How Did We Get Here? Where are We Going?

Bob A. Rappaport, M.D. Director Division of Anesthesia, Analgesia and Rheumatology Products Center for Drug Evaluation and Research Food and Drug Administration
March 3, 2009 FDA White Oak Campus, Silver Spring, MD

REMS for Opioid Analgesics:

Scope of the Problem

2000: first reports of widespread OxyContin abuse Label changes Advisory Committee meetings Risk management plans for most ER opioids 2009: prescription opioid abuse and misuse continues to grow

Numbers (in Millions)

35 30 25 20

National Survey on Drug Use and Health (NSDUH) Nonmedical Pain Reliever Use, Age 12 or Older: 2002 and 2007
(13.3%+) (12.6%) 33.1+
29.6

2002

2007

(4.7%)
15 11.0 10 5 0

(5.0%+)
12.5
+

(1.9%)
4.4

(2.1%)
5.2
+

Lifetime Use

Past Year Use

Past Month Use

Difference between this estimate and the 2002 estimate is statistically significant at the .05 level. 4

National Survey on Drug Use and Health (NSDUH) Past Year Pain Reliever Dependence or Abuse and Treatment, Aged 12 or Older: 2002 and 2007
Numbers (in Thousands)

1,800 1,600 1,400 1,200 1,000 800 600 400 200 0

1,509

1,707

2002

2007

564 360

Past Year Nonmedical Pain Reliever Dependence or Abuse

Received Treatment for Pain Reliever Problem During Last Treatment Visit, within Past Year
5

+ Difference between this estimate and the 2002 estimate is statistically significant at the .05 level.

National Survey on Drug Use and Health Source of Pain Relievers for Most Recent Nonmedical Use, Past Year, Users Aged 12 or Older: 2007
Source Where Respondent Obtained
Bought on Drug Dealer/ Internet 0.5% Stranger More than 4.1% One Doctor 2.6%

Source Where Friend/Relative Obtained

Other 1 4.2% More than One Doctor 2.9% Free from Friend/Relative 6.6%

One Doctor 18.1%

Free from Friend/Relative 56.5%

Bought/Took from Friend/Relative 14.1%

One Doctor 81.0%

Bought/Took from Friend/Relative 5.9% Drug Dealer/ Stranger 1.8% Bought on Internet 0.1% 6

Other category includes: "Wrote Fake Prescription, "Stole from Doctors Office/Clinic/Hospital/ Pharmacy," and "Some Other Way. "Note: Totals sum to <100% due to rounding and suppressed estimates.
1

Other 1 1.8%

Its Time to Take Action

Prescription opioids are at the center of a major public health crisis of addiction, misuse, abuse, overdose and death The current strategies for intervening with this problem are inadequate The risks must be addressed We must act We will begin the process of improving the risk management strategy for these products now
7

Its Time to Take Action

New authorities granted under FDAAA: we will now be implementing Risk Evaluation and Mitigation Strategies (REMS) for a number of opioid products We recognize the challenge We expect all companies marketing these products to work with us to get this done expeditiously If not, we cannot guarantee that these products will remain on the market
8

Finding a Balance
Adequate pain control is essential to good medical practice and mandated by various authorities Pain patients need access to potent opioid drug products Addiction and death due prescription opioids continue to increase We must find a way to work together to achieve our goals of maintaining access while reducing abuse, misuse, addiction and overdose
9

FDA Plans
We will meet with other stakeholders (pain and addiction treating communities, pain and addiction patient advocacy groups, medical societies, pharmacists and pharmacy organizations, REMS designers/vendors) over the next few months We will convene a public meeting to discuss the design and implementation of REMS for opioid drug products in late Spring or early Summer
10

FDA Plans: After the Public Meeting

FDA will evaluate the input we have received Additional meetings may be necessary including, possibly, an advisory committee meeting When we determine we are ready to do so, we will finalize the content of the REMS And we will issue REMS letters
11

FDA Plans: After the Public Meeting

Issuing REMS letters will start a FDAAA mandated response clock Final REMS approval and implementation occurs per required schedule Post-approval evaluation as per the statute

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Where Do We Go From Here?

We need your cooperation to put together a balanced, effective program, as quickly as possible We urge you to work together to create a single program, so as to not overwhelm the health care system It is essential that we achieve our goals:
Maintain access to opioid analgesics for legitimate patients, and Reduce the misuse, abuse, addiction and overdose deaths associated with these products
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