How Many Drugs Does the FDA Approve Every Year? An Analysis of Recent Trends

In 2024, the FDA's Center for Drug Evaluation and Research (CDER) approved 50 novel drugs, contributing to a decade-long average of about 47 novel approvals annually. The specific number of therapies fluctuates each year due to numerous influencing factors, which directly impacts the number of drugs the FDA approves every year.

Quick Summary

The annual number of novel drug approvals by the FDA is not static, averaging approximately 47 therapies per year over the last decade due to various industry and regulatory factors.

Key Points

• Annual Fluctuation: The number of drugs the FDA approves each year varies, with recent trends showing an average of around 47 novel therapies annually between 2015 and 2024.

• Recent Peak Performance: Recent years have seen particularly high numbers, with 59 novel drug approvals in 2018 and 55 in 2023.

• Impact of Expedited Pathways: FDA programs like Priority Review, Breakthrough Therapy, and Accelerated Approval help expedite the review of promising therapies for serious conditions, influencing the annual approval rate.

• Focus on Rare Diseases: Incentives for developing orphan drugs for rare diseases are a significant driver, with over half of the novel drugs approved in 2024 targeting such conditions.

• Shift in Therapeutic Landscape: The composition of approved drugs is evolving, with a notable increase in biologics and targeted therapies compared to traditional small-molecule drugs.

• Beyond Novel Drugs: The annual count of novel drugs does not include other important approvals, such as generics or expansions for previously approved drugs.

Understanding the Fluctuations in FDA Drug Approvals

When asking how many drugs does the FDA approve every year, the answer is never a single, consistent number. The figure fluctuates annually, reflecting the complex and dynamic nature of the pharmaceutical industry and the regulatory process. The FDA, through its centers like CDER and CBER, evaluates new therapies for safety and efficacy. Multiple factors influence the final number of novel drug approvals each year.

The Breakdown of Recent FDA Approval Data

Analyzing recent data reveals fluctuations in annual novel drug approvals, which include New Molecular Entities (NMEs) and new therapeutic biologics. From 2015-2024, CDER novel drug approvals ranged from 22 in 2016 to a high of 59 in 2018, with 55 in 2023 and 50 in 2024. A comprehensive table of US-FDA novel drug approvals from 2013-2022 can be found {Link: A Comprehensive Review of US-FDA Novel Drug Approvals from 2013-2022: An Observational Study https://biomedpharmajournal.org/vol18no3/a-comprehensive-review-of-us-fda-novel-drug-approvals-from-2013-2022-an-observational-study/}.

Factors That Influence the Annual Tally

Annual FDA approvals are influenced by factors such as the volume of applications and the use of expedited review programs for serious conditions. The Orphan Drug Act also provides incentives, with orphan drugs often being a significant portion of approvals; in 2024, 52% of novel drug approvals were for orphan diseases. Industry trends like shifts towards oncology and biologics and corporate activities like mergers also affect the pipeline and approvals.

Comparing Annual Approvals by Key Characteristics

The composition of approvals is also important, with trends in 'first-in-class' drugs and orphan designations providing insight into innovation. More detailed data on annual approvals by characteristics can be found {Link: A Comprehensive Review of US-FDA Novel Drug Approvals from 2013-2022: An Observational Study https://biomedpharmajournal.org/vol18no3/a-comprehensive-review-of-us-fda-novel-drug-approvals-from-2013-2022-an-observational-study/}.

The Multi-Stage Path to Approval

Achieving FDA approval requires a lengthy, multi-stage development and review process, often taking over a decade. This process is crucial because the annual approval number represents only those few that successfully navigate it.

1. Discovery and Preclinical Research: Initial identification and testing in labs and animals.
2. Investigational New Drug (IND) Application: Requesting permission for human testing.
3. Clinical Research: Testing in humans to assess safety, dosage, and efficacy.
4. New Drug Application (NDA): Submitting all data for FDA review.
5. FDA Review and Approval: Evaluating data and approving if benefits outweigh risks.
6. Post-Market Safety Monitoring: Ongoing surveillance after approval.

The Shift in Therapy Types

There's a trend towards approving non-traditional therapies, including biologics and peptide-based drugs (TIDES), alongside small molecules. This shift favors targeted and complex treatments for conditions like oncology and rare diseases.

Visit the FDA website for more information on novel drug approvals

Conclusion

The annual number of FDA drug approvals varies, averaging about 47 novel therapies from 2015 to 2024. This number is influenced by factors like application volume, expedited review use, and focus on rare diseases and biologics. The rigorous FDA process ensures approved drugs meet safety and efficacy standards.

Frequently Asked Questions

Does the annual number of FDA-approved drugs include generics?

No, the commonly cited annual figure for novel drug approvals does not include generic drugs. The FDA has a separate, abbreviated approval process (Abbreviated New Drug Application or ANDA) for generics that do not require new clinical trials.

What is a 'novel drug' in the context of FDA approvals?

A 'novel drug' refers to a drug product containing an active ingredient that has never been approved or marketed in the U.S. before. This includes both New Molecular Entities (NMEs) and new therapeutic biologics.

Why does the number of annual FDA approvals fluctuate?

The annual number of FDA approvals can fluctuate due to several factors, including the number and quality of applications submitted by manufacturers, regulatory changes, market trends, and the use of expedited review pathways.

What are the expedited approval pathways the FDA uses?

The FDA uses several expedited programs for serious conditions with unmet needs, including Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval. These can speed up the development and review timeline.

Which therapeutic areas see the most FDA drug approvals?

Over recent years, the FDA has approved a high number of drugs in therapeutic areas such as oncology (cancer), infectious diseases, and for rare (orphan) diseases, reflecting industry focus and regulatory incentives.

Does the FDA test the drugs itself?

No, the FDA does not conduct its own testing of drugs. Instead, it reviews the extensive data submitted by pharmaceutical companies from their own laboratory studies and human clinical trials to determine a drug's safety and effectiveness.

What happens after a drug receives FDA approval?

After approval, the FDA continues to monitor the drug's safety through post-market surveillance. Companies are required to report new information, and the FDA can take regulatory action if necessary to protect public health.