Decisions, decisions

US Food and Drug Administration (FDA) decisions and other regulatory decisions, similar to other communications issues management events, are like wild fires: they can either be deliberate or unplanned events.  Your ability as a company to respond and guide appropriate communications will determine whether the wild fire is a managed burn or an uncontrollable fire tearing through thousands of acres of your property.  Your property, in this case, could be your corporate or product reputation, or your investors and their capital.

Communicators or corporate leaders often attempt to control an FDA or regulatory decision that is outside their authority. They believe if they can 'quarterback it,' or take the communications role upon themselves, that they can turn any decision into an opportunity for their company. However, in order to compensate for the lack of full control over an FDA or regulatory decision, they may try to over-communicate and place more of a spotlight on themselves than on the milestone that they are trying to manage. This may cause more harm than good.

Communicators or corporate leaders need to understand the appropriate time and place for leadership communications, especially when an FDA or regulatory decision is involved. In some cases, it is best to have the communications lead serve as the one point of contact for the milestone event. The communicator must be armed with sufficient knowledge to be able to respond appropriately to reporters and key stakeholder audiences (see diagram, below). Likewise, a corporate leader may have the knowledge, but without proper coaching, his knowledge, previous statements and position within the company can very easily be turned against him by a savvy reporter. Proper planning and scenario role-playing with all parties involved will establish the appropriate roles and responsibilities within each individual company.

Key audiences for FDA and regulatory decisions

Before the event
As in any major expected communications event such as an FDA or regulatory decision, there is no replacement for proper scenario planning and practice well in advance of the regulatory action. When we attended grammar school, most of us were taught how to react to a fire by conducting very simple fire drills. In advance of a regulatory event, a drill is a wise investment of time that is well worth its price. The communicator should also:

• Be prepared for the event and have a detailed issues management plan
• Understand the scope or the landscape and how an event (FDA or regulatory decision) can impact the company
• Recognize the potential impact of the decision to key stakeholders (company, physicians, patients, investors, advocacy groups)
• Establish the communications infrastructure needed for the response
• Possess the ability to assess the event on the ground in order to properly respond appropriately and with timelines.

During the event
Similar to a general who plans a military engagement, or a fire commander who is intending to battle a major fire, you have to leverage what was learned during the planning period and be able to synthesize properly the information in order to make critical and positive decisions to keep your organization moving forward toward a proper solution. Like a general or fire commander, you should:

• Know your FDA or regulatory decision landscape and apply communications resources appropriately
• Create communications that appropriately share the necessary amount of information that a reporter will need, but not over-disclose proprietary information
• Be as transparent with your information as possible
• Provide a guide path or clear direction on any or potential future updates or communications to appropriate audiences.

Following the event
Honest strategists are willing to learn and evolve, review critical milestone events and analyze whether their actions and reactions were appropriate, or in hindsight could have been adjusted. The difference between a 'table top' exercise on an FDA or regulatory decision and the experience with an actual event is significant. While you can engage in extensive contingency planning, nothing takes the place of the real thing. More importantly, nothing replaces honest self-evaluation of the situation that occurred, the actions taken and the end results – both positive and negative. It is critical to ask yourself what you would change for the future. Following an FDA or regulatory decision your review should include: 

• Monitor communications before, during and after and collect and analyze any news
• Be prepared to respond to coverage (if appropriate)
• Re-assess your plan in its present form. Was it well executed? Did it have the desired outcome?
• If needed, take the opportunity to fine-tune your plan and any advance tools or communications protocols in preparation of the next event.

Vigilance following an FDA or regulatory decision event is important since there will be a strong desire for communicators or corporate leaders to attempt to 'set the record straight,' or add commentary. As with wildfires, 'mop-up' exercises help determine if the wildfire is completely out or whether it will re-ignite. It is best not to provide any additional fodder or fuel to a fire that is already successfully managed. A properly designed issues management plan is a crucial element to successful communications before, during and following an FDA or regulatory decision event.

The author
Carey Pilato Senior Vice President, LaVoie Group, can be reached at cpilato@lavoiegroup.com or +1 (978) 745-4242