Good ... But Not Good Enough!

Several years ago, I wrote a blog column (published elsewhere) that asked the question: "Why do some people hate FDA?" It drew a lot of comments. Readers wanted to know: what makes haters different from agency critics? After all, aren’t all of us critical of the agency at some point, even the commissioner?The haters -- and there are some on both the left and the right -- are distinguished by their inability to say anything good about the agency. I am on my 10th FDA commissioner. Bad decisions were made during each of their tenures and they all experienced days when nothing seemed to work the way it should. Meantime, hundreds of drugs and devices have been approved without subsequent mishap. Our food supply is vulnerable because of globalization, yet it is the safest in the world.Those who dislike or hate FDA focus almost exclusively on those bad decisions and on the agency’s most difficult days. In their minds, that is the FDA. They don’t see the rest of the days where things went well: public health improved, patients received new FDA-approved therapies and more than 300 million Americans ate food without an outbreak of food-borne disease.One of the things that Alliance members have in common is that we are not FDA haters. We have diverse opinions about the FDA, many criticisms, and lots of ideas about how the agency can do a better job. Many of our members have positions on FDA that call for changes and improvements. Sometime, in order to be heard, they express those ideas in sharp dissent, with calls for radical reform and even a little anger. These are mainstream by comparison and don’t qualify as signs of dislike or hatred toward the agency. Even they will admit that on any given day the agency will do far more things right than they do wrong. Some amount of dissent keeps everyone sharp.What prompts me to write about this today? A recent opinion poll, in which 58% of respondents had a favorable view of the FDA. Our tendency is to think that’s great -- especially when FDA came out ahead of other regulatory agencies.But is it really good enough? I would say, “No.” Thirty-one percent of the respondents had an unfavorable view of the agency, of which half had a very unfavorable view. That’s way too many. Some of the unfavorable views I attribute to the haters, their demonic view of the agency and the negative energies they encourage. But I think it is also a reflection of the need to tell the FDA’s story better -- to publicly explain what the agency does and why its role is essential to the nation’s public health and well-being. The agency is far from perfect, but we all have a stake in their achieving better numbers the next time a survey is taken.Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.