The Uninvited (part 2): FDA offers more detailed explanation for Kaul’s absence on prasugrel committee

In response to queries from CardioBrief, an FDA spokesperson, Sandy Walsh, has provided the most detailed explanation yet of the sequence of events leading to the withdrawal of Sanjay Kaul from the Cardiorenal advisory committee meeting for prasugrel.

Previously the FDA told CardioBrief that “the FDA did not receive sufficient information until much later than we would prefer…” In response, we observed that according to our understanding FDA committee members undergo a very detailed and rigorous review process over a period of several months.

The FDA has now modified its earlier position about this. Here is the spokesperson’s response:

I personally had a misunderstanding of the sequence of events. The FDA did indeed get the information that we asked for from Dr. Kaul during the screening process. Dr. Kaul did everything he was supposed to do. He submitted all the paperwork that was required to be on the committee and to be screened for the committee. When questions were raised about his abstracts, he responded promptly.

The conflict-of-interest screeners were satisfied that there wasn’t a financial conflict with Dr. Kaul’s abstracts. However, they did not question whether these studies might represent an intellectual bias, so they didn’t relay the information about that to the CDER Division of Cardiovascular and Renal Drugs. The Friday before the meeting, the drug review division became aware of the five abstracts and that is when the questions were raised about whether they constituted an intellectual bias. Discussions were held over the weekend among FDA staff and in the end it was decided that there wasn’t time to fully vet the question.

The FDA wants to make it very clear that no determination was ever made that Dr. Kaul had any conflict of interest, there simply was not time to discuss the questions before he had to travel for the meeting.

Fair enough, but there is still one large question remaining here. How did the drug review division become aware of the five abstracts? Specifically, many observers have wondered what role the sponsor (Lilly) may have played here. I have asked the FDA to provide further clarification about this.

CardioBrief also asked the FDA to clarify its previous remarks that Kaul was removed “in order to enhance the credibility and transparency of the advisory committee proceeding and in an abundance of caution…” An equally credible argument could be made that the credibility and transparency of the meeting was harmed by his absence. Here is the FDA response:

The FDA wants advisers to critically analyze data and we want our advisers to come to the table with an open mind to look at the data, hear the presentations, hear the discussion, and then give the agency their perspective based on all of that information.

In the case of Dr. Kaul’s traveling to the meeting, a judgment call had to be made by the agency at the last minute. There simply was not time to complete the vetting before he had to travel for the meeting.

The FDA would like to emphasize that Dr. Kaul did everything he was supposed to do. There was no official determination that he had an intellectual bias that would preclude him from serving. The FDA plans to improve our internal procedures to avoid these last minute issues whenever possible and to involve senior management in any decisions relating to participation.

We hope that Dr. Kaul will continue to serve the committee going forward.

Click here to read our previous post about the FDA’s explanation.

In the right hand column of this blog you can find a complete list of our prasugrel coverage.