FDA has a reputation for being tough on dissent, whether it comes from employees or regulated companies. It is often alleged that FDA employees with contrary views are re-assigned, marginalized or ousted. Within the regulated industries, there is a widespread belief that arguing with FDA has adverse consequences for a company.

Whatever the truth has been in the past, FDA is trying to develop an institutional cultural that welcomes and accepts dissent from employees, industry and other stakeholders. It is difficult, even messy, to do this. Yet, FDA’s reputation and authority rests on showing that it listened to all competing views–without unreasonably slowing the decisionmaking process.

Forming a consensus and “speaking with one voice” are logical and sensible for FDA, but not an accurate reflection of what happens when well-trained, analytically-oriented people gather to make a decision. FDA can acknowledge this….or feed the perception that senior managers impose their biases on subordinates. I believe this is the exception and not the rule, but there is no denying the perception.

FDA Matters sees three needed changes at FDA:

• Incorporate dissent into the decisionmaking process,
  
• Resist the urge to ignore, punish or marginalize dissent, and
  
• Tolerate the ambiguity of decisions made in the face of dissent.
  

Incorporate dissent. FDA makes decisions in an increasingly complex scientific environment in which there are bound to be disagreements. For example, reviewers focused on the risk-benefit of a medical product are often at odds with reviewers whose focus is safety.

Near the end of April, the Center for Devices and Radiological Health (CDRH) announced that FDA presentations at CDRH advisory committee meetings will reflect the diversity of views from the review group, rather than a unified, consensus analysis. In time, I predict this approach will be expanded to other advisory committees and a broad array of FDA activities. Dissenting views from other stakeholders, including industry, will also be increasingly visible as part of new processes.

Resist the urge to ignore, punish or marginalize dissent. This is incredibly hard to do and probably requires the most cultural change. We are programmed to exclude people who persistently disagree and who can’t imagine themselves as being wrong. But sometimes they are right…and sometimes their concerns lead to better conclusions or better reasoning to support a decision. And the agency can hardly claim they have incorporated dissent if a consequence is exclusion or punishment.

Tolerate the ambiguity of decisions made in the face of dissent. One fear of empowering dissent is that every decision will look suspect, regardless of what decision was made. Visible dissent also invites Congress, media, advocacy groups and industry to second-guess the agency. At the moment, Congress seems particularly inclined to question the agency’s decisions.

How does FDA adjust to the challenge of showing it listens to dissenting views, knowing it is inviting those disputes to be re-argued in multiple forums? One answer is that the agency must continue to work hard on increasing trust in the agency’s decisionmaking. This is already a priority for Commissioner Hamburg.

It is inevitable that FDA will need to become more open to dissent. Thoughtful structures need to be put in place to channel it and not suppress it. The risk is that the agency will become less efficient as it spends more time on debating decisions….and less on making and implementing them. For those patients and companies looking for progress against disease, this is of the greatest concern. The supposed trade-off of dissent and efficiency needs to be confronted and thoughtfully resolved by FDA leadership.

Steven

This column has focused more on internal dissent within FDA, but industry also feels pressure not to question FDA. I often hear companies say they pushed hard on an issue and found the agency more open and willing to listen than they expected. On the other hand, two products were approved this year only after the companies persisted in the face of negative FDA decisions.

The announcement of new procedures at CDRH, including the change from unified, consensus presentations, is at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm209791.htm.

This entry was posted on Sunday, May 9th, 2010 at 9:28 pm and is filed under Drug Approval and Access, FDA Accountability and Transparency, FDA Leadership. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.