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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 3 .

3%+) (12.4 (2.5 + (1. Age 12 or Older: 2002 and 2007 (13.7%) 15 11.9%) 4.2 + Lifetime Use Past Year Use Past Month Use + Difference between this estimate and the 2002 estimate is statistically significant at the .1%) 5.0 10 5 0 (5.6 2002 2007 (4.6%) 33.05 level.1+ 29.0%+) 12.Numbers (in Millions) 35 30 25 20 National Survey on Drug Use and Health (NSDUH) Nonmedical Pain Reliever Use. 4 .

within Past Year 5 + Difference between this estimate and the 2002 estimate is statistically significant at the .509 1.000 800 600 400 200 0 1.200 1.National Survey on Drug Use and Health (NSDUH) Past Year Pain Reliever Dependence or Abuse and Treatment. .400 1.05 level.707 2002 2007 564 360 + Past Year Nonmedical Pain Reliever Dependence or Abuse Received Treatment for Pain Reliever Problem During Last Treatment Visit.600 1. Aged 12 or Older: 2002 and 2007 Numbers (in Thousands) 1.800 1.

" and "Some Other Way.6% Source Where Friend/Relative Obtained Other 1 4.“ "Stole from Doctor’s Office/Clinic/Hospital/ Pharmacy.8% .0% Bought/Took from Friend/Relative 5.5% Stranger More than 4.9% Drug Dealer/ Stranger 1.National Survey on Drug Use and Health Source of Pain Relievers for Most Recent Nonmedical Use.6% One Doctor 18.5% Bought/Took from Friend/Relative 14.1% One Doctor 81. "Note: Totals sum to <100% due to rounding and suppressed estimates.8% Bought on Internet 0. Users Aged 12 or Older: 2007 Source Where Respondent Obtained Bought on Drug Dealer/ Internet 0. 1 Other 1 1.2% More than One Doctor 2.1% Free from Friend/Relative 56.9% Free from Friend/Relative 6. Past Year.1% One Doctor 2.1% 6 Other category includes: "Wrote Fake Prescription.

It’s Time to Take Action • Prescription opioids are at the center of a major public health crisis of addiction. abuse. misuse. 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 .

we cannot guarantee that these products will remain on the market 8 .It’s 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.

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. addiction and overdose 9 . misuse.

pharmacists and pharmacy organizations.FDA Plans • We will meet with other stakeholders (pain and addiction treating communities. 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 . pain and addiction patient advocacy groups. medical societies.

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

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 12 .

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. as quickly as possible • We urge you to work together to create a single program. addiction and overdose deaths associated with these products 13 . effective program.Where Do We Go From Here? • We need your cooperation to put together a balanced. abuse. and – Reduce the misuse.