The FDA's image is changing along with the approval process.Since commissioner Mark McClellan took the helm last November, the Food and Drug Administration (FDA) has started to look very different. With any luck, and delivery on McClellan's part, before long the government agency will become unrecognizable from how it has traditionally been viewed. Most prominently reported in the media has been McClellan's commitment to accelerating the FDA's new-drug application process, which has notoriously been seen as inefficient and, at times, deceiving. In order to receive user fees from drug companies, which usually amount to millions of dollars, the FDA is required to review drugs within a certain amount of time. The agency has often been criticized, however, for extending the allotted time by requesting additional data from drug makers right before their drugs were supposed to be approved or rejected. Because the clock stops while a drug company is scrambling to get the requested information, reported application-review times often seemed better than they actually were. Just last month at the Biotechnology Industry Conference in Washington, DC, the new commissioner offered signs of hope. McClellan vowed to reduce the median review time for drugs by 10% over the next five years. On average, this means the review time could go from 18 months to 16 months, while drugs for diseases with no treatment - a.k.a. priority drugs - that are generally reviewed in six months could have their passage reduced by several weeks. If achieved, McClellan estimated that the approval process for each new drug would cost $12.8 million less. The approval process for biotech products, which was the focus of the June meeting, is the same as that for pharmaceuticals. What The Wall Street Journal calls "Dr. McClellan's willingness to challenge the tyranny of the FDA statisticians and their gold standard of evidence" has been warmly received by patients and drug makers, both slowly but surely developing a more favorable view of the government agency. Changing the message Similarly, McClellan's seemingly more effective notions on drug-approval processes, along with some of the other changes he has implemented since being in charge, have also resulted in a new approach to communications at the FDA. As Peter Pitts, the agency's associate commissioner for external relations, puts it, "The message is not just that these drugs are getting approved, but it's a question of why they are being approved." In April, the same month that Pitts took over the top communications post at the FDA, McClellan announced a new strategy for the agency, which centers on five goals: ensuring a strong FDA; efficient risk management; patient and consumer safety; better consumer information; and counter-terrorism. Pitts, who reports directly to the commissioner, says all communications efforts are being designed to promote the new five-point strategy. Pitts developed an acronym to ensure all outgoing messages reflect McClellan's plan. SELF stands for Sound science, Ensuring safety, Lowering costs, and Fostering innovation, and is "a quick test" for his staff. Pitts encourages his team to always ask themselves if they are touching on the four points when speaking to an audience. "Particularly with the general consumer audience," Pitts explains, "it is important for them to understand the FDA so they feel safe using the products we regulate." The creation of Drugs@FDA - a consumer-focused interface on the FDA's website expected to launch in October - is currently being used as a platform for communicating McClellan's fourth goal, which is to provide better consumer information. The interface will be a searchable database of all FDA-approved drugs. Users will be able to review approval history, manufacturer information, indications, potential side effects, and generic alternatives for each drug. Pitts calls Drugs@ FDA an "important part" of his department's proactive outreach. To support McClellan's vision in consumer and other areas, Pitts has fostered a more aggressive approach to communications, which he says functions "less like a government agency and more like a marketing agency." He explains, "Traditionally, communications at the FDA has been more reactive than proactive because there is such a great deal of incoming interest. Now we're going out and telling our story the way we want it told." Pitts, who oversees the FDA's office of public affairs, office of the ombudsman, office of special health issues, and advisory committees, checks in weekly with his staff to find out how many outgoing calls they made. He says, "We cannot be told what to promote. If we wait for reporters to call us, they have essentially already written the story. By calling them, we're driving the communications agenda." Pitts encourages his staff to view the media as "more of a conduit than a constituency," adding, "If we treat reporters as colleagues, we will both be able to get our messages out more effectively." The increasingly collaborative approach to communications, according to Pitts, will also result in the PR agencies working for drug companies viewing the FDA as more of a partner than an unknown entity. "Where we normally would have just been one added paragraph in a story, we are now becoming a major player. This benefits everyone involved in formulating messages about a company," says Pitts. He concludes, "The more alliances and friendships we can build, the more viable we will be as a message driver." Building the FDA brand Prior to joining the FDA, Pitts was a managing partner at Wired World, an Indianapolis-based PR firm. He has an extensive background in marketing, unlike his predecessor, Linda Skladany, who had more experience in government work and lobbying. Replacing Skladany - who was with the agency for less than one year - with Pitts suggested that McClellan wanted to foster an increased focus on building the FDA's brand. At the time of Pitts' appointment, The Pink Sheet commented, "Marketing experience appears to have been an important selling point for Pitts, as McClellan seeks to create an FDA 'brand.' As the commissioner noted in his memo, Pitts 'is also a branding expert, and we've discussed the need to enhance and strengthen the FDA brand.'" When describing how the FDA is using its upcoming centennial year, 2006, to build the agency's brand, Pitts jokes about him and his team giving themselves "marketing steroid injections." "We don't view the centennial as a birthday party," he says. "It is an excuse to further explain what we are doing to our constituencies. We see it as an opportunity to talk about where we are going in the next 100 years, rather than where we've been for the last 100." In addition to the changes related to drug-approval processes, Pitts reports enhanced communications efforts in the area of biotechnology. "In order to maximize the potential of biotech, the FDA needs to be an integral player. This requires us to learn a lot of new science," he says. Enforcement of consequences for corporate wrongdoings are also receiving increased attention under the reign of McClellan and Pitts. Already, the agency has revamped the warning letter it sends to companies under investigation. Pitts describes the new letter as having "sharper teeth to send the message that we mean business." He adds, "Without actively promoting enforcement, it is impossible to garner public trust." The obesity epidemic and preventing production of counterfeit drugs are also high on Pitts' priority list, as they are both issues the commissioner intends to speak out about. Commissioner McClellan's insistence on implementing change at the FDA has imposed a demanding schedule on the agency's chief communicator and his staff. But it is a responsibility that Pitts, whose wife has forbidden him from checking his Blackberry past 10pm, gladly accepts. "It's easy to just sit back and have as your goal cleaning out your inbox by the end of the day," he says, "but we need to be advocates as well as regulators." Proudly, he adds, "When a message comes directly from the FDA, there's a certain level of respect. That's a very nice place to start."