Transparency and FDA Advisory Committees

J0407327The agency is not doing everything that it should in order to support transparency in the advisory committee process, and it needs to do more.

The relationship between members of FDA Advisory Committees and the industry that produces the products they consider for approval has been a subject of growing concern.  After the election cycle is over, no doubt questions will continue and even intensify.  It is therefore important that the agency do all in its power to ensure that the transparency that is in place be executed to the greatest degree possible. 

On the FDA Web site, there is a list of each advisory committee and each member of each advisory committee usually has a link that takes you to their CV.  That is a very good mechanism for both consumer protection groups as well as industry who want to analyze the makeup of a committee.  It used to be that you could only obtain these CVs by filing a Freedom of Information Act (FOIA) request. 

However, if you look at just the CBER an CDER committees, there are several exceptions.  Many of these members do not have a link to their CVs.  Why?  They must all have CVs.  Why do some have links while others do not? 

An examination of 21 committees finds that of there are a number of deficiencies.  Of the 16 CDER committees I examined, only 1 roster was complete with links to all of the member resumes (Anti-Infective Drugs Advisory Committee).   CBER did somewhat better – of the 5 committees in CBER, 2 had complete links (Blood Products Advisory Committee and the Vaccines and Related Biologics Advisory Committee). 

For CDER, there were 168 linked members, with 46 unlinked, a failure rate of over 20%.  Within CDER there was one committee where 7 of 12 members were not linked to resumes and a total of 4 committees (or 25% of the CDER total) had over half of the members unlinked.

Within CBER, there are a total of 65 members, 18 of which were unlinked to CVs, or over 30% failure. 

Overall, between CBER and CDER there are 279 advisory committee members, 64 of whom are not linked to any information – a failure rate of about 25%.  Sometimes a telephone call to an Executive Secretary is helpful, sometimes you are rudely told you have to file a FOIA. 

In a time of increased demands and potential reforms, keeping this mechanism up to date is an important measure for the agency to demonstrate that transparency is not an ideal, it is a fact when it comes to agency policy.  Transparency, in order to be genuine, has to be consistent.

In addition, before each advisory committee meeting, it is announced that the conflict of interest forms can be obtained by filing a FOIA.  Why not post these with the documentation of each advisory committee meeting rather than demand a FOIA.  If the information is freely available, why does the agency make observers and agency analysts jump through this hoop. 

These days, even the appearance that the agency is not acting in a transparent is a risk that it cannot afford. 

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