It was tough calling winners and losers after last week’s 2-day marathon review of the diabetes medication Avandia by a U.S. Food and Drug Administration advisory committee. The final vote made clear that the drug was far from exonerated, but the complex nature of the recommendation (a majority voted to keep the drug on the market, with restrictions) handed critics of Avandia something less than a victory.
Still, there was no doubt that the FDA ended up in the “winner” column. The vote means that the agency has great latitude and scientific cover to shape the future of Avandia, and the FDA’s handling of the meeting won plaudits from both panelists (Tufts cardiologist Marvin Konstam said the meeting was proof that the FDA was working well: “I don’t think it’s been at all broken“) and the press (the Boston Herald said the FDA “deserves praise for letting staff members publicly debate the issues”.)
I don’t want to suggest that the success of the FDA was due to public relations, not science, but FDA did make five PR moves that helped them successful manage the agency’s approach to the meeting:
1. FDA got the data out early: The agency allowed the press to get a look at all of the materials that the panelists reviewer earlier than usual — accompanied by access to top FDA brass — which helped make the 700-odd pages of analysis more manageable. It would be tough to claim that the agency’s viewpoint was simple or that the FDA’s staff spoke with one voice, but the media had plenty of time to work it all out.
2. FDA brought out the big guns: I’ve attended somewhere nearing 100 panel meetings, and I’m not sure I’ve ever seen a cameo by the commissioner of the FDA. But Peggy Hamburg took the unusual step of addressing the panelists on the first day, making clear that the FDA expected a discussion around science, not hype or politics. That had a profound impact, and it made clear where the FDA stood on the process. As the RPM Report’s Ramsey Baghdadi put it: “Tone was perfect. Big time players make big time plays in big time games.”
3. FDA accepted contrarian viewpoints: Depending on your math, FDA officials had at least 5 different views on Avandia that were presented at the meeting. This kind of cacophony is counter to the keep-it-simple advice that we typically give when comes to messaging, but, in this case, it underscored a deeper FDA point: the agency was committed to scientific discourse. Period. And that was the message came through loud and clear in all coverage.
4. FDA respected the needs of the press: On the morning that the Avandia panel was to begin, the FDA was scheduled to release briefing documents for another high-profile meeting later in the week. Rather than hew to the usual schedule, which would have meant dropping the documents in the middle of key presentations on Avandia, the briefing information was disseminated in the pre-dawn hours. While brutal for night owls, the move recognized that the FDA press couldn’t do two things at once, and do them well.
5. FDA let the chips fall where they may: The other effect of not pushing a single unified view was that the agency didn’t appear to be influencing the panel in one way or another. That, in turn, allowed them to avoid one of the great perils of working too hard to disseminate a viewpoint: they never appeared controlling and never risked losing credibility as a result. Knowing how much control to give up is a subtle, dangerous game, but the FDA played it perfectly last week.
I’m hoping to incorporate a few of these lessons into my approach in the months and years to come. While some of the techniques should be standard practice, such as getting the press information quickly (#1) or respecting the complexity of the news cycle(#4), other FDA moves are certainty worth exploring, even if they carry some risk. Can we use top executives more strategically in roles they don’t usual fill (#2)? Can we endure contradictory messages if they help our audiences reach a deeper truth (#3)? The answers aren’t simple. But, then again, next practices rarely are.
(Disclosure: WCG has worked with GlaxoSmithKline on Avandia in the past, though we were not involved in this advisory committee in any way.)
It was tough calling winners and losers after last week’s 2-day marathon review of the diabetes medication Avandia by a U.S. Food and Drug Administration advisory committee. The final vote made clear that the drug was far from exonerated, but the complex nature of the recommendation (a majority voted to keep the drug on the market, with restrictions) handed critics of Avandia something less than a victory.
Still, there was no doubt that the FDA ended up in the “winner” column. The vote means that the agency has great latitude and scientific cover to shape the future of Avandia, and the FDA’s handling of the meeting won plaudits from both panelists (Tufts cardiologist Marvin Konstam said the meeting was proof that the FDA was working well. “I don’t think it’s been at all broken,” he said) and the press (the Boston Herald said the FDA “deserves praise for letting staff members publicly debate the issues”.)
I don’t want to suggest that the success of the FDA was due to public relations, not science, but FDA did make five PR moves that helped them successful manage the agency’s approach to the meeting:
1. FDA got the data out early: The agency allowed the press to get a look at all of the materials that the panelists reviewer earlier than usual — accompanied by access to top FDA brass — which helped make the 700-odd pages of analysis more manageable. It would be tough to claim that the agency’s viewpoint was simple or that the FDA’s staff spoke with one voice, but the media had plenty of time to work it all out.
2. FDA brought out the big guns: I’ve attended somewhere nearing 100 panel meetings, and I’m not sure I’ve ever seen a cameo by the commissioner of the FDA. But Peggy Hamburg took the unusual step of addressing the panelists on the first day, making clear that the FDA expected a discussion around science, not hype or politics. That had a profound impact, and it made clear where the FDA stood on the process. As RPM Report’s Ramsey Baghdadi put it: “Tone was perfect. Big time players make big time plays in big time games.” http://twitter.com/Ramsey_Baghdadi/status/18433140128
3. FDA accepted contrarian viewpoints: Depending on your math, FDA officials had at least 5 different views on Avandia that were presented at the meeting. This kind of cacophony is counter to the keep-it-simple advice that we typically give when comes to messaging, but, in this case, it underscored a deeper FDA point: the agency was committed to scientific discourse. Period. And that was the message came through loud and clear in all coverage.
4. FDA respected the needs of the press: On the morning that the Avandia panel was to begin, the FDA was scheduled to release briefing documents for another high-profile meeting later in the week. Rather than hew to the usual schedule, which would have meant dropping the documents in the middle of key presentations on Avandia. Instead, the briefing information was disseminated in the pre-dawn hours. While brutal for night owls, the move recognized that the FDA press couldn’t do two things at once, and do it well.
5. FDA let the chips fall where they may: The other effect of not pushing a single unified view was that the agency didn’t appear to be influencing the panel in one way or another. That, in turn, allowed them to avoid one of the great perils of working too hard to disseminate a viewpoint: they never appeared controlling and never risked losing credibility as a result. Knowing how much control to give up is a subtle, dangerous game, but the FDA played it perfectly last week.
I’m hoping to incorporate a few of these lessons into my approach in the months and years to come. While some of the techniques should be standard practice, such as getting the press information quickly (#1) or respecting the complexity of the news cycle(#4), other FDA moves are certainty worth exploring, even if they carry some risk. Can we use top executives more strategically in roles they don’t usual fill (#2)? Can we endure contradictory messages if they help our audiences reach a deeper truth (#3)? The answers aren’t simple. But, then again, next practices rarely are.
(Disclosure: WCG has worked with GlaxoSmithKline on Avandia in the past, though we were not involved in this advisory committee in any way.)
By:
Brian ReidBrian Reid is a director at WCG in the product group, where he specializes in media. He is a former journalist who believes content really is king.
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