I recently led an initiative to communicate more proactively and frequently with the leaders of the FDA about issues specifically related to improving the agency’s focus on innovative biomedical and therapeutic technologies.
At San Diego’s Biocom, where I am CEO, we believe that both industry and regulators can benefit from an atmosphere of open communication and trust. Ultimately, we all benefit from an improved track record of product review and approval, compliance, and regulatory policy development. Over the course of this initiative, we learned that while there is nothing as important to product approval as a well-developed data package, it helps to follow a few basic tenets for working with FDA.
—Approach the FDA with a positive mindset. It is critical to abandon any notion that the relationship must be confrontational, controversial, or competitive (as in “us” versus “them”) and accept the concept that both parties can win. I have found in working at the policy level that approaching the relationship with a willingness to work objectively to establish a dialogue is fundamental.
—Establish multiple lines of communications with the FDA. Start at the reviewer level to focus on specific issues, then expand by engaging in broader discussions at the senior executive level. This can be accomplished by participating in forums, such as the roundtable sessions that Biocom has held between members and FDA leadership, including Commissioner Dr. Peggy Hamburg, Deputy Commissioner Dr. Steven Spielberg, and Director Dr. Jeff Shuren of the Center for Devices and Radiological Health (CDRH). I have found that FDA leadership has been more than willing to engage in discussions to gain a better perspective on companies and their products, as well as to obtain input in the policy arena.
—Make sure everyone is on the same page. Ensure that issues of concern and points you want to discuss are clearly understood and agreed upon by you and the FDA’s representatives. Successful relationships with the FDA and other regulatory agencies can be attributed above all to both parties having a clear, well-defined understanding of requirements, commitments, issues, and steps to resolve a disagreement.
—Be consistent in your strategy while accepting the importance of flexibility—within reason. The key to this point is the importance of time, cost, and reasonableness. It is important to acknowledge positive interaction and give credit where credit is due, while providing criticism in a constructive manner when criticism is warranted. All of this must be executed within the central focus of the strategy, which is to obtain a result—whether it is review of a 501k or a new drug submission, or resolution of a compliance issue.
—Keep the conversation going. Communicate with FDA on a relatively frequent basis at every level. At Biocom, we continuously strive to build better relationships with FDA leadership to take advantage of the FDA’s goal of advancing positive patient outcomes. The FDA periodically engages in the development of new initiatives to advance this goal, and the opportunities that we have created for direct interaction between both sides affords us the ability to be participants in the process. On the individual company level, it is insufficient to simply await communication from the FDA side; the key to success is to make yourself and your company known to the reviewer.
While these recommendations can go a long way toward a positive outcome with the FDA, they must be qualified by the understanding that the relationship with the FDA typically involves complex scientific issues and can be frustrating for reasons that transcend this discussion. Nevertheless, I believe that these points serve to present a foundation upon which any successful working relationship must be constructed.
