Introduction: Welcome to the Director's Corner, an audio podcast series featuring the director of FDA’s Center for Drug Evaluation and Research.

Colleen Labbe: Hello! I’m Colleen Labbe from the CDER Office of Communications. Thanks for joining us. In the previous podcast, Dr. Woodcock reflected on CDER’s accomplishments for 2016. Now she will give us her perspective on the goals we have for this year.

Dr. Woodcock, what do you expect will be our main priorities in 2017?

Janet Woodcock: In the summer, the executive committee of the FDA had a retreat, a strategic retreat, where we talked about what we really needed to focus on to move all the programs forward. And, the number one item there was improving and really implementing Informatics Process Management and so forth across the whole Center. And so that is our highest, number one priority and we’re putting a tremendous amount of effort into that. To that end, we have set up a governance board we call the BIG, Bio Informatics Governance, and under that we will have the data standards effort, the standards boards, the change control boards, as well as process control boards and process governance as well as the IT that works into that. Now we’ve already implemented the platform in the Generic Drug Review process and in other small processes around the Center. We hope in October to be implementing the platform in some parts of the new drug review process and we hope to keep building on that. But, this requires discipline, it requires that we do have change control boards and governance boards over data, over process standards and that we standardize our processes so they can be automated. The payoffs from this are just tremendous. But it’s expensive and it’s time consuming and every time you have to adopt a new IT system there are issues and it disrupts the workflow for a while. So I hope people will bear with us as we do this. Hopefully it will get better as we do it repetitively over time. We hope to have a five-year plan that we put forth that everybody can see that shows which processes are going to be worked on and standardized and then which ones could be put into the platform and automated so that eventually this will all come together into a coherent system that will provide much more information and knowledge management for everyone in the Center.

Our second priority is implementing the recent provisions of the [21st Century] Cures Act. We are still analyzing the Cures Act to see when we have to implement some of these things. Some of the provisions don’t have timelines, but in fact, the sooner the better for some of them because we might as well working under statutory framework that’s been enacted and not stay in whatever old process we were doing. So, we performed an analysis of the Cures provisions, which ones CDER will have to do, because of course there are many different  things in the for NIH and CMS and so forth as well as for other programs like the Device program. But what is CDER’s responsibility under the Cures Act and then what are the timeframes and deliverables for each one of these responsibilities. And we’re not finished with that, but as soon as we get close we’re going to have to put together working groups and really start making this happen.

Another critical priority, which we’ve done much of the work on, we think, up till now, is going to be shepherding and providing technical assistance to the reauthorization of these various User Fee bills as they move through Congress. Another priority for me personally, is the work I plan to do with the new drug review program in the coming year. We’re undergoing a process to more or less re-invent, reimagine, refresh, or reinvigorate the new drug review process. I’ve held listening sessions for the past four months now with the staff in OND and I’m going to have listening sessions now with OTS staff and hear what’s working about the program, what’s good, what are best practices, what are pain points, what could be changed, what are the suggestions, and so forth. We’ll also be having a contract to more widely gather information of that sort that hopefully will be implemented soon and then we’ll have multiple work streams for change.

We have to continue to press onward on our work on the opioid epidemic and tick off parts of the action plan that we committed to. We are continuing to approve new abuse deterrent formulations. We really need to work on encouraging new non-addictive pain treatments whenever we can, because that is one of the major sources of both the opioids that are awash in the system out there, as well as people who inadvertently  become habituated to the drugs—it’s just the massive amount of exposure.

We also need to continue to modernize the assessment of manufacturing facilities. This is a really important activity that we’re just starting on. It wasn’t completely baked in to OPQ. It is a shared activity between our Office of Compliance, OPQ, and ORA. And ORA is undergoing a massive reorganization as part of the “PAG” activity. Once that is done we’ll have a new way of interacting with ORA and we’ve already worked out a concept of operations of how that’s going to work. But we’re going to need processes and procedures under that. This is very important to the industry that we have a very transparent process with timelines and so forth for when we find problems with a facility. So that’s something I’ll be keeping my eye on over the next year to make sure that we move along.

In addition of course, we managed to negotiate very recently a mutual reliance initiative—an agreement with Europe. And so, that will allow as it’s implemented, sort of country by country, will allow us to rely on those inspectors in that country to inspect facilities in their country and we will not have to inspect those facilities.

Other activities that will be important, and there are many so I can’t even mention them all, but we recently formed the Oncology Center of Excellence in OMPT. And Rick Pazdur is the head of the Oncology Center of Excellence, and we will be working out how we work with the Oncology Center of Excellence in review and they’re going to have research activities and outreach activities and we’ll be working on how we work together with them. I expect them to be an engine of innovation and change in how we do many activities that we do within new drug review.

And then finally, compounding—we can’t let up on that. We continue to have deaths and harm from compounding. We did in 2016, and we will probably continue to have that. But we have to work out a way that will not totally strain our resources and the field’s resources so we can conduct our other obligations, but at the same time manage to control any harm that would be coming from pharmacy compounding.

So, we look forward to another busy and productive year in which we continue to assure that Americans have access to safe, effective and affordable drugs.

Colleen Labbe: Dr. Woodcock, thanks so much for your insights. I appreciate you joining me today

Exit: Thanks for listening. For more information about what you heard today, please visit our web site at www.fda.gov/drugs

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