With great fanfare, the FDA launched a transparency initiative early this year. The activities included the formation of a Transparency Task Force, the creation of a Transparency Blog, not one but two public meetings held on the subject of transparency, one held in June and one held in November, both of which were Webcast. There is now an entire section of the FDA's Web site that is devoted to Transparency. Presumably all of this effort has incurred some cost of valuable resources, which would lead to the reasonable question – what has the FDA learned from all this effort and what new initiatives have been undertaken?
One measuring stick is the level of transparency among FDA's Advisory Committees. In July after the FDA launched its Transparency Initiative, I wrote a posting called "When Transparency is Easy – Advisory Committee Transparency" that suggested one good place and very easy place to start with transparency was with advisory committee rosters that linked to the CVs of the members of the advisory committees, which had been a prior practice, but which had fallen into disrepair over time. Without the links, the only way to gain access to the bios is to file a Freedom of Information Act request and good luck with that time-consuming and arduous task. In July, a review of the committees in the Center for Drug Evaluation and Research revealed that only about half of the members listed in CDER's advisory committee members were linked to their CVs.
In an update in September, significant progress was found at CDER where the links had been restored among nearly all of the CDER committees. Today I'm including a look at CBER.
A review of CDER's Advisory Committee rosters finds that there are 28 members without hotlinks to their CVs, a 20 percent failure rate. The most absences were on the Pharmaceutical Science and Clinical Pharmacology Advisory Committee, which had a whopping 13 links missing. On the CBER side of things, a review finds that of the 53 advisory committee members, there are 43 links – again a nearly 20 percent failure rate. In CBER's case, these are all on one committee – the Cellular, Tissue and Gene Therapy Advisory Committee. Also included this time around are Food and Devices. Looking at the number of occupied advisory committee slots, one finds that there are still a number of gaps in the provision of links (there are also a huge number of vacancies, especially in device panels).
Moving from an advisory committee transparency rating that was at a 50 percent failure rate to one that is a little over 20% failure rate is real progress and FDA deserves credit for that advance. But for all of the effort to product transparency, is an overall 77 percent success rate transparent enough? Providing these links doesn't seem like a big challenge.
Can't this get to 100 percent? Let's lift the transparency fog.
real helpful transparency beyond these bios would involve webcasting all the committee meetings. What’s so hard about that????
How about getting them to release the marketing advisory informatin redacted from the Bextra approval process? Smmes like it might be the same data rejected by the FDA that was used to market Bextra. At least their are pending cases to make the FDA release the redacted information.
How about getting them to release the marketing advisory informatin redacted from the Bextra approval process? Seems like it might be the same data rejected by the FDA might have been used elswhere according to these pending cases in the public record. At least their are legal pending cases to make the FDA release the redacted information. Instead of wasting the courts time, why not just release the informaton. Opening these old files would certainly make the FDA look more transparent.