Priority vs Standard Review: How FDA Prioritizes Generic Drug Applications

When a generic drug hits the market, it’s not just luck-it’s the result of a carefully managed race. The U.S. Food and Drug Administration (FDA) doesn’t treat every generic drug application the same. Some get reviewed in 8 months. Others wait 10 months. That two-month difference can mean millions in revenue, faster access for patients, or even avoiding a drug shortage. But how does the FDA decide which applications get priority?

What’s the difference between priority and standard review?

The FDA uses two tracks for reviewing generic drug applications, known as Abbreviated New Drug Applications (ANDAs). Standard review gives applicants a 10-month timeline to get approval. Priority review cuts that down to 8 months. It sounds simple, but the impact is huge.

Under the Generic Drug User Fee Amendments (GDUFA) III, which took effect in October 2022 and runs through 2027, these timelines are locked in. The clock starts ticking the moment the FDA accepts your application as complete. If your paperwork is missing key data, the FDA sends a Refuse-to-Receive letter. You’ll have to pay another $164,880 filing fee and start over. That’s why getting it right the first time matters more than ever.

Standard review covers most generic drugs. If your product isn’t the first version available after a brand-name drug’s patent expires, and it’s not addressing a shortage, you’re in the standard lane. Priority review, on the other hand, is reserved for specific cases: first generics, drugs in short supply, or those that offer a meaningful improvement over existing options.

Who qualifies for priority review?

Not every company can claim priority. The FDA has clear rules. The biggest category is first generics-the first company to submit a complete ANDA after a brand-name drug’s patents and exclusivity expire. These get priority because they’re the gateway to lower prices. In 2022, 92.7% of first generics earned 180 days of market exclusivity, meaning no other generic could compete during that time. That exclusivity window is worth hundreds of millions.

The second major reason is drug shortages. If the FDA determines a generic version is needed to prevent or resolve a shortage of a critical medication-like antibiotics, insulin, or chemotherapy drugs-it can fast-track the application. The agency tracks shortages through Section 506C of the Federal Food, Drug, and Cosmetic Act, and responds quickly when a life-saving drug is running low.

There’s also a third, less common path: medically important advances. If a generic version uses a better formulation-say, a more stable tablet, a less irritating injection, or a modified-release version that improves patient adherence-it might qualify. These are rare, but they happen. The FDA doesn’t reward minor changes. It looks for real clinical or safety benefits.

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 security. The goal? To bring more generic drug manufacturing back to the United States.

To qualify, applicants must prove three things: their bioequivalence studies were done in the U.S., their finished dosage forms (the actual pills or injections) are made in the U.S., and their active pharmaceutical ingredients (APIs) come from U.S.-based suppliers. This is a big deal. Right now, 80% of APIs are made overseas, mostly in India and China. The pandemic exposed how fragile that supply chain is.

Companies that meet all three criteria get priority review automatically. That means their 8-month clock starts sooner, and they’re less likely to get stuck in review delays. The FDA estimates this pilot will help 45 to 60 applications per year. But here’s the catch: only 12.3% of generic drug makers currently meet all three requirements, according to FDA facility data.

That’s why big players like Teva, Sandoz, and Hikma are rushing to build U.S.-based testing labs and manufacturing lines. Contract research organizations like PPD and Covance are seeing a 35% jump in U.S.-based bioequivalence studies year over year. It’s expensive, but the payoff is worth it. One executive on Reddit said shifting two products to their Pennsylvania facility could bring $120 million in extra revenue-just from getting approved two months earlier.

Why do so many applications get rejected?

Getting approved isn’t just about timing. It’s about quality. In 2022, nearly one-third (31.7%) of ANDAs received at least one Complete Response Letter (CRL), meaning the FDA found problems that had to be fixed before approval. The biggest culprit? Chemistry, manufacturing, and controls (CMC) issues-47.2% of all delays.

That includes things like inconsistent tablet hardness, unstable packaging, or impurities in the API. Even small deviations can trigger a CRL. The average ANDA goes through 1.7 review cycles before approval. Each cycle adds about 4.2 months to the timeline. That’s why more companies are turning to pre-submission meetings with the FDA.

In 2020, only 41% of sponsors requested these early discussions. By 2023, that number jumped to 63%. Those who do get more first-cycle approvals-up from 24.1% to 38.7%. It’s like getting feedback before submitting your final exam. You fix the mistakes early, and you don’t fail.

What about complex generics?

Not all drugs are created equal. Simple pills? Easy to copy. Inhalers, topical creams, injectables with complex delivery systems? Not so much. These are called complex generics, and they make up 18.3% of pending ANDAs but only 9.7% of approvals. Why? Because proving bioequivalence is harder. The FDA can’t just compare blood levels-they have to test how the drug behaves in the body, how it’s absorbed, how it’s released.

To help, the FDA started the Complex Generic Drug Product Pilot Program in January 2023. It gives sponsors early scientific advice on how to design their studies. Companies that use this program report fewer CRLs and faster approvals. It’s a smart move-complex generics are where the next wave of savings will come from. If you can make a generic version of an expensive inhaler, you’re not just saving money-you’re changing lives.

What’s next for FDA generic reviews?

The FDA is getting smarter. By Q3 2024, it plans to roll out AI-assisted tools to help review straightforward ANDAs faster. In internal tests, these tools reduced review times by 18.7%. That means simpler applications-like generic aspirin or metformin-could get approved even quicker than 8 months.

Industry analysts predict that by 2026, these changes will cut the average time to generic approval by 4.3 months. That could save the U.S. healthcare system $18.7 billion a year. The FDA also wants to increase the share of U.S.-made generic drugs from 28% to 40% within five years. That’s ambitious, but the incentives are clear: if you make it here, you get reviewed faster.

Meanwhile, the number of ANDA submissions keeps rising. The FDA expects 1,275 applications in FY 2024-a 12.5% jump. Priority reviews are growing even faster. In 2020, only 21.1% of approvals were priority. By 2022, that number was 28.4%. And it’s still climbing.

What does this mean for patients and providers?

It means more affordable drugs, faster. When a first generic enters the market, brand-name drug prices often drop by 50% or more within months. A 2022 report from IQVIA showed that generics filled 88.6% of all prescriptions in the U.S.-but cost only 15.3% of total spending. That’s the power of competition.

When a drug shortage is avoided because a generic arrived on time, it’s not just a regulatory win-it’s a health win. Patients don’t have to switch treatments. Hospitals don’t have to ration. Doctors don’t have to guess.

The system isn’t perfect. Delays still happen. Complex drugs still lag. But the FDA’s tools-priority review, the manufacturing pilot, pre-submission meetings, and AI-are making it better. For generic manufacturers, the message is clear: plan ahead, invest in U.S. capacity, and get expert advice early. For patients, the result is simple: more access, lower costs, and fewer shortages.