Intro: Welcome to the Director's Corner, a new audio podcast series, featuring the Director of FDA's Center for Drug Evaluation and Research.
Anne Rowzee: Hi, I'm Anne Rowzee from the Office of Communications, and I'm sitting down with CDER's Director, Dr. Janet Woodcock, to ask her to reflect on the center's 2014 activities and get a glimpse of her vision for the center in 2015. Hi, Dr. Woodcock.
Dr. Janet Woodcock: Good morning.
Anne Rowzee: Well, let's just jump right in, shall we?
Dr. Janet Woodcock: Sure.
Anne Rowzee: So, what do you consider the center's top three successes of 2014?
Dr. Janet Woodcock: Well, I think as everyone knows in the center, we had a tremendous year. We had so many things going on and we had a very successful year.
What I'd say is one of the top successes is, we reviewed our first biosimilar application and presented that to an advisory committee. Now, what's a biosimilar? That's a copy, kind of like a generic, but not exactly; it's a copy of a biologic drug, and the hope is that there can be these biosimilars that will get onto the market and make the biologic drugs more affordable, because these are very costly often for our patients to receive, but they're very good drugs -- many of them -- and they are very prominent and growing in health care. So, we hope to have a successful biosimilar program, and we did our first review and advisory committee.
Also, in 2014, we made some major changes in how we do things in the Center for Drugs, and these will really impact upon the consumers and the health-care system in the future. And, the first one is we successful launched our new quality office, which we call the Office of Pharmaceutical Quality, and, OPQ. This office will pull together all our different quality functions and has the charge of making sure that all the drugs that people take in the United States are of equally high quality and have been held to the same standards. This is a huge amount of work, of reorganization and so forth, but we're very positive, well, I think we're on a roll with OPQ and we got that launched.
And then the third one, which is also related to reorganization and so forth, is we got our new generics office, super office of generic drugs stood up and functioning, and that's going to oversee all the drug applications for generic drugs. And what are generic drugs? Those are those affordable drugs, that when you go to the drugstore, you don't have to pay very much and your copay is very small. Generic drugs now account for over 85 percent of all dispensed prescriptions in the United States, so these are really important, and it's important that as drugs come off patent innovator drugs, we get those generics out so we can increase affordability for the public, and this office will be in charge of all that. At the same time, CDER launched its new review platform, its IT platform for doing all these reviews, because we get hundreds of generic drug applications each year. We get thousands of modifications to these applications every year, and updates and so forth, and all that work has to be processed through, and our new IT system, which we successfully launched and we're running now, will help us manage all that workload efficiently.
Anne Rowzee: So, lots of changes and lots of efficiency added to the center in 2014. So, were there any unexpected challenges that you experienced in 2014, and how, and how did you handle them?
Dr. Janet Woodcock: Well, we did have some that were quite unexpected, shall we say. First, Congress decided to undertake a drug discovery and development reform effort, and this is called the 21st Century Cures effort, and so we've had a lot of interaction with the Hill. I've been on hearings that have been held, as well as round tables -- Congressional round tables. They've done a huge amount of outreach and asked for suggestions from all sorts of stakeholders, and they have issued a discussion draft publicly that they are now seeking input on a whole bunch of legislative changes, and so that was unexpected, because just 2 years ago we had FDASIA that was, we were implementing, and that had a bunch of user fee acts in it, and many other, many, many other activities that we were charged with doing. So, we are interacting very vigorously in this next round of suggested legislative changes.
And then, we got new legislation on sunscreens. There is something called time and extent applications, which means that sunscreens that have been marketed outside the United States can apply to come into the U.S. monograph process so maybe they could become kind of sunscreens that you buy over on a drugstore counter. There, that would be new ingredients, but here has to be a process to make sure they are safe, they aren't absorbed through the skin. You know? They don't cause any kind of problems, because people are putting sunscreens all over their body, all over their babies' bodies, okay, when they go out in the sun, because that's the prudent thing to do, but we have to make sure that those are safe, and so, legislation gave us a path to rapidly evaluate these external sunscreens and get them into the process that we have, and so we have some short deadlines, and we're trying to adapt to those.
And then we did have some difficulties in implementing our new page on demographics, and I would really love for people to look at that. We've posted that. It's called drug snapshots, and it tells what kind of people were in the clinical trials, how many women, how many men, racial and ethnic minorities, age groups, and so forth, and you can look at all that and say, you know, who was studied in these trials, and we've put that up for when new molecular entity, a new, a very new drug, is approved in the United States, and we're going to keep doing that this year every time, but we're asking for comments. We put a few up last year and asked people to comment on it, and what we discovered is really hard to explain in lay terms all this stuff and make it accessible to people in ways that they can comprehend what we're trying to say. The scientists and the physicians here do all this data and they have all these tables and all this jargon and everything, and, you know, we can't use that with the public. They won't understand what we're saying. So, it was very unexpected that we'd have so much difficulty internally. I should've thought of this, arriving at ways to present this information, it's accessible to the people who are interested in it, which are actually the people who might take that medicine.
Anne Rowzee: Okay, so, looking ahead to 2015, you've recently presented CDER's priorities to the staff and also to folks at the FDA CMS Summit, and so I was wondering if you'd like to share a few of those goals with our audience here.
Dr. Janet Woodcock: Well, sadly, I had pages and pages, slide after slide of various goals, because CDER has so many stakeholders and each one of them has a goal they'd like us to accomplish that's important to them. So, there are major goals, but that doesn't mean all these other things, that we don't have them in mind and we're trying to get them all done. But, I think 2015, first of all, it's the first year for implementation of the GDUFA goals. What is GDUFA? That's another acronym, ok? It's the Generic Drug User Fee Act, and what it did was give FDA more money, industry user fee money, so that we could more efficiently and rapidly review generic drug applications and get them on the market. Because of the success of that industry, we had run up a big backlog, because the number of things they filed to us had increased and increased and increased, and we couldn't keep up with it. So, the industry 2 years old agreed to pay these user fees, but we gave us 2 years to hire all the people and get all the processes organized. So, starting October 1 and through 2015, we're supposed to be on goal for new applications, and we're exceeding that right now. We're very comfortable, but we have to pay a lot of attention to that, and that has to be a No. 1 goal is to make sure we meet those deadlines. Second, we've launched the Office of Pharmaceutical Quality. That I've already talked about, but we really need to have a strong start for that. We need to get that ship sailing and robust and stay afloat and everything. I'm the Acting Director of the Office Pharmaceutical Quality right now, because I'm an experienced manager of change and organizational transformation, and that's really what OPQ is all about. So, I'm helping that organization in the implementation team there make those changes.
We need to maintain also, though, attention on the 21st Century Cures effort. So, that'll be a priority for us. Because if drug regulation is to be changed and there's to be legislation that changes the way we do things, we think we can have a lot of input into that, because we know often how the, what the implications of those changes. Sometimes things sound like really good ideas, but actually when you see what they actually would do, they could be not what you intended and have a lot of unintended consequences. So, we are keeping our eye on that.
Another thing that's going to happen in 2015, hopefully, will be we'll launch our new compounding program. If people remember, a number of years ago, we had a terrible incident where many people were harmed, and many -- some people died -- because they received a contaminated spinal injection of steroids, and this brought attention to pharmacy compounding and how it was kind of not the traditional compounding that used to go on and posed a lot of risks, and we had a big legislative process. After that legislation was put into place and a huge amount of work has occurred at FDA. We've done a large number of inspections of pharmacies. We've worked with the states and we're working on putting out a whole framework around this. We hope to see a new industry grow up, called outsourcers, of people who actually make sterile products for hospitals and clinics who actually just take larger forms that are made, that are regular drugs, and break them down into the kind of form that a hospital or a clinic might use, like a syringe, a pre-filled syringe or smaller doses or whatever. So, that's compounding. We hope to come out with a lot of guidance and instruction for industry this year and keep that program moving forward.
And, finally, we need to continue to implement and broaden our IT platform. That sounds like a very wonky type of thing but for a business as ours, our business has tens of thousands of decisions that we make, probably thousands of decisions every week that must be made. Most of them have deadlines. They're important. They impact people's lives. They impact safety, so we have to be right, and we have to be on time, and we have to be able to reconstruct our decisions and have a record and documentation, and so the new IT platform will do, will make the decisions, right? But, it will make the timing, the timelines, the documentation, the workflow and so forth much easier than what we have now, but, as everyone knows, putting in place a broad new IT system and replacing all kind of old databases and so forth is fraught with real pain, suffering, and, and a lot of energy has to be put into it. So, we're gonna press on this year, and I hope by the end of 2015 that we will have a platform that we're all using that people are semi-comfortable with. There are still gonna be glitches, but we would've gotten through much of the pain of this transformation.
Anne Rowzee: All right. Well, so to put you on the spot a little bit, if we could make one of those goals happen right now, which one would it be?
Dr. Janet Woodcock: We? No. If we had our IT platform in place 10 years ago, that would've been my goal. Ever since I, I came to the center, I've been trying to build and get better IT, and I've never had the proper human or financial resources to get this done. We're getting it done now. We're doing it right, but if it had been done 10 years ago, we'd be in so much better a place now.
Anne Rowzee: So, expanding on that, and thinking a little bit more broadly, so where in the realm of drug discovery, research, and development would you most like to see advances? So, kind of outside of CDER a little bit?
Dr. Janet Woodcock: Well, we've been working in the past many years on trying to reform the clinical trial system in both the United States and worldwide because clinical trials are very resource wasteful in a sense. They, for drug development, they set up a trial all around maybe the world, and with different investigators they run the trial, and then when the trial's done, they shut all that infrastructure down, and if you need another trial, it all starts up again, and so that wastes a lot of time, a lot of resources. We have tried and are working on several master protocols that continuously run and can evaluate numerous investigational products at once, and many over time, because the trial doesn't shut down. I would certainly hope that that type transformation could continue. We're also working with the CTTI Group, which we're a cofounder of the Clinical Trials Transformation Initiative, to bite off different pieces of the current trial conduct and design and re-design those, and I think we've made significant progress there, but I think for drug development, amongst tractable problems, okay, this is a problem that could be fixed. Okay? With vision and with persistence, we could develop a better trial system that could effectively and quickly evaluate therapies and really evaluate them dispassionately.
One of the other problems with trials, at least in many people's mind, is that they are funded by the sponsor and conducted by people the sponsor pays. In these master protocol-type designs, you have a trialist group, and they take money from many sponsors to evaluate their product, but they're more or less independent, because they're evaluating many different products, and this, to me, gives one degree of separation that would give a lot of people comfort about how these, how the data was generated and could be interpreted and relied upon. So, that's one, big change that I think would really be helpful.
Anne Rowzee: Well, thank you so much for sitting down and talking with us today.
Dr. Janet Woodcock: Most welcome.
Exit: Thanks for listening. For more information about what you heard today, please visit our web site at www.fda.gov/drugs.