Priority vs Standard Review: How FDA Prioritizes Generic Drug Applications

The U.S. Food and Drug Administration 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 entering the market two months faster, which often translates to hundreds of millions in extra revenue. For patients, it means cheaper drugs hit shelves sooner. But how does the FDA decide who gets which path? And why does it matter so much?

What’s the difference between priority and standard review?

Under the Generic Drug User Fee Amendments (GDUFA) III, which took effect in October 2022, the FDA sets clear timelines for reviewing generic drug applications called ANDAs (Abbreviated New Drug Applications). Standard review gives the agency 10 months to complete its evaluation. Priority review cuts that down to 8 months. That two-month gap might seem small, but in the generic drug world, it’s everything.

The FDA doesn’t assign priority review randomly. It’s earned. Only specific types of applications qualify. These include:

• First generics-the very first version of a brand-name drug approved after its patents expire
• Drugs listed on the FDA’s drug shortage list
• Complex generics that offer a meaningful improvement over existing versions

For example, if a drug like metformin loses patent protection and your company is the first to submit a complete application, you automatically qualify for priority review. That gives you a head start before other companies even get in line.

How does the FDA decide who gets priority review?

The process starts before the application even reaches the review team. Every ANDA goes through a 74-day filing review. If the application is missing key data-like bioequivalence studies, manufacturing details, or labeling info-it gets a Refuse-to-Receive (RTR) letter. That means you pay the $164,880 filing fee again and start over.

Once it’s accepted, the FDA’s Office of Generic Drugs (OGD) digs into the science. They check:

• Chemistry and manufacturing controls (CMC)
• Bioequivalence data (does your generic behave like the brand?)
• Labeling accuracy
• Patent and exclusivity status (using the Orange Book database)

First generics are the easiest to qualify for priority review. The FDA tracks patent expirations closely. In 2022, 92.7% of first generics received 180 days of market exclusivity-a legal shield against competitors. That’s why companies race to be first. One company can capture 80% of the market in the first year.

The new U.S. manufacturing priority pilot

In October 2023, the FDA launched something new: the ANDA Prioritization Pilot Program. This isn’t just about speed-it’s about supply chains.

The pilot gives priority review to ANDAs that meet three strict criteria:

1. Bioequivalence testing done in the U.S.
2. Finished dosage forms manufactured in the U.S.
3. Active pharmaceutical ingredients (APIs) sourced entirely from U.S. suppliers

Why? Because the pandemic exposed how fragile the global drug supply chain is. In 2021, the FDA found that 80% of APIs were made overseas. Antibiotics, antivirals, insulin-most of it came from China, India, or Europe. When borders closed, shortages hit hard.

The FDA wants to change that. They’re offering faster approval to companies that bring manufacturing back. Commissioner Robert Califf said the goal is to raise the share of U.S.-made generic drugs from 28% to 40% within five years.

But here’s the catch: only 12.3% of generic drug sponsors currently meet all three requirements, according to FDA facility data. Many rely on European excipients or Asian APIs. Switching suppliers isn’t easy. It takes years to requalify a new factory. For complex products like inhalers or injectables, it’s nearly impossible without major investment.

Who’s winning-and who’s struggling?

The numbers tell a clear story. In 2020, just 21.1% of approved ANDAs got priority review. By 2022, that jumped to 28.4%. That’s a 37% increase in just two years. Companies like Teva, Sandoz, and Hikma are investing heavily. IQVIA reported that major generic manufacturers increased U.S.-based bioequivalence testing by 22% year-over-year in 2023.

One company shifted two product lines to its Pennsylvania facility. They estimated the two-month head start could bring $120 million in extra revenue for a single cardiovascular drug.

But not everyone is on board. In online forums, some regulatory professionals say the rules are unrealistic. One manager on Reddit wrote: “92% of our specialized excipients come from Europe. We can’t just switch overnight.”

The FDA knows this. That’s why they also launched the Complex Generic Drug Product Pilot Program in January 2023. It gives early scientific advice to companies working on tricky products like topical creams, inhalers, and extended-release pills. These make up 18.3% of pending applications but only 9.7% of approvals because they’re so hard to get right.

Why delays still happen-and how to avoid them

Even with priority review, most applications don’t get approved on the first try. In 2022, 31.7% of ANDAs received at least one Complete Response Letter (CRL). The biggest reason? Chemistry, manufacturing, and controls (CMC) issues. Nearly half of all delays came from problems with how the drug was made-impurities, stability data, or inconsistent batch production.

The average ANDA takes 1.7 review cycles to get approved. Each cycle adds about 4.2 months to the timeline. That means even a priority review can stretch to 14 months if it’s sent back.

The fix? Pre-submission meetings. In 2020, only 41% of companies met with the FDA before filing. By 2023, that number jumped to 63%. Companies that do this see their first-cycle approval rate rise from 24% to nearly 39%. It’s not free-it costs time and money-but it saves far more in the long run.

The bigger picture: cost, access, and the future

Generic drugs make up 88.6% of all prescriptions in the U.S. but only 15.3% of total drug spending. In 2022, the market hit $128.7 billion in sales. That’s why every month counts. The average time from patent expiration to first generic approval is still 2.7 years-mostly because of lawsuits and regulatory delays.

The FDA’s new tools are starting to help. They’re testing AI to speed up reviews of simple applications. In internal trials, AI cut review times by 18.7%. By 2026, experts predict these changes could shave 4.3 months off average approval times. That could save the U.S. healthcare system $18.7 billion a year.

The message is clear: speed matters. But so does quality. The FDA isn’t just trying to get drugs to market faster-they’re trying to make sure those drugs are safe, reliable, and made where we can trust them.