools to act.

The real test isn’t whether the FDA can move faster. It’s whether it will - when the evidence is clear, and lives are on the line.