05-09-17 FDA Opioid Workshop - Final (Transcript with index)

426 Pages·2017·0.81 MB·English

FDA - Training Health Care Providers on Pain
Management and Safe Use of Opioid Analgesics
May 9, 2017
A Matter of Record
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Min-U-Script® with Word Index
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1 FOOD AND DRUG ADMINISTRATION

2

3

4 Training Health Care Providers on

5 Pain Management and Safe Use of Opioid Analgesics

6

7 Exploring the Path Forward – An FDA Workshop

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9

10 Tuesday, May 9, 2017

11 8:37 a.m. to 5:03 p.m.

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13

14

15

16 Sheraton Silver Spring

17 8777 Georgia Avenue

18 Silver Spring, Maryland

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1 C O N T E N T S

2 AGENDA ITEM PAGE

3 Opening Remarks

4 Janet Woodcock, MD 8

5 Ongoing Efforts to Address the Opioid

6 Epidemic

7 Douglas Throckmorton, MD 21

8 FDA ER/LA Opioid Analgesic REMS

9 Claudia Manzo, PharmD 31

10 Opioid Prescribing Education and Prescription

11 Drug Monitoring: A State by State Overview

12 Lisa Robin 44

13 Overview of State Efforts to Promote

14 Prevention and Education: National Governors

15 Association (NGA) Experience

16 Melissa Becker 53

17 New Mexico – A State Experience:

18 Implementation, Maintenance, and Evaluation

19 Joanna Katzman, MD, MSPH 63

20 Questions and Answers 76

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1 C O N T E N T S (continued)

2 AGENDA ITEM PAGE

3 Provider Education and Outcomes

4 Fred Brason 94

5 Federal Healthcare System Experience: VA

6 Implementation, Maintenance, and Evaluation

7 Chester "Bernie" Good, MD 110

8 Private Healthcare System: Kaiser Permanente

9 Carol Havens, MD 121

10 Questions and Answers 137

11 Federal Mechanisms for Required Training

12 Prescriber Education: FDA REMS Options and

13 Considerations

14 Doris Auth, PharmD 149

15 DEA Perspective

16 James Arnold 168

17 Open Public Hearing

18 Norman Kahn, MD 180

19 Thomas Sullivan 183

20 Cynthia Kear 189

21 Eunan Maguire 192

22 Katherine Cates-Wessel 195
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1 C O N T E N T S (continued)

2 AGENDA ITEM PAGE

3 Open Public Hearing (continued)

4 Richard Lawhern 200

5 Laura Wooster 204

6 Clif Knight, MD 206

7 Ilana Hardesty 210

8 Steven Passik, PhD 213

9 Ashley Walton 217

10 Linda Cheek 220

11 Kara Gainer 223

12 Panel Discussion – Professional Associations

13 Terry Toigo, MBA, RPh 226

14 Questions and Answers

15 State Panel Discussion

16 Peter Lurie, MD, MPH 299

17 David Brown 300

18 Questions and Answers 353

19 Closing Remarks

20 Douglas Throckmorton, MD 370

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1 P R O C E E D I N G S

2 (8:37 a.m.)

3 DR. THROCKMORTON: Good morning, everybody.

4 If you could sit down we'll go ahead and get

5 started. Today, we have a busy two-day meeting

6 here.

7 My name is Doug Throckmorton. I am the

8 deputy center director at the Center for Drugs, and

9 I've met many of you at some of the other meetings

10 we've had related to the opioids epidemic in the

11 past. Welcome to you again today.

12 Very busy, very important two-day meeting

13 here to talk about the place that education has,

14 especially the place that federal education has in

15 addressing the opioids crisis that I know that we

16 are all very familiar with and all committed to

17 doing something to address that that's meaningful,

18 that makes a real difference.

19 The two days here are particularly exciting

20 for me because of the broad range of groups that we

21 have here. Mary tells me that there are 25

22 organizations at the state federal level, consumer
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1 advocacy groups, and from state and local, medical

2 boards, pharmacy boards, and the like, all

3 scheduled to talk at one part of the meeting or the

4 other in the next couple of days. In addition,

5 from the federal space, we have representatives

6 from almost the entire range of agencies that are

7 working in this area CDC, CMS, SAMHSA, NIDA, FDA

8 obviously. I'm probably missing -- oh, DEA is

9 going to be coming as well.

10 So a really broad range of voices, something

11 that is really important for us as an agency, as we

12 decide where to go next in this area of federal

13 education. And then, decide how to do it as best

14 we can, to do the most effective job at educating

15 and training healthcare professionals in this

16 terribly important area.

17 Our intent is to listen closely and to take

18 the things that you all say seriously. I am going

19 to be planning on summarizing what we've heard at

20 the end of the second day. I hope we're going to

21 have a vigorous discussion, one that we will be

22 able to make important use of.
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1 Before I turn the podium over to

2 Dr. Woodcock, I have some housekeeping things I

3 have been asked to remind people of. One, please

4 turn off or silence your phones. There is a one-

5 hour lunch break. The restrooms are down the hall

6 and to the right, important things like that.

7 The open public hearings are scheduled each

8 day. If you are interested in speaking, go to the

9 registration table. That's right outside and let

10 them know, and we will make time for you.

11 There is a docket that has been set up for

12 this. That docket will remain open until July

13 10th. As you'll hear, we are hoping that docket is

14 going to be useful for you for giving us some

15 additional information, things that we should take

16 into consideration.

17 A transcript of the meeting will be posted

18 within 30 days of the meeting. A webcast is being

19 done, and that will be archived for later viewing.

20 Because there is a webcast, if you make comments,

21 please make them into a microphone so they can be

22 captured and available for people listening on the
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1 Web. And then finally, again, thank you very much

2 for participating in this. We are taking this very

3 seriously, and appreciate all of your time and

4 attention to this matter.

5 With that, I am going to turn the podium

6 over to Dr. Woodcock, who is the head of the Center

7 for Drug Evaluation and Research to give us some

8 opening remarks.

9 Janet?

10 Opening Remarks – Janet Woodcock

11 DR. WOODCOCK: Thanks Doug, and good

12 morning, everyone. I am very happy to be here and

13 kick this meeting off. To start, I would really

14 like to step back a little bit and say where we

15 are, we have come from, how did we get to this

16 place.

17 Well, right now, as everyone in this room

18 knows very well, there is an epidemic of use of

19 prescription opioids and related substance abuse.

20 And FDA has been executing an action plan that we

21 published a year ago on a large number of steps we

22 are trying to take to help control this.
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1 I think everyone agrees that this can't be

2 done by one entity alone. That's why there's so

3 many different groups represented here. It is

4 going to take concerted effort at the federal,

5 state, local, professional society level to manage

6 this.

7 But FDA's part of the plan, we try to

8 decrease exposure, overall exposure to prescription

9 opioids. We've been approving alternative pain

10 medications, so that there are other tools that

11 prescribers have when someone presents with pain.

12 We've been stressing education under our

13 REMS program and offering educational programs for

14 several years, and that's been very successful. A

15 large number of healthcare professionals have taken

16 CME programs, educational programs, under this.

17 We also have been trying to decrease the

18 non-medical use of opioids by approving

19 abuse-deterrent formulations of various types, and

20 that is an experiment that we still are assessing

21 how effective various abuse-deterrent formulations

22 might be. We view that we have version 1.0, maybe
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