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 for the Director’s Corner podcast. Today, Dr. Janet Woodcock reflects on CDER’s accomplishments for 2016.

Dr. Janet Woodcock, CDER was extremely productive last year. Can you tell us what you think were our most significant achievements?

Janet Woodcock: So, to start with some of the accomplishments of last year’s busy activities, first of all, our Generic Drug User Fee program has really been performing spectacularly. And we actually exceeded some of our goals by one year of what was expected of us in the program. We still have a massive numbers of filings to deal with, but we have met all of the GDUFA goals we agreed upon and we have successfully negotiated with industry on a proposal for GDUFA 2. So this is a tremendous accomplishment and I really recognize the people who just worked their hearts out in the Office of Generic Drugs and OPQ and the other programs that contributed to this. It has been a massive undertaking and a really significant achievement.  And on the New Drug review side, our new Drug Review program,  that continues to be a success story. We’re meeting our PDUFA goals. We’re also seeing a lot of breakthrough therapies, we designate a lot, and we’ve actually been approving a fair number of breakthrough therapies as well as drugs that have other expedited programs associated with them, and a significant amount of orphan designated drugs for conditions that really don’t have much medical treatment right now. And, that’s good news for the patients. So last year we had somewhat fewer NME than the year before, but this is a small number and it goes up and down over time, and really dictated to great degree by what industry sends us in that year. So, this year, I am currently the acting director of the Office of New Drugs and look forward to overseeing that program. And then finally, I wanted to talk about drug quality regulation. OPQ has had a year of standup. It was a massive reorganization between the Office of Pharmaceutical Quality and the Office of Compliance. That has been completed. The program is humming along. We’re still struggling in the backlog in the generic world, but we’re dealing with it. And, from all accounts, both internally and what I hear from external stakeholders, the quality, the clarity of the communications from OPQ have been outstanding, but I salute the folks in OPQ. Director Mike Kopcha, Deputy Lawrence Yu and all the other folks who are working very hard. You contributions have made a huge difference and I think we’re on a good path toward better regulation of pharmaceutical quality. Our outstanding achievement this year has really been getting our hand around the inventory of facilities that manufacture drugs around the world and really being able to get that into a database and understand what these various facilities are making, where they’re located, and so forth. Hopefully, that will only get better over time. Now on another note, our regulation of pharmacy compounding proceeds apace. We had a very big year this year with inspection of over 400 facilities that make compounded drugs. And of course, we’re continuing to find a high rate of lack of adherence to good practices for making these compounded products. And, many of our inspections have to be followed up with various enforcement actions, recalls, and so forth. But we are making progress in this area, we’re attempting to establish a new kind of industry, the outsourcing industry that was created under the statute. And this year, we’ll continue to take steps. We’re also implementing the statute around compounding and we’re doing things like having advisory committee meetings of the Compounding Advisory Committee, and so forth. So, 2016 was a very busy year for our regulation of pharmacy compounding.

Likewise, our activity in review of biosimilars is picking up. We’ve long had products in the program, in other words undergoing development, comparative assessment, and so forth with the innovator product. But now, as of the beginning of 2017, we have approved four biosimilar drugs that can come on to the U.S. market. And so, this is becoming real. The subspecialty groups that use these innovator products are taking notice and there is beginning to be uptake of biosimilars in the United States. We expect slow, incremental gains over the years in the number of biosimilars. We also finally managed to release guidance on naming and interchangeability—these had long been difficult to get out. And so, we have a real package, I think, of how we’re going to regulate biosimilars out there for the world to look at and to comment on in some cases. So, we have made, in 2016, we have made substantive steps in biosimilar regulation.

Now I mentioned some of our User Fee negotiations earlier, but actually we’ve had multiple negotiations of not only GDUFA but we successfully renegotiated a proposal for PDUFA with industry, as well as for the biosimilars. Also, we’ve been talking to the self-care industry about the over- the-counter monograph system and reform of that system. And intense negotiations went on in 2016 that culminated with some proposals and some semi-alignment, I would say, with both changes to how we do the OTC monograph system as well as User Fee program to support it.

Another activity we’ve been working on is integrating our sentinel system which has now grown-up, and is a real system, into the everyday activities of OSE and Safety Surveillance. And that has been going on over this year and continues to build and grow. And I would say that is successful, we expect to have a Sentinel public meeting soon where we go over all of the ways we’re using Sentinel as part of our ordinary safety surveillance activities, not just as an experimental system off to the side. So that’s a very good landmark to celebrate that we achieved in 2016.

Of course in 2016 we were also working on implementing provisions of various statutes that had been passed. One of these was the Sunscreen Innovation Act that had a lot of directives for us to evaluate rapidly new sunscreen ingredients and so forth and put out the standards. We have done that. We have issued four guidances and one final rule in this space. We have met the provisions that were in the Sunscreen Innovation Act and we can expect to keep working on that in the future. We also, on the drug development side, have been implementing the agreements in the user fee program on patient-focused drug development. And, we’ve had 20 meetings so far, patient-focused meetings, where we get the voice of the patient, the input of the patient. And, we have published results on that. So we had quite a few this year. They’re very popular. And this year also marked the beginning of patient groups holding their own patient-focused drug development meeting to which they invite us and manufacturers and others. And then they would give us a report of the voice of the patient. So this hopefully will leverage us in the future in our efforts. I have, since that time, very recently, gotten two recent invitations to externally-led, patient-focused drug development meetings in various rare disorders where the patients are really interested in organizing efforts to make sure their concerns are met in drug development.

Colleen Labbe: Dr. Woodcock, thank you for providing your insights 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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