[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 with the CDER Office of Communications. Today, I'm talking with Dr. Janet Woodcock about the state of the center as we look back on the accomplishments and highlights of 2017, and look ahead to what is planned for 2018. Dr. Woodcock, thanks for joining me again today.

In 2017, our user fee programs were reauthorized. Can you tell us more about that?

Dr. Woodcock: Sure. I think this was a great milestone for the center. Three of our user fee programs were reauthorized—prescription drug user fee program for the sixth time, biosimilars user fee program, and our generic drug user fee program, which had gone through a lot of effort and a lot of changes over the last five years. So, this was terrific for the center because we do have the resources now to keep these programs going. For the generics and for biosimilars, this provides more access for consumers, hopefully more competition and more affordable drugs. And on the new drug side, of course it's the innovation, treating untreatable conditions and so forth that really makes that program so important.

Colleen Labbe: Can you describe how we are working to modernize the new drug review process?

Dr. Woodcock: For some time, we've been working on modernization of the new drug review program. The new drug review program goes beyond the Office of New Drugs and includes Office of Translational Science, Office of Surveillance and Epidemiology, and of course our quality program, and we're really now deeply into that, and I think that'll be a central theme for this year. We're looking to react and be able to manage the new science that's coming forward, all the rapid changes, the great interest of patients and patient-focused drug development, the requirements of 21st Century Cures that we develop, help develop, drug development tools and qualify them and many other changes that are coming. And so, we are going to really modernize the whole program in order to meet these new challenges.

Colleen Labbe: So, speaking of 21st Century Cures, can you describe more of our efforts to implement the 21st Century Cures Act?

Dr. Woodcock: Sure. We have an entire program dedicated to all the different provisions of 21st Century Cures. For example, Theresa Mullin is in charge of the patient-focused drug development that's very, very important to patients and patient groups, and there are a lot of different aspects to that. We just had a public meeting. It was very successful, and we'll be doing more and, issuing guidance and so forth in the coming year. We also are working on the drug development tools as I said, and qualifying those and putting in place the new requirements of 21st Century Cures. And then we're putting in place many of the other programs that were stipulated in that legislation. So, another part of 21st Century Cures was giving FDA new hiring authorities of several kinds, and the agency as a whole has been working on that. Our Melanie Keller, who is the head of our Office of Management in CDER, has been spearheading the efforts to put this new program into place. We look for that to happen this year.

Colleen Labbe: So how are we continuing to address compounding issues?

Dr. Woodcock: Compounding remains a very prominent topic for the center. On one hand, we're having to do a lot of enforcement, inspections and so forth, making sure that the compounded drug supply is safe. On the other hand, we're standing up a new program, a whole new industry, the 503(B) outsourcing industry, and trying to get that up to speed. Then we're having to do a lot of efforts on rules, regulations, guidances, about all sorts of things, and we've been having multiple advisory committee meetings about what kind of drugs can be compounded from bulk drugs. So, there's a tremendous amount of activity going on in the compounding space, and that will continue this year.

Colleen Labbe: How are we addressing our need to integrate improved technology into the regulatory process?

Dr. Woodcock: Well, when you talk about new technology, you're talking about everything from new ways of doing drug development all the way to, can we get our IT platform up to a very useful stage. So, sometime this year we hope to instantiate the, what we call the platform, which is our workflow management system that is fully operational for the generic drugs review program, into the new drug program and get that started. We’re also using that platform in many other areas of drug regulation right now. But we also have major needs in informatics, in post- marketing safety, surveillance and so forth. So, I think we can, one of the activities you can look for us to do this year is to try to get an integrated plan together for how we're going to bring all this informatics activity together.

Colleen Labbe: Great. So we continue to address the opioid crisis. Can you tell us a little bit how?

Dr. Woodcock: Well, as most people know, deaths from opioid overdoses continue to go up in the United States. And so, of course FDA has a part to play in this, although we're not by any means the only player. So we're trying to look at ways with the opioid task force that Dr. Gottlieb has established, to try and figure out how we can reduce the number of people who become dependent on opioids or develop opioid use disorder, and that might be, we're exploring ways that we might reduce the exposure to opioids in the patient population, perhaps by prescribing fewer tablets or by using other pain modalities. Another thing we're working on is to try and help better treat people who actually have opioid use disorder, and that includes medication assisted therapy. We recently approved a new form of buprenorphine, which is a depo form that can be used monthly to treat this disorder. And then we have a number of safe and effective products on the market, and we're also exploring many other things. We are changing our REMS and will be implementing that during this year. And we're looking at the benefit risk calculus for opioids very closely and we will be continuing that activity and many other activities on opioids in the coming year.

Colleen Labbe: Okay. Dr. Woodcock, thank you for sharing your thoughts today. We look forward to 2018.

Dr. Woodcock: Thank you very much. I look forward to it as well. I think it's going to be an active year for us. We still, although we had the user fee programs reauthorized, we didn't get the OTC program that we were very interested in, both the policy reforms and the user fee program, you know, was not passed by Congress. We're very interested in seeing what Congress will do this year and we have a full plate of things we have to do, both implementing new legislation and our ordinary work. So I'd like to thank everyone in CDER for really puttin' their shoulder behind the wheel last year. We had a banner year in almost every part of our program. It was really outstanding, and hopefully we'll see the same level of performance this year. So thank you all.

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