“During SupplySide West, one of my first introductions to the industry was attending a presentation by Daniel Fabricant, CEO and executive director of NPA. Fabricant explained ‘…the will from regulatory agencies to use injunction tools when they find GMP violations is something that is not going away’.
Many companies, especially in the industry, overlook or even fear regulatory agencies and worry that simply starting a conversation might put them on the regulatory bodies’ radar, and not in a good way.
While I am new to the industry, I am seasoned in the arena of crisis communication and issues management, having managed more than 50 crises and hundreds of issues. Regardless of the company, organization or industry, there are a few basic principles that are fundamental in effective crisis communication planning and response. In particular, this industry has very specialized needs when it comes to communicating with and regarding regulatory bodies.
Prioritize
One of the biggest mistakes an organization can make after being slapped with an injunction or warning by the FDA or FTC is to think that their primary focus should be responding to the media. Rather, an important first step is determining and prioritizing all key audiences, with the regulatory agency being at or near the top of the list.
It is imperative for companies to put aside their fears and work to effectively cooperate with the regulatory agency. The importance of this lesson is reflected in a situation I managed a few years ago. A company engaged me literally in the midst of a crisis. A few hours prior, the organization had experienced a serious industrial incident and because of unique circumstances and timing it had become the focus of several prominent “breaking news” stories.
While working to assist in managing response to a crush of media trucks, live shots and interview requests, I asked the client about plans for communicating with various audiences, including notifying regulatory agencies. Because the company’s interaction with regulatory agencies had been minimal – one or two times over its more than two decades in business – coupled with the nature of the incident and the fact they didn’t even know who to contact, the company incorrectly believed notification wasn’t necessary.
The incident occurred in the late evening and by early morning a regulatory agency had not only dispatched investigators but had also issued a press release announcing their investigation and that the company was in violation of failing to notify them. This added fuel to the media fire and greatly exacerbated an already challenging situation.
In the days that followed, the regulatory agency positioned itself as “the source” and leveraged the incident as a platform to communicate its “hero role” in cracking down on violators, making an example out of the company in the process. Additionally, an agency spokesperson speculated on areas outside of their expertise and investigation, which further compounded the situation.
After the dust cleared, the company was cited with a minimal fine for failure to notify and for an unrelated technical infraction. Despite the agency not finding any substantial violations surrounding the incident, the company’s reputation had been tarnished, and it took a significant effort over several months and even years to recover.
Communicate internally
There were several lessons learned from the incident and its aftermath. In addition to failing to notify regulatory agencies, the company initially did not communicate with its own employees and lacked a media protocol or policy (informing staff regarding authorized spokespersons and instructing them on how to delegate media inquiries). As a result, an employee, who was trying to be helpful, spoke with one of the first reporters to arrive onsite and provided incorrect information that mischaracterized details of the incident and created significant confusion and challenges.
Many of the mistakes of this incident could have been avoided or the impact significantly minimized had the company invested in crisis communication planning, training, regular check-ups (at least twice-annual plan updates) and even simulations to test planning and response.
As part of the planning and check-up process, those in the industry should give special consideration to how and when to communicate with regulatory agencies. Fabricant stressed the importance of starting a proactive conversation with the regulators, especially on a district level. This is where a company needs to establish a dialogue, find out who is at the district level and start regular communication.
It’s important to know what is happening in Washington D.C., but as I learned from my clients in the industrial incident, local regulators were the catalyst for not only negative messaging, but for controlling the conversation.
As I spoke to companies on the show floor at SSW, many had sentiments that a crisis plan is just there to address the media, or it is to be used only in catastrophic situations. The point is, a GMP violation can turn into a catastrophic situation at any moment, and it does not seem that the regulatory bodies are easing up any time soon.
The cliché ‘an ounce of prevention is worth a pound of cure’ rings especially true. The difference in the outcomes for individuals and organizations that are forward thinking and prepared versus those who aren’t can be the difference between the success and failure of a company.”
Chris Thomas is President of Intrepid. He is a nationally recognized communication professional with 20 years of experience developing and executing hundreds of campaigns with an emphasis on crisis communication.
Chris has managed more than 100 crises including corporate fraud, identity theft, protests, industrial accidents, murders, kidnappings, executive compensation issues, downsizings and numerous investigative reports. He is a contributing author to the “Crisis Management Guidebook” published by PR News and is called on regularly by the media to provide insight and commentary regarding crisis communication.