The FDA is accelerating and accelerating approval for drug development

The U.S. Food and Drug Administration's (FDA) Fast Track and Accelerated Approval pathways can expedite the review of new drugs.

This article examines these pathways and outlines how they impact drug development and related industries, including healthcare and pharmaceuticals.

Photo credit: Design Space InPharmatics LLC

FDA Fast Track Designation: Accelerating the drug development process

The FDA Modernization Act of 1997 established fast track designation to expedite the development and review of new drugs to address unmet medical needs and treat serious diseases.

The FDA Fast Track process involves regular interactions with the FDA, including the opportunity for early and ongoing review processes and clinical trial conduct.

This approach allows for ongoing dialogue between the regulator and drug developers. Accelerating the review process enables timely advice and implementation of adjustments that significantly shorten development time.

A key benefit of the FDA Fast Track designation is that it speeds up the drug approval process. Early and continuous communication helps companies identify and proactively close any data gaps, thereby minimizing the risk of delays and inefficiencies.

Drugs approved for FDA's Fast Track may also be eligible for accelerated approval and priority review, further streamlining the regulatory process.

Bridging the gap to clinical benefit

The accelerated approval pathway allows for earlier approval of drugs for serious diseases if they offer a significant advantage over current treatments and therapies.

This pathway also allows for the approval of drugs that address an important treatment gap by using surrogate endpoints to predict clinical benefit. In these cases, drugs can be approved while confirmatory studies are still ongoing.

The accelerated approval pathway has brought to market a number of breakthrough therapies in oncology and infectious diseases.

Adopting surrogate endpoints as a basis for approval demonstrates that the FDA recognizes the importance of balancing benefits and risks in cases where waiting for traditional endpoints could cause significant harm to patients.

Impact of FDA's Fast Track and Accelerated Approval Processes on Drug Development and Healthcare

The FDA's Fast Track and Accelerated Approval pathways have significant impacts across the healthcare landscape, beyond drug development.

pharmaceutical company

Pharmaceutical companies can benefit from FDA Fast Track and Accelerated Approval pathways by reducing the cost and time required to bring new therapies to market.

This is key to improving efficiency across the industry and encouraging continued investment in innovative research targeting difficult-to-treat or otherwise complex diseases.

Healthcare

Through the FDA Fast Track and Accelerated Approval pathways, patients with serious illnesses can benefit from earlier access to potentially life-saving treatments. These pathways represent regulatory recognition that new therapies are urgently needed in areas with limited or non-existent treatment options.

Note: Drug developers are responsible for ensuring post-marketing commitments are met. In the event of accelerated approval, confirmatory studies are essential to confirm that the drug continues to provide the expected clinical benefit.

Challenges and Controversies

The FDA's Fast Track and Accelerated Approval pathways have had an undeniable positive impact on patient outcomes, but these have not been without controversy. A number of concerns were raised including:

• Reliance on surrogate endpoints could put patients at risk if approved drugs with clinical benefit are not fully established.
• Failure by companies to promptly conduct confirmatory studies after approval could jeopardize the strength of the evidence supporting the continued use of the new drugs.

To address these concerns, the FDA has tightened regulations and improved its oversight of confirmatory studies. Additional emphasis was placed on verifying clinical benefit through rigorous post-marketing studies.

A balance must be struck between rapid access to potentially life-saving medicines and the importance of ensuring their safety and effectiveness once approved. This represents a dynamic and ongoing challenge for the pharmaceutical industry and the FDA.

Summary

The FDA Fast Track and Accelerated Approval pathways have revolutionized the drug development landscape and given hope to patients with serious diseases by enabling innovative therapies to come to market more quickly.

Patients can receive the medical support they need in their daily lives, while FDA Fast Track and Accelerated Approval pathways improve the efficiency of drug development and review processes for pharmaceutical companies.

However, a careful balance must be struck and ongoing dialogue between the broader healthcare community, drug developers and regulators must be maintained. as the pharmaceutical industry continues to evolve.

This dialogue will be critical to optimizing the FDA Fast Track and Accelerated Approval pathways to ensure they serve the best interests of patients in every case.

DS InPharmatics specializes in leveraging the benefits of FDA Fast Track, Accelerated Approval and other expedited processes to help customers bring breakthrough therapies to patients more quickly.

The company's team can help ensure a drug development process meets the highest regulatory compliance standards and maximizes the potential of expedited pathways such as FDA Fast Track and Accelerated Approval.

References and further reading

1. Fast track. FDA. Published 1^st April 2018. Accessed February 8, 2024.
2. Guidelines for Accelerated Industry Programs for Serious Diseases – Drugs and Biologics. FDA. Published May 2014. Accessed 8^Th February 2024.
3. Kim C, Prasad V. Cancer drugs approved based on a surrogate endpoint and subsequent overall survival: An analysis of 5 years of US Food and Drug Administration approvals. JAMA Intern Med. 2015;175(12):1992-1994. doi: 10.1001/jamainternmed.2015.5868.

Acknowledgments

Made from materials originally written by Meranda Parascandola of Design Space InPharmatics LLC.

About Design Space InPharmatics LLC

DSI provides regulatory, technical and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cell and gene therapy products.

Since 2007, we have been offering our customers innovative strategies and high-quality work products to improve product development, approval and marketing presence.

Whether we are advocating CMC strategy, leading CMC operations, or developing CMC submission content that represents the best interests of emerging biotechnology, we focus on the critical CMC issues and develop programs that advance development.

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