In 2002, when I was the FDA's associate commissioner for external relations, Dr. Janet Woodcock came in to my office and she was not smiling. The director of the Center for Drug Evaluation and Research at the time, she waved a draft of a new drug approval press release at me and asked, "How is anybody supposed to understand this? It's written for scientists!"

I felt her pain. My answer to Dr. Woodcock was that the press office had written a much more consumer-friendly document, but that the release had, quite literally, been doctored when sent to the Center for Drug Evaluation and Research for review. Rather than focusing on the important public health message intrinsic in the new drug approval, the career science staff insisted on putting in more science. "Well," she said, "that's not going to happen anymore." And that was the beginning of a beautiful relationship.

What that story demonstrates—and why I never tire of retelling it—is that communications at the FDA is a perfect example of the maxim, "It's not what we say that matters—it's what our target audience remembers." All the science in the world—precise and important as it may be—is not going to help the average consumer understand why a new drug is important, why it was approved, or even what it does.

While much has changed over the past 25 years, one of the immutables has been that the FDA tries to communicate important health messages but has neither the resources nor the aggressive attitudes necessary to consistently do it well. A big part of the problem is that not only have communications tools, modalities, and strategies changed rather dramatically over the past quarter century, but people and society have changed too. Perhaps the most important change is that today the consumer is significantly more empowered when it comes to healthcare. But what's changed at the FDA?

Today, the FDA's various constituencies ranges from medical professionals to patient advocates, elected officials, disease organizations, academics, and researchers. They no longer accept the previous FDA communications philosophy of "We'll tell you what you need to know" otherwise known as "We talk. You listen." In this respect, the need for an FDA communications revolution is not dissimilar to the many positive changes that have taken place over the last 25 years in the physician-patient relationship. Can you imagine what a doctor in 1981 would have thought if a patient had come in and actually wanted to discuss the range of therapeutic options available for a given medical condition?

Empowered Patients
The FDA, without even knowing it, has helped empower patients. By approving new drugs within existing therapeutic categories while at the same time dealing with pharmaceutical industry communications initiatives, the agency has helped to empower American health care consumers by allowing them to have choices and learn about their options. It's fair to say that FDA knew precisely what it was doing in this respect.

The bad news is that the area where the FDA of 1981 is most similar to today's agency is in the arena of risk communications. With so many new drugs on the market and so many more people needing them, the FDA must step up to the plate and realize that doing a better job in risk communications is not only a top priority for the agency's political survival—but a marvelous opportunity to promote the public health. The Vioxx imbroglio, in this respect, was a missed opportunity for the agency to step up to the plate. Relying on "Dear Doctor" letters and questionable risk management programs does not cut the mustard in 2006.

In 2005, the FDA held a hearing on how the agency can do a better job on risk communications. Joe Cranston, of the American Medical Association, had the most specific and useful recommendations relative to helping doctors receive and communicate risk information. He called for the agency to finalize the new physician labeling rule (since accomplished), work more closely with specialist organizations on relevant risk communications issues, use post-market surveillance information for data mining opportunities, and increase funding for post-market surveillance for same. He also made the point that the big issue for doctors is time. How can the FDA help physicians prioritize and deliver relevant risk information to their patients?

Forward Motion
There is hope. Senior management at the agency does understand and appreciate both the urgency and the opportunity. Witness the long-awaited and hugely significant new physician labeling rule and the savvy personnel choice of Paul Seligman as CDER's new Associate Center Director for Safety Policy and Communication in the Center for Drug Evaluation and Research. Two superb examples of significant forward motion in 21st century risk communications.

But if change is frightening (and it is), then communicating change is formidably so, and doing so from a sinecure in the Federal bureaucracy is well nigh impossible.

Or is it?

When I arrived at the FDA, one of my first meetings was with the entire staff of the Office of Public Affairs. I held up a telephone and reminded them that the unit came with a set of buttons at no additional charge. In other words, don't wait for people to call you—pick up the phone and make the call. Be proactive. Spread the gospel. Use the bully pulpit. Drive the agenda.

Or be driven by it.

The Journal of Life Sciences welcomes commentaries. To submit a piece, contact Daniel S. Levine at daniel.levine@blsmg.com or 415-591-5449.