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Building a Productive Relationship with the FDA: Beyond the Science

Building a Productive Relationship with the FDA’ was originally published by Pharmaceutical Online. Click here to read the original article.  Halloran Principal Consultant, Michelle Rose, also contributed to this article.

Whether your relationship with the FDA starts with pre-IND feedback (see Part 1 of this three-part series) or simply with an IND submission (see Part 2) itself, these early interactions will likely form the basis for a long (and hopefully happy) marriage.  After all, this liaison could very well last beyond submission and initial approval of a marketing application to including additional trials relevant to the drug’s development and labeling.  As there is no manual available for building an effective and collegial relationship with the FDA, this article offers helpful tips to assist sponsors in establishing and maintaining this critical union.

At the end of the day (or several years), sponsors and the FDA ideally work collaboratively during the drug development process, having a shared public health goal of making safe, effective, and high-quality drugs available to the American public as quickly as possible.

Start Off On The Right Foot
Here are some best practices to keep in mind (and mention to your team) as you begin those engagements with the agency:

Keeping the above in mind, you’ll be on track to establishing and maintaining a positive, mutually respectful relationship with the FDA.

Know The Roles And Rules
In December 2015, the FDA released draft guidance called Best Practices for Communication Between IND Sponsors and FDA During Drug Development.  This document sheds some light on the FDA’s philosophy regarding communication with sponsors, as it is so critical to a strong relationship.

First, the FDA defines the roles and responsibilities of both the sponsor and the agency:

The draft guidance states that the FDA believes that scientific and regulatory recommendations provided during drug development meetings with sponsors may result in more efficient and robust development programs. This philosophy is articulated in 21 CFR 312.47, 21 CFR 312.82, FDA’s meetings guidances, CDER’s Manuals of Policies and Procedures (MAPPs), and CBER’s Standard Operating Policy and Procedures (SOPPs). Sponsors can request meetings with the FDA at any time during drug development, and the FDA strongly encourages sponsors to request critical milestone meetings.  The information you can obtain from these types of meetings can truly shape your entire development program, even shaving off some time if it is agreed that certain studies might not be necessary.  Further, these periodic engagements with the FDA aid in fostering a relationship that sponsors continue to build upon as development progresses.

Here’s one final thought to ponder: Behind every successful marketing application is an effective relationship involving many representatives from the pharmaceutical industry as well as the FDA.  While the fate of the application is undoubtedly tethered to the science behind it, how effectively the application winds its way through the regulatory labyrinth is hugely linked to the working relationship that exists between the sponsor and the FDA.   Ineffective communication and a poorly fostered relationship can ultimately delay approval and can translate into millions in lost sales.