For most Americans, a generic pill costs less than $5. But behind that low price tag is a complex, expensive, and often frustrating regulatory maze. The FDA doesn’t just approve drugs - it charges companies tens of thousands of dollars just to apply. And for generic drugs, those fees add up fast. In 2025, a single generic drug application can cost over $375,000 just in FDA fees alone. That’s not including the millions spent on research, testing, and reformulation. This isn’t just bureaucracy - it’s a hidden tax on affordable medicine.
What You Pay Just to Apply
The FDA doesn’t fund its generic drug reviews with taxpayer money. Instead, it collects fees from drugmakers under the Generic Drug User Fee Amendments (GDUFA). This system started in 2013 and was renewed in 2022 under GDUFA III. For fiscal year 2025, the total fee structure is nearly $639 million. Of that, generic drug applications (called ANDAs) make up about one-third - $211 million. That breaks down into three main fees: a $136,485 product fee per drug, a $238,055 facility fee per manufacturing site, and a separate application fee. Small companies with fewer than 1,000 employees can get waivers, but most mid-sized manufacturers pay full price.
Compare that to brand-name drugs. A New Drug Application (NDA) costs $3.7 million in 2025. That’s nearly 10 times more. But here’s the twist: generics make up 90% of all prescriptions filled in the U.S., yet they account for only 12% of total drug spending. That’s because they’re cheaper to make - but not cheaper to get approved.
The Hidden Cost: Reformulation Roulette
It’s not just the upfront fees. The real financial trap comes after submission. In 2015, the FDA stopped giving specific feedback on the chemical makeup of generic drugs - especially complex ones like nasal sprays, inhalers, or injectables. Before that, companies could ask the FDA: "Is this formulation close enough?" Now, they’re left guessing. One company spent $8.7 million and three separate reformulation attempts over five years just to get a single nasal spray approved. That’s not an outlier. A 2025 analysis by Patients Rising found that 30% of complex generic applications go through multiple review cycles, compared to just 15% for simpler ones.
Each failed review means a Complete Response Letter (CRL). Responding to a CRL costs $2 million to $5 million and adds 8 to 12 months to the timeline. For a drug that could save patients $1,200 a month - like a generic version of apixaban - that delay means thousands in out-of-pocket costs for people who can’t afford the brand-name version.
Why It Takes So Long - And Why It Matters
The FDA says it targets an 11-month review time for standard generics. In reality, it’s 11.2 months on average. For complex generics, it’s often 18 to 24 months. And only 42% of complex applications get approved on the first try. That’s down from 65% for simpler drugs. Meanwhile, the paperwork has ballooned. ANDA submissions now average 150,000 to 200,000 pages. A decade ago, it was half that. Deloitte estimates this increase added 35% to preparation costs.
Meanwhile, patients pay the price. Between 2016 and 2020, generic versions of testosterone replacement therapy were delayed for 4.7 years. During that time, patients paid 300% more for the brand. On Reddit, one patient wrote: "I’m paying $1,200 a month for my generic glipizide because the FDA won’t approve the cheaper version." That thread had 147 comments - all from people in the same boat.
Who Benefits? Who Loses?
On one side, the system protects patients. In 2022, a valsartan recall affected 22 million people because of contamination. Pharmacists argue that the extra scrutiny prevents that kind of disaster. One New York pharmacist put it bluntly: "Better to wait a year than give someone a toxic pill."
But on the other side, the delays hurt competition. In 2024, 83% of brand-name drugs had no generic competitor even five years after their patent expired. That’s not because no one tried - it’s because the cost and uncertainty make it too risky. Big pharma benefits. Small generic makers struggle. And patients? They’re stuck paying more.
The Push for Change
In September 2025, Congress introduced H.R. 1843 - the "Increasing Transparency in Generic Drug Applications Act." It’s backed by both Republicans and Democrats, with 72 co-sponsors. The bill would force the FDA to go back to giving detailed feedback on formulation. The Congressional Budget Office estimates this would cut approval times for complex generics by 18 to 24 months. That could bring 12 to 15 new generics to market each year, saving $1.8 billion to $2.3 billion annually.
The FDA isn’t opposed to faster approvals - but it’s worried about resources. In July 2025, its Office of Generic Drugs warned that without more staff or funding, restoring detailed feedback could slow down other reviews and risk quality. They’re now preparing for GDUFA IV, which will cover 2028 to 2032. Industry groups want fee increases of 3% to 5% per year to hire more reviewers. The FDA estimates it will need $725 million to $750 million annually just to meet its goals.
What This Means for You
If you take a generic drug, you’re already saving money. But the system is designed to make those savings harder to achieve. The $467 billion in savings from generics in 2024 didn’t happen by accident. It happened despite a regulatory system that makes approval expensive, slow, and unpredictable. Every delay in approval means someone pays more. Every failed application means fewer options. Every CRL means another year of high prices.
The solution isn’t to cut corners. It’s to make the process smarter. Give manufacturers clear feedback. Fund the FDA properly. Reduce paperwork that doesn’t improve safety. The goal isn’t speed for speed’s sake - it’s speed that gets affordable drugs to people who need them.
Right now, the system works for big companies with deep pockets. It doesn’t work for patients. And unless Congress acts, it won’t get better.
How much does it cost to get a generic drug approved by the FDA?
The total cost to submit one generic drug application (ANDA) in 2025 is about $375,000 in FDA fees alone. This includes a $136,485 product fee, a $238,055 facility fee, and additional application fees. This doesn’t include the millions more spent on research, testing, and reformulation - especially for complex generics.
Why are generic drug approvals taking so long?
The FDA stopped giving specific feedback on the chemical formulation of complex generics in 2015. Companies now have to guess what changes the agency wants, leading to multiple rounds of reformulation. This trial-and-error process can add 2-3 years to development. Review times average 11.2 months for standard generics and longer for complex ones, with only a 42% first-cycle approval rate for complex products.
Do generic drugs save money overall?
Yes - dramatically. In 2024, generics saved the U.S. healthcare system $467 billion. They made up 90% of all prescriptions filled but only 12% of total drug spending. Medicare beneficiaries saved an average of $1,152 per person just from using generics. The problem isn’t that generics are expensive - it’s that the approval process makes them harder to bring to market.
What’s H.R. 1843 and why does it matter?
H.R. 1843 is a bipartisan bill introduced in September 2025 that would require the FDA to resume giving detailed feedback on generic drug formulations. This could cut approval times for complex generics by 18-24 months and bring 12-15 new generics to market each year. The Congressional Budget Office estimates it would save $1.8-$2.3 billion annually and up to $23 billion over five years.
Why doesn’t the FDA just approve generics faster?
The FDA says it’s under-resourced. Even though user fees bring in over $600 million a year, the agency says inflation and growing application complexity strain its ability to review quickly without compromising safety. They’re concerned that if they restore detailed feedback without hiring more staff, review quality could drop - risking patient safety. The debate is between speed and safety - and both matter.
