FDA’s CMO Dr. Janet Woodcock: Success Stories Will Be the Best Publicity for Critical Path

Next month's issue of Pharmaceutical Manufacturing will feature a brief cover story on FDA, focusing on some of the things that the Agency is doing to change its internal culture and strengthen its image. Below is a transcript of the interview that we (Pharmaceutical Manufacturing, or PM) did with FDA's Chief Medical Officer,  Dr. Janet Woodcock, who is now charged with raising the level of scientific thinking and inquiry, and bringing more transparency and internal debate to the Agency.

 PM “ Congratulations on your new position. What are your top goals as CMO, both in the short and the long term?  After your years at CDER, where your team did a lot of work that applied engineering science and statistical process control to drug manufacturing, do you feel that you're returning to your roots as an M.D.?  


JW “ Ill be working in the area where medicine comes together with these other concepts quite a bit, and I really look forward to that.  Now is the time where medicine can become more of a science and less of an art.  Were at the forefront of advancing that at FDA.

Short term, well have a research review and science review in the Agency, to see whether were organizing and utilizing scientific information in the best way possible. 


Another focus will be our bioinformatics process that weve set up that I chair.  I also want to develop an enterprise-wide planning process for IT use at the agency. 

These are "modest goals," but Im working on them.  We've had the bioinformatics initiative in place for  going on for a year, and wed like to see some very substantive accomplishments come out of that initiative over the next year.

In the long term, we want to utilize the emerging science in the most effective way to modernize FDA regulation across all regulatory areas.

PM “ It's difficult enough to apply modern quality concepts to drug manufacturing, but applying them to clinical work and R&D seems even more challenging. What do you see as the top potential obstacle to realizing your vision?


JW - As usual when you bring about change, the hardest part is getting people to embrace that change and to put in the effort needed to implement the changes. It takes a lot of work on everyones part but [the reasons for the change are] so compelling.  For example, in the clinical world, we wont just improve regulation, but we can improve how medicine is used, we can improve the safety of medicine and its utility for the population. The opportunities are tremendous and worth the effort.

PM “ What do you see, overall,  as the Agency's top goals this year?


JW “ The Commissioner has already articulated that his number one priority will be readying the Agency for the new science thats coming, so that we can be a bridge to better health for Americans.  I will be working on that.


Second is strengthening the FDAs management and organization so that scientists can be supported and well be stronger organization. We want to establish a  good scientific culture of openness, transparency and the discussion of science at the Agency.

PM “ We sometimes hear, anecdotally, of a "disconnect" between the Agency's professed goals and daily reality.  For instance, some of FDA's inspectors and others may not really be on board with some of the new programs.  Is it possible that the Agency might implement a performance review that's more like the one used in industry, where people could be dismissed if they couldn't adapt to change?


JW - Its [not a question of dismissing anyone] but more that we need to have vigorous internal debate and decide on a direction, in concordance with our leader.  Those who really cant get on board with that will have many options available to them after weve had complete opportunity for discussion internally and debate about the direction in which were moving.

In the product quality initiative, for instance, there may be some folks who do not agree or cannot put in the effort required to change to a new way of doing business.  Thats OK, but perhaps it will just be time for them to contribute [to the Agency] in some other way.

PM “ What concrete changes have you seen within the industry since 21st Century GMPs and Quality Documents were published?


JW “ We expected that changes on the shop floor would be slow. Theres a lot of capital sunk into existing systems and approaches, and equipment and everything. Change is going to take a while [on that front].

But what were doing is trying to invite and enable that change, without forcing it. Right now we are changing the way that we do reviews, because we know that will drive change on the outside. We're going to institutionalize QbD in the way that we review and regulate in the CMC area.  That is not a trivial task but were well along the way in doing that. Thats very important. The field and the office of compliance are all on board with this and were moving along.


In short, we have a three-pronged strategy. Were trying to advance the science in different ways with academia, with with consortia that have been formed.  Were changing the way we regulate and then were harmonizing internationally and Im surprised by how much progress weve made in ICH in the quality area. 

Industry has been perfectly clear that [we need to harmonize regulations internationally] Right now, the same production line is regulated by many regulators, and [there's] a situation where people are coming in and [each of them may] have his own interpretation.  That [type of system] sets up [the potential for] errors and problems.

PM  But isn't ICH giving the 60,000-foot view? How about closer to the ground? Which standard setting groups will be most important to ensuring that ICH principles are implemented in day to day operations?

 JW -   Were working with all the key standard setting organizations: USP, ASTM, and weve also applied to join PICS.  Were also working with professional organizations such as ISPE.  We need to do this because were attempting a whole culture change.  Weve been doing things virtually the same way for over 30 years.

We know that its going to take a while Im actually surprised by the vigor with which people have introduced and adopted ICH, even within the industry.  Not so much on the shop floor, perhaps, where people have invested so much [in existing systems], but in new drug development.  Thats where I think well see a lot of the transition happen because they havent sunk costs into that yet. 


PM “ Will there be any efforts made to engage "the man in the street" as far as Critical Path is concerned? Are any public relations outreach programs planned?

JW -  We have to devote our resources to accomplishing the very important tasks [outlined in Critical Path}. Thats our first priority, but we hope that people learn about advances.   

The public doesnt always understand conceptual ideas all that well and it can be difficult to relate those ideas. Its much better to have a result and then say Look what weve done here.


One of the efforts that are furthest along is what Critical Path is doing with predictive safety markers, as part of the predictive safety consortium. Some of these markers are looking really good. If we can get some new predictive safety markers, that will be teriffic [in communicating the importance of the Critical Path to the public] because anyone can understand it. It is a fantastic initiative.