How FDA Approval Costs for Generics Impact Drug Prices and Patient Access

When you pick up a generic pill at the pharmacy, you’re saving money-often hundreds or even thousands of dollars compared to the brand-name version. But behind that low price tag is a complex, expensive, and sometimes broken system. The FDA approval costs for generic drugs aren’t just a line item on a corporate balance sheet. They directly affect how fast a life-saving medication reaches patients, how much it costs, and whether it’s available at all.

What You’re Really Paying For

The FDA doesn’t approve generic drugs for free. Under the Generic Drug User Fee Amendments (GDUFA), drugmakers pay fees just to get their application reviewed. For FY 2025, the total fee structure is $638.96 million. Of that, $210.86 million comes from ANDA (Abbreviated New Drug Application) fees-the core cost for getting a generic approved. That breaks down to roughly $136,485 per product application, plus $238,055 per manufacturing facility. For a small company trying to bring out one generic drug, that’s nearly $400,000 just to submit the paperwork.

That’s a lot, but it’s nothing compared to brand-name drugs. Under PDUFA, the fee for a single New Drug Application (NDA) is $3.685 million. So why does the generic fee seem so high? Because it’s not just about the fee. It’s about what happens after you pay it.

The Hidden Cost: Reformulation Roulette

Here’s where things get messy. In 2015, the FDA changed how it handles complex generics-drugs like inhalers, nasal sprays, or injectables with tricky delivery systems. Before that, the agency gave manufacturers detailed feedback on why a formulation didn’t match the brand. Now? They say, “It’s not the same,” and walk away.

That forces companies into a guessing game. One mid-sized generic manufacturer told RAPS in 2024 they spent $8.7 million on three separate reformulation attempts for a single nasal spray since 2018. Each try took 12-18 months. Each failure meant more lab work, more testing, more fees. That’s not innovation. That’s bureaucratic trial and error.

The result? Approval timelines for complex generics have stretched from 10-12 months to 18-24 months on average. First-cycle approval rates for these products dropped to 42%, compared to 65% for simple pills. And when the FDA sends a Complete Response Letter (CRL), it costs $2-5 million and adds 8-12 months to the timeline.

Who Pays the Price?

Patients pay the biggest price. Between 2016 and 2020, generic versions of testosterone replacement therapy were delayed by 4.7 years. During that time, patients paid 300% more for the brand-name version. On Reddit, users are posting about paying $1,200 a month for a drug like apixaban because the generic isn’t approved yet. One patient wrote: “I skipped doses because I couldn’t afford it. Then I ended up in the ER.”

It’s not just individual hardship. Medicare Part D saved $1,152 per enrollee in 2024 thanks to generics. But if approval delays keep pushing back market entry, those savings vanish. In 2024, 83% of brand-name drugs still had no generic competition five years after their patent expired. That’s not because no one wants to make the generic. It’s because the system makes it too expensive and too slow.

Why the FDA Can’t Just Say Yes

The FDA isn’t being cruel. They’re stretched thin. In 2023, the average review time for a standard ANDA was 11.2 months-slower than the 10-month goal. Why? Because ANDA submissions now average 150,000-200,000 pages of documentation. That’s triple what it was under GDUFA I in 2013. Reviewers are drowning in paper.

And here’s the catch: the FDA’s own data shows that when they do give detailed feedback, approval rates go up. Companies that used Type II meetings (early discussions with FDA reviewers) cut their review time by 3.2 months on average. But those meetings aren’t mandatory. And they cost time and money-something small manufacturers can’t always afford.

Meanwhile, the 2022 valsartan recall, which affected 22 million patients, keeps regulators cautious. One pharmacist on Pharmacy Times wrote: “The extra scrutiny prevents quality issues.” That’s true. But is the cost of that caution worth the human toll?

The Push for Change

There’s a bill in Congress trying to fix this. H.R. 1843, the “Increasing Transparency in Generic Drug Applications Act,” was introduced in September 2025 by Rep. Neal Dunn and Rep. Kevin Mullin. It would force the FDA to restore detailed formulation feedback for complex generics.

The Congressional Budget Office estimates this could cut approval times by 18-24 months for complex drugs and generate $1.8-2.3 billion in annual savings. Over five years, that’s $18-23 billion in healthcare savings. And it’s not just patient advocates pushing for it. The Generic Pharmaceutical Association says 30% of complex generic applications now face multiple review cycles-double the rate of standard generics.

The FDA isn’t opposed to change. At a July 2025 public meeting, they acknowledged that “resource constraints have impacted our ability to provide timely feedback.” But they also warned: “Reversing the 2015 policy without additional funding could compromise review quality.” Translation: If you want faster approvals, you need more staff. And more staff means higher fees.

What’s Next?

GDUFA III expires in September 2027. Negotiations for GDUFA IV are already underway. Industry groups are pushing for a 3-5% annual fee increase to hire more reviewers. The FDA estimates it will need $725-750 million per year to meet new goals.

The agency has also announced plans to accelerate approval for 15 high-priority complex generics by 2027. That’s a start. But it’s not a system fix.

Meanwhile, generics saved $467 billion in 2024-90% of all prescriptions filled, but only 12% of total drug spending. That’s the power of competition. And it’s all under threat from a system that’s become too slow, too expensive, and too opaque.

Bottom Line: It’s Not About the Fee

The real issue isn’t that generic drug approval costs too much. It’s that the cost isn’t transparent, predictable, or fair. When a company spends millions just to get feedback on a formulation, or when a patient pays $1,200 a month because a generic is stuck in limbo, the system has failed.

The FDA needs more resources. But it also needs to stop treating complex generics like a puzzle with no solution. Give manufacturers clear feedback. Reduce the paperwork. Speed up the process. The savings are already there. The question is whether we’re willing to remove the roadblocks.