FDA’s Expedited Pathways

The ability to bring some drugs to market faster can mean life or death for some patients. The U.S. Food and Drug Administration (FDA) has created several pathways that could expedite the approval processes for certain drugs. Many pharmaceutical consulting firms will advise their drug developers of such pathways. The FDA will review all drugs as efficiently as possible, however with the intake of many new applications everyday, it prolongs the FDA’s approval process. FDA determined it was necessary to create pathways in order to expedite therapies for serious or life-threatening diseases.

This special consideration allows the pharmaceutical developers to participate in four different pathways.These pathways are; Priority Review, Accelerated Approval, Fast Track, and Breakthrough Therapy. Each pathway is designed to expedite the development and availability of new drugs. The four pathways improve FDA efficiency by utilizing different selection criteria and focusing on different aspects of the drug development and approval process. Pharmaceutical consulting firms working with sponsors that are considering submitting a Biologics License Application (BLA) or New Drug Application (NDA) will review the specifics of their drug to see if it meets the criteria for the Priority Review pathway.

Priority Review reduces the review period to six months, while the normal review period for NDA’s and BLA’s is ten months. Prior to submitting an Investigational New Drug (IND) application, pharmaceutical companies should contact a pharmaceutical consulting firm to verify if their drug would qualify for the Fast Track pathway. Biologics and pharmaceutical companies may request the Fast Track pathway prior to their BLA or NDA submission. Drugs may qualify for the Fast Track program if no other therapy exists for the condition it intends to treat, or it provides a greater benefit over the existing treatments. The benefits of the Fast Track process are that sponsors will receive additional opportunities to meet with the FDA to discuss items such as study design, approval requirements, and identification of the most efficient pathway through drug development and review. Another benefit is the possibility to obtain access to rolling review. Rolling review allows sponsors to submit portions of their marketing application for review prior to submitting a complete application.

Breakthrough Therapy is a great pathway for drugs that demonstrate early clinical evidence of considerable improvement over existing treatments. Although requesting the Breakthrough Therapy process can be done as early as IND application, pharmaceutical consulting firms will advise that the FDA prefers to receive the request prior to the end of the phase II meeting. The difference between Fast Track and Breakthrough Therapy is that the latter places a greater significance on early meetings and coordination with knowledgeable FDA staff. When early clinical results are promising, drugs in the Breakthrough Pathway may be able to bypass portions of the standard FDA review process without the compromise of safety and efficacy standards. The Accelerated Approval is intended for drug therapies with long-term primary outcomes that are hard to measure correctly in trials.

Long-term primary outcomes such as increased survival or decreased morbidity may instead be approved based on surrogate endpoints since they may be measured more efficiently and are more likely to estimate the clinical benefit. Pharmaceutical consulting firms or sponsors should contact the FDA during development to assess the Accelerated Approval pathway.The FDA requires sponsors to verify a drug’s efficacy in post-market trials. Most of the pathways can be used in conjunction with others as long it meets the drug criteria. Drug developers should contact an experienced pharmaceutical consulting firm to discover whether or not their product meets the eligibility requirements and when designation is required in the process of each of FDA’s expedited pathways.

Author Information

Christina Sanchez Miller, MPH has over 20 years of management, biologics, quality assurance and research experience in the medical field. She is a published author in scientific books, papers and has presented at several international conferences. Christina has developed medical applications in the biologics field. Her experience includes operations and consulting in FDA Adverse Event Reporting, FDA Product Deviation Reporting, FDA 483s, cGTPs, infection control, certified ISO Class 5, 7, 8 development and maintenance, QIC and auditing.

BRG is a global scientific & regulatory consulting firm with extensive experience in the strategic development of drug products, biologics, medical devices, combination products and in FDA regulatory affairs. BRG is a pharmaceutical consulting firm focusing on NDA regulatory services, 510k services, and IND consulting services.  The opinions and statements in this blog are those of the authors and do not necessarily reflect those of BRG. This blog is based on personal experience and reviews of information publicly available or identified in other database searches.

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