According to an article by Zachary Brennan, RAPS, the Government Accountability Office (GAO) issued a report in December 2015 that in review of the Document Archiving, Reporting and Regulatory Tracking System (DARRTS), the FDA has not formally tracked 144 issues relating to Fast Track and Breakthrough Therapy drugs. It was reported that the backlog needs to be tackled for drug safety oversight. The report further details that FDA does not yet have a full comprehensive plan in place with defined goals and timelines to address these problems identified.
Brennan’s article states FDA response is “First, the agency says that all drugs must meet the same statutory standards for safety and effectiveness, regardless of their expedited status. Second, drugs authorized through expedited pathways do not necessarily require different postmarket studies than other drugs approved through standard pathways, and finally, FDA says it’s working to address “challenges related to administrative tracking of its postmarket safety work.”
So, sometimes the best plans need revisions and the GAO study recommends FDA develop a comprehensive plan to address issues identified. Let’s keep moving forward on a safe and accelerated process for drug development to get therapies in the hands of the patients who have no other options. Pearl Pathways is on track to help you accelerate your drug development process in a safe, guided manner. Let’s work together, contact us.