Advisory Committee Transparency Update – FDA and EMEA

In the United States, new medicines are considered for approval by various consultant committees that the FDA  uses to help assess an application for approval.  In the European Union, human medicines are considered for approval by the European Medicines Agency (EMEA) with the support of the Committee for Medicinal Products for Human Use (CMPH).

It used to be the circumstance that if you wanted information about the makeup of the committees, you had to file a Freedom of Information Act (FOIA) request with the FDA to obtain the CVs of the members of a particular committee and if you wanted to know more about the members of the CMPH, you were bound to remain curious.

Today, both agencies provide much more transparency and both the EMEA and the FDA have embarked on pathways to ensure greater transparency of its proceedings.

Now the EMEA actually lists not only the membership of the CMPH, but also includes links from the roster to each CV of each member as well as to their disclosure statements.

The FDA in the past, has had some links to CV information, but not all, as noted here.  In updates, it has been noted that there has been progress, but still not complete transparency involving the linkage of members to their CVs.  Unfortunately, there are still committees that do not have links to CVs, such as the Cellular, Tissues and Gene Therapies Advisory Committee, which has only one member linked to a CV.  Disclosure statements are not present.   Almost there!  But not quite.   

Today, the FDA has announced the publication of a "Draft Revised Guidance on Transparency and Advisory Committees" that would "expand transparency and disclosure when the agency grants a conflict of interest waiver" to an advisory committee member to participate in a meeting.  

The work on transparency is indeed important and the steps outlined in the remarks from the Commissioner and the draft guidance itself are great strides.  But, the CV issue is still outstanding and the FDA would do well to close the gap as a means of reassurance that future goals will be obtained.  

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