FDA Open For Suggestions For Improving Communication With IND Sponsors

The FDA published an announcement on the Register, seeking input from the public on how the agency might communicate better with pharma companies developing new drugs. For the next sixty days, the agency will collect information from “interested parties” with the hopes of compiling the suggestions into a new guidance.

A renewed commitment to communication is part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA), which promises additional resources to the agency in return for specific reforms.

One of those reforms is an overhaul of communication channels between the agency and those drug makers which are submitting investigational new drug (IND) applications. The FDA hopes that by improving communication the agency might facilitate innovation and speed new and improved treatments (both chemical and biologic) to clinical trial.

The FDA published a comprehensive list of performance goals they plan to pursue between 2013-2017. According to the report, the findings from this survey, which seeks the input from Academic institutions, regulated industry experts, and other interested organizations, will help train employees at the Center for Drug Evaluation and Research (CDER).

The FDA is seeking feedback on: how best to establish clear expectations between both parties; which are the most appropriate means of communication (teleconferencing, email, etc.) and how often such communications should take place; the scope of regulatory involvement of appointed review teams; and ways to speed the turnaround on inquiries put to the agency by drug developers.

The FDA hopes that by clearing up some of the red tape drug developers have encountered in the past, innovative drug makers will experience fewer delays and avoid mishaps in compliance which could set back their clinical progress.

Overall, the FDA expects the guidance to reflect the FDA’s core philosophy which is that “timely interactive communication with sponsors during drug development is a core Agency activity to help achieve the Agency’s mission to facilitate the conduct of efficient and effective drug development programs, which can enhance public health by making new safe and effective drugs available to the American public in a timely manner.”

The FDA plans to consider all suggestions received between now and December 29. The FDA plans to publish the guidance by the end of 2015.