FDA Announces Final Guidance On Expedited Drug Review

The Food and Drug Administration (FDA) has released final guidance on its expedited drug review programs. The guidance covers the four programs that the FDA developed and implemented to review drugs more quickly.

Janet Woodcock, the Director of FDA’s Center for Drug Evaluation and Research, wrote in the FDA Voice that these programs have helped to make the U.S. first in the world for approving drugs. She wrote, “Just last year, three-quarters of the new drugs approved by FDA were approved in the United States before any other country.”

Expedited Drug Review Final Guidance

The FDA distributed a draft version of the guidance, seeking input from stakeholders in the industry and in academia. After the comment period, the FDA issued the final guidance. Interested parties should review the document to see whether novel candidates are eligible. The FDA makes note of several distinctions to guide sponsors. For instance, a chart explains that expedited reviews are for “serious” conditions but the Accelerated Approval is for drugs for serious conditions AND that have a meaningful advantage over existing therapeutics.

Besides the qualifying criteria, the guidance advises when to submit a request, timelines for FDA responses, and additional considerations. The guidance states that drugs granted accelerated approval have to meet the same evidentiary standards as those granted traditional approval, and the agency explains that criteria in its guidance.

The FDA says that all marketing materials must be submitted to the FDA within 120 days following marketing approval. Drug sponsors must also be prepared for post-marketing studies. Of note to interested parties, is the information in the guidance relating to the conditions in which the FDA will revoke expedited review approval.

Expedited Review Programs

Currently, the FDA has four expedited review programs, covered in the guidance. Fast track designation gives the sponsor more frequent meetings and communications with FDA. Accelerated Approval bases approval on tests or biomarkers, rather than endpoints. Priority review commits the agency to acting on an application within six months and not the usual ten months. The Breakthrough Therapy Designation provides Fast Track designation benefits plus intensive guidance on an efficient drug development program. The FDA has received 186 requests for the Breakthrough Therapy Designation, approved 48 applications, and approved six drugs as of May 2014. The FDA says that almost half of the drugs approved in 2013, used one of the expedited review programs.