The driver's seat is the best place to be in public debates

"No comment" is always a missed opportunity. That's how I summed up my communications strategy for the FDA when I spoke to PRWeek during my tenure as the agency's associate commissioner for external relations.

"No comment" is always a missed opportunity. That's how I summed up my communications strategy for the FDA when I spoke to PRWeek during my tenure as the agency's associate commissioner for external relations.

And as recent events have proven, if you don't drive events, you'll be run over by them.

The difference between responding to events and driving the debate is enormous. When you drive the debate - no matter how difficult or uncomfortable - you ensure a fair fight. When you respond, you are at the mercy of someone else's agenda. Driving the agenda is hard. It is higher risk. It requires greater skill. It accepts that the facts alone will not set you free. And that is hard to accept at the FDA - an agency staffed by scientists.

The FDA deals with tough public-health issues every day, each of them with crucial significance to the American public. At the FDA, it is never "just another day at the office." While there, I dealt with mad cow disease, DTC advertising issues, silicone breast implants, over-the-counter contraception, the banning of ephedra, bioterrorism, drug importation, pharmacogenomics, ways to speed generic drugs to market safely and effectively, animal cloning, counterfeiting, obesity, expanded access policies, SARS, and qualified health claims - to name only a few. And each of these issues was, from a communications standpoint, dealt with aggressively. The FDA drove the agenda. It was about fixing the problem rather than fixing the blame.

Today, it's about fixing the blame and finding a villain. And the best villain is one who won't speak up aggressively in his own defense. As with defendants in a trial, "no comment" means guilty. Today, unfortunately, the 10,000 people who work long hours at the FDA on the toughest issues - at government pay - are seen as defendants. And in the eyes of the press, politicians, and the public, they are guilty until proven innocent.

Consider the current controversy over drug safety. If you've recently arrived from another planet and picked up a paper within the last few months or so, you'd think the US population is at imminent threat of dropping dead from unsafe, untested, unmonitored pharmaceuticals. The accusations that the FDA has a cavalier attitude toward safety are untrue, unfair, unjust, and just plain revolting. It was only last year that Nobel Laureate Milton Friedman said that the FDA was "obsessed" with safety. And that "obsession" is rightly viewed as a badge of honor. At the FDA, science rules and safety is mission-critical.

Unfortunately, recent FDA-bashing is not about making things better, it's about making headlines, making money, settling old scores, and generally pursuing various agendas - none of which are designed to "make drugs safer."

Truth be told, the circus surrounding the Vioxx recall demonstrates three key things. The first is that the system works, contrary to C-SPAN bloviating and various and sundry pilings-on. The second is that the general public (and, it seems, some of our elected officials) doesn't understand how the FDA works. And third, the twin terms of "safety" and "risk" must be more clearly communicated to both physicians and patients (otherwise known as "consumers").

What role should the FDA play in the debate that, today, must be both scientific and message-driven? The answer is that it must not only be both regulator and interlocutor with industry, but, even more important, a more strident practitioner of bully pulpit communications. Silence is not always golden.

As consumers become more empowered, the FDA can no longer issue white papers and press releases and deem the communications task complete. More targeted public education campaigns are required. The FDA must drive the debate or be driven by demagogues with agendas other than that of the public health. The FDA must move from, strictly speaking, protecting the nation's health to protecting and advancing its health. This requires a strategy with actionable, aggressive tactics. Otherwise it's just rhetoric.

That's both a daunting problem and a fabulous opportunity. How to better communicate what "safe" means is an opening for the FDA to drive the agenda. It's a meaty communications challenge the FDA must accept. If handled responsibly, creatively, and aggressively, it puts the FDA back in control of the agenda. And when it comes to protecting and advancing the public health, we want the FDA in the driver's seat.

  • Peter Pitts is SVP for global health affairs at MS&L, a senior fellow for healthcare studies at the Pacific Research Institute, and a former associate commissioner for external affairs at the FDA.

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