BulletProofBlog the blog on crisis communications

Each week, Bulletproof Blog™ features exclusive interviews with thought leaders on issues of critical importance to companies and countries. This week, as the Food and Drug Administration (FDA) enters the final phase of its new Transparency Initiative, we interview Robert Maples, a Senior Legislative Advisor at the law firm of Dickstein Shapiro LLP, about the FDA’s effort to make the agency – and the companies it regulates – more open to the general public.

Mr. Maples has counseled a number of clients and companies on complex regulatory and public policy matters. Currently, he leads the Research Accountability Project (RAP), which aims to identify, disclose, and prevent socially-biased agency-based government research. A leading authority on food, drug and tobacco issues, and editor of the e-newsletter FDATracker®, Mr. Maples shared his thoughts with Bulletproof™:

Tell us about the FDA’s Transparency Initiative and its intended impact on the companies it regulates. Are there regulatory changes in the offing that food and pharmaceutical companies should be preparing for now?

Robert Maples: On his first full day, President Obama issued an Executive Order on transparency and the FDA’s Transparency Initiative arose in response to this call for open government. The FDA formed a Transparency Task Force; built FDA Basics; held two public forums for input; and is currently reviewing approximately 1,400 comments to a public docket.

I‘ll also disclose a secret: Sources tell me that FDA has done all the work to date on a very modest budget and their effort is being watched as a potential model for other federal agency transparency efforts.

I don’t foresee any great regulatory changes emerging from this effort. There may be continuing debate and potential further restrictions and regulation of corporate social media utilization and the transparency of what is disclosed. As Justice Brandeis so famously said, “Sunlight is the best disinfectant” – and, for the most part, what is to be “disinfected” has yet to be seen.

What tangible benefits await food and pharmaceutical companies that take a more transparent approach when communicating with key marketplace and government stakeholder groups?

Robert Maples: I had an old friend in the public relations business whose advice in crisis situations was to “tell the truth and tell it often.” I don’t think any readers doubt that we have a new FDA on the watch and the message is clear: Police thyself and do it well or a warning letter is in your future. Further, FDA has signaled an interest in “stepped-up” criminal enforcement, which probably keeps many a CEO up at night.

Companies that police themselves and walk the white line will find enormous benefit by not being the next front page story in the Wall Street Journal. Transparency is a significant element in effective reputation management – and today, reputation management is really, really important to FDA-regulated companies.

Furthermore, in the wake of a year that was as tough on the consumer product industry as I can remember, I think that consumers want a little more connection to the brands they buy. Information and communication will reinforce the brand connection with the consumers and empower them to be confident in their buying decisions.

Are there ways that food and pharmaceutical companies can leverage the power of online communications to enhance transparency?

Robert Maples: Yes, many have used online communication to provide consumers additional information regarding products, adverse reactions, and precautions. The Web provides a very cost-effective and open forum to provide expansive information that can’t fit on a box, label, or bottle. Of course, FDA is watching the Web as well, so my advice to companies is to communicate with an eye toward compliance.

What’s next at the FDA? Are there issues emerging on the horizon that the companies under its purview need to know about?

Robert Maples: Almost all aspects of old existing authorities are seeing many new initiatives.  The Senate is poised to pass food safety modernization legislation and the food companies ought to be thinking about how they can shape its implementation. The Drug industry faces multiple challenges – from generics to nanotechnology and beyond. And, then, there is tobacco. The FDA is literally building a new enterprise to regulate the $80 billion U.S. tobacco market with 370 new personnel next year.

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Larry Smith is Senior Vice President of Levick Strategic Communications, the nation's top crisis communications firm, and a contributing author to Bulletproof Blog. Connect with Levick on Twitter: @Levick.