Testimony of Shruti Kulkarni


On Behalf of the Center for Lawful Access and Abuse Deterrence

Advisory Board Meeting of Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee


March 14, 2017


Good morning. I am Shruti Kulkarni, and I am outside counsel to the not-for-profit Center for Lawful Access and Abuse Deterrence (CLAAD). Our organization works to reduce prescription drug fraud, diversion, misuse, and abuse while advancing consumer access to high-quality health care.


CLAAD’s funders include treatment centers, laboratories, and pharmaceutical companies, and are disclosed on our website, claad.org.


Thank you for the opportunity to provide CLAAD’s input on the risk-benefit of oxymorphone products. The U.S. Food and Drug Administration (FDA) should require a product-specific Risk Evaluation and Mitigation Strategies (REMS) program for oxymorphone products so that the benefits of the medication continue to outweigh the risks.


As you know, opioid overdose is a public health epidemic in the United States. An estimated 4.3 million Americans abuse opioids each year.[1] At the same time, an estimated 25.3 million Americans experience persistent pain and have a legitimate need for treatment.[2] Opioids have been demonstrated to help manage pain when other treatments have not provided enough pain relief.[3] For some individuals, opioids are the best treatment for their pain.[4] In addition, oxymorphone is characterized by specific, pharmacokinetic and pharmacodynamics characteristics that make oxymorphone an important option for chronic pain treatment.


Given the unique needs of each patient, physicians need an array of treatment options at their discretion to individualize treatment, including access to FDA-approved medications, each of which has its own strengths, weaknesses, and risks.


CLAAD supports FDA’s use of REMS to manage the risks associated with medications and advance prescriber education. As you know, a REMS program mandates that manufacturers utilize tools to manage known or potential serious risks associated with certain drugs while also making these medications available to patients with unmet medical needs. REMS include, among other things, medication safety guides, patient package inserts, communications plans, Elements To Assure Safe Use (ETASU), and implementation systems used to monitor, evaluate, and improve application of ETASU. ETASU is the strictest category of REMS and may include restricted distribution systems, which ensure only specifically approved parties have access to a drug under strictly controlled conditions.


According to Food and Drug Administration Amendments Act of 2007, medicines carrying serious risks would be removed from the market altogether without ETASU, leaving certain patient populations without treatment. A class-wide REMS with ETASU already exists for extended-release and long-acting opioids (ER/LA).  


If the FDA deems that oxymorphone products have greater risks than other ER/LA opioids, then we encourage the FDA to require a product-specific REMS with ETASU for these products. This will allow FDA to mandate that manufacturers manage known or potential serious risks associated with these products while also maintaining access to these products for patients who need them.


Thank you again for this opportunity. Please contact CLAAD if we can be of service to you.




[1]Behavioral Health Trends in the United States: Results from the 2014 National Survey on Drug Use and Health,

Substance Abuse & Mental Health Servs. Admin., (Sept. 2015), http://www.samhsa.gov/data/sites/default/files/NSDUH-FRR1-2014/NSDUH-FRR1-2014.pdf.

[2] Americans Are in Pain: Analysis of Data on the Prevalence and Severity of Pain from National Survey, National Institutes of Health, https://nccih.nih.gov/research/results/spotlight/081515

[3]National Pain Strategy, U.S. Dep’t of Health & Human Servs, (Mar. 18, 2016), https://iprcc.nih.gov/docs/drafthhsnationalpainstrategy.pdf.