Priority vs Standard Review: How FDA Prioritizes Generic Drug Applications

The U.S. Food and Drug Administration (FDA) doesn’t treat every generic drug application the same. Two paths exist: priority review and standard review. The difference isn’t just paperwork-it’s money, timing, and access to life-saving medications. For generic drug makers, getting priority review can mean launching a product months earlier, capturing market share before competitors, and generating hundreds of millions in revenue. For patients, it means faster access to affordable drugs, especially when there’s a shortage. But how does the FDA decide which applications get the faster track?

What’s the Difference Between Priority and Standard Review?

The FDA sets clear deadlines for each review type under the Generic Drug User Fee Amendments (GDUFA) III, which started in October 2022 and runs through 2027. Standard review takes up to 10 months from the date the application is officially accepted. Priority review cuts that time to 8 months. Sounds simple, right? But here’s the catch: only certain applications qualify for priority review. The rest automatically go to standard.

Think of it like airport security. Standard review is the regular line. Priority review is TSA PreCheck. You don’t get to skip ahead unless you meet specific criteria. And those criteria are strict.

Who Gets Priority Review?

The FDA doesn’t hand out priority review like free samples. It’s reserved for three main types of applications:

• First generics - The very first generic version of a brand-name drug after its patents and exclusivity expire. These are the most valuable because they get 180 days of market exclusivity, meaning no other generic can enter during that time. In 2022, 92.7% of first generics received this exclusivity.
• Drugs in shortage - If a drug is in short supply and patients are at risk, the FDA can fast-track any generic version to help fill the gap. This includes antibiotics, insulin, and other critical medicines.
• Medically important advances - Generic versions that offer real improvements over existing ones, like better stability, fewer side effects, or easier dosing. This category is rare but growing.

These aren’t vague categories. The FDA uses hard data to make the call. For example, if a drug appears on the FDA’s official Drug Shortage List, that alone can trigger priority review. The agency tracks these shortages in real time and responds quickly.

The New Domestic Manufacturing Pilot

In October 2023, the FDA added a new twist: the ANDA Prioritization Pilot Program. This isn’t just about speed anymore-it’s about security. The goal? To bring more generic drug manufacturing back to the United States.

To qualify for priority review under this pilot, a company must prove three things:

1. The bioequivalence studies were done in the U.S.
2. The finished drug is made in a U.S. facility.
3. The active ingredient (API) comes from a U.S.-based supplier.

Why does this matter? In 2021, the FDA reported that 80% of active ingredients for all drugs-brand and generic-were made outside the U.S. That became a huge problem during the pandemic. When supply chains broke, shortages spiked. This pilot is the FDA’s way of forcing companies to build resilience into their supply chains.

But here’s the reality: only 12.3% of generic drug companies currently meet all three criteria. That’s not because they don’t want to. It’s because sourcing U.S.-made APIs and manufacturing facilities for complex drugs is expensive and hard. Many rely on suppliers in India and China because they’ve been doing it for decades.

Why Does This Matter for Patients and Prices?

Generic drugs make up 88.6% of all prescriptions filled in the U.S., but only 15.3% of total drug spending. That’s how they save money. When a first generic hits the market, prices for that drug can drop by 70-90% within months. If the FDA approves that generic 2 months earlier, patients get those savings sooner.

For example, a cardiovascular drug that costs $300 per month as a brand-name pill might drop to $15 after the first generic launches. If that generic gets priority review, thousands of patients get access to that $15 version two months earlier than they otherwise would. That’s thousands of dollars saved per patient in just 60 days.

And it’s not just about cost. When a drug is in short supply, patients may go without. Priority review can mean the difference between getting your insulin on time or going without for weeks.

What Happens When an Application Gets Rejected?

Even if you submit a complete application, it doesn’t mean approval is guaranteed. In 2022, 31.7% of original ANDAs got a Complete Response Letter (CRL)-basically, a “not quite” notice. The most common reason? Problems with chemistry, manufacturing, or controls (CMC). That’s a fancy way of saying the drug wasn’t made consistently enough to be safe.

Each CRL adds about 4.2 months to the review clock. And most applications need 1.7 review cycles before they’re approved. That means even if you start with priority review, you could end up with a 12-month timeline if you get stuck in revisions.

That’s why more companies are using the FDA’s pre-submission meetings. In 2020, only 41% of sponsors had these meetings. By 2023, that number jumped to 63%. These meetings let companies ask the FDA, “Will this work?” before spending hundreds of thousands on testing. It’s not free-it costs time and money-but it cuts down on costly rejections.

What’s Changing in 2024 and Beyond?

The FDA isn’t standing still. In 2023, they launched a pilot program to help with complex generics-things like inhalers, topical creams, and extended-release pills. These are harder to copy because the way the drug is delivered matters as much as the chemical itself. Right now, only 9.7% of these complex generics get approved, even though they make up nearly 20% of pending applications.

And in Q3 2024, the FDA plans to roll out AI tools to help speed up reviews for simpler applications. In internal tests, AI reduced review times by 18.7%. That might not sound like much, but for a company waiting to launch, even a few weeks matters.

By 2026, analysts estimate these changes could cut the average time to generic approval by 4.3 months. That could save the U.S. healthcare system $18.7 billion a year.

Industry Reactions: Real Voices

Not everyone is thrilled. On Reddit, a senior regulatory affairs manager wrote: “The domestic manufacturing requirement is noble but unrealistic for complex generics where 92% of specialized excipients still come from Europe and Asia.”

But another voice on the same thread said: “We’ve already shifted two product lines to our Pennsylvania facility. The 2-month review acceleration could mean $120M in additional revenue for our key cardiovascular product.”

That’s the split. Some see the new rules as a barrier. Others see them as a competitive edge.

Big players like Teva, Sandoz, and Hikma are already investing in U.S.-based bioequivalence labs. Contract research firms like Covance and PPD are reporting 35% growth in U.S. testing capacity year-over-year. The race is on.

What Should Generic Drug Companies Do Now?

If you’re applying for FDA approval, here’s what you need to do:

• Check if your drug qualifies as a first generic or is on the shortage list. If yes, aim for priority review.
• If you’re not sure, talk to the FDA early. Use the pre-submission meeting program.
• Start mapping your supply chain. Can you source your API from the U.S.? Do you have a U.S. manufacturing site? If not, plan for it now.
• Don’t assume your application is ready. CMC issues are the #1 reason for delays. Test, test, test.

The FDA isn’t trying to make things harder. It’s trying to make the system more reliable-for patients, for manufacturers, and for the country’s health security. The rules have changed. The clock is ticking. And the next generic drug to hit the market? It might be yours-if you play the game right.