The drug approval process has long relied on advisory committees to provide input to the FDA regarding a candidate drug. For a long time, this process was somewhat mysterious. Over time, it has evolved to a highly transparent level. Meetings are open, advisory committee members CVs are posted on the FDA Web site, votes are in the open, discussion is in the open and backgrounds of committee members are scrutinized. Transcripts of meetings are posted, FDA slides are posted – the system is pretty transparent and, I believe, fairly strong. For example, in Europe, the EMEA is not nearly as transparent as the FDA.
The extent to which this is true does not appear to be appreciated by National Research Center for Women & Families, who sponsored a report implying advisory committees are biased in favor of drug approvals, according to a story on FDA Advisory Committees in the Washington Post this morning.
Randall Lutter, associate commissioner for policy and planning at the FDA made two points in the article. "First and foremost, it is an advisory committee process, and in that sense panels do not make decisions, they offer advice." That is a major point and it seemed somewhat clear to me, as someone who has attended scores of these meetings, that the group making this point did not seem clear on the context for these advisory committees. It might benefit the FDA to create a playbook around the issue of advisory meetings as this is a subject that is not going to go away.
I, for one, have attended scores of FDA Advisory Committee meetings over the past 10 years and worked with a large number of clients preparing their presentations before these committees. In that time, I have seen a large number of drugs voted down. A lot get passed, but it is important to note that these drugs are being considered for approval because they have gotten through pre-clinical and three phases of clinical trials, the results of which encouraged continued and substantial investment by companies. By the time these drugs get to committee consideration, they have been heavily scrutinized and cleared a number of hurdles. It is not as if they are all starting from scratch by time they get their, the candidate drugs themselves, by virtue of the clinical trial process, are predisposed to passage.
It might seem that the more transparency there is in the process, the greater the foothold for critics of the process, the agency and the industry. That would be a cynical point of view, I suppose, but nevertheless true. Still, that should not discourage less transparency, but should encourage top notch issues management planning on the part of the FDA and the industry around this and many other topics of potential controversy. Because one thing is for certain, controversy is going to continue, particularly in the election cycle, and the agency would do well to have a playbook that helps them make the best arguments possible, rather than respond on a case by case basis.
Mark, being on the manufacturing and development side for many years now and knowing the numbers gmae the pharma companies play, it only makes sense that the majority of products making at all the way to an external advisory panel would get a positive nod. By this point in the process all of the true losers shouls have been eliminated. I have a blog posting about this that will come out tomorrow on the QDIS blog.