A Look at FDA’s Transparency

When Ed Koch was mayor of New York, he'd often ask a crowd "How am I doin?"  If you are in a position of authority, it isn't a bad question to ask every now and then, as long as you are going to listen to the answer.

FDA has been all about transparency under its new leadership, and that has been a good thing.  I'm not sure what metrics the agency is using, however, to measure success in their efforts.  So I thought it might be a good time to provide some insights that might, in part, answer the question "How am I doin?"

First, last year in June, the FDA launched a Transparency Task Force.  The Task Force held two public meetings in 2009 and posted the materials regarding the meeting.  There have been no meetings in 2010.  Has momentum lost steam or is mission accomplished?  According to the Mission Statement, the Task Force was to issue a written report to the commissioner with findings and recommendations, "approximately six months" after being convened. It was issued in May 2010.  I had to do a Google search to find it though, it wasn't located on the Transparency Task Force landing page.  

The agency has made some great strides in transparency development.  One of the most visible has been the launch of FDA Basics.  FDA Basics provides tutorials and explanations, in written formats, by Webinars, and through videos, that explain some of the fundamentals about how and why the FDA does things.  It is well organized in categories, allows for consumers to sign up for updates, and is pretty clear in the provision of the information.  What we don't know, however, is how well the program is doing, what the traffic is to the site, or what the metrics are for measuring success.  

And speaking of measurement, another transparency effort that the agency has undertaken is FDA Track – which Dr. Joshua Sharfstein discussed in an April podcast here on Eye on FDA.  It is an ambitious undertaking to track various metrics on how FDA is progressing in various areas of its vast domain.  At the time of the podcast, a large number of the dashboards available on FDA track were incomplete and were awaiting data.  Unfortunately, they still are.  For example, the dashboard for the Office of New Drugs – information that would be interesting to track – is largely unavailable or incomplete.  The CDER Dashboard seems to have more information, but is only completed through March 2010.  There is a lot of promise to this transparency effort, but there is still a long way to go before it is realized.  

One of the most important areas of transparency efforts relates to the FDA's Advisory Committee structure.  The backgrounds of the individuals who serve as advisors to the agency, along with their ties to industry, is a  cornerstone for credibility to the medical product approval process.  Here, too, the agency has made some progress, but is still incomplete.  In looking at the 16 advisory committees that are responsible for approving drugs, while most members had links to a CV, many did not.  In fact, 10 committees had one or more members with no link to identifying information.  A spot check on other advisory committees also revealed incomplete roster connections. 

It is not easy for an agency the size of the FDA to provide comprehensive transparency.  But the commitment has been made and there has been real effort.  However, to make strides in gaining credibility, the effort still has a way to go.  That is particularly true with the most important of these areas – the advisory committee information – where the task is seemingly not very difficult and the payoff would be great.  

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2 Responses to A Look at FDA’s Transparency

  1. Brian Reid says:

    I’m not so worked up about CVs or FDA Basics. Where the rubber will meet the road is looking at what Task Force recommendations get baked into guidance or rulemaking. You want to really impress me with transparency? Start publishing CRLs (as the Task Force suggests). *That* would change the game …

  2. Joanne says:

    Have you seen the new FDA Basics metrics page?

    http://www.fda.gov/AboutFDA/Transparency/Basics/ucm1176986.htm