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CLAAD Letter of Support for FDA Commissioner to HHS Secretary

September 30, 2014

Contact: Kyle Simon
(202) 599-8435

Coalition of Health Care Organizations Expresses Support for FDA Commissioner in Letter to HHS Secretary Sylvia Mathews Burwell

WASHINGTON, DC, September 30, 2014 — A diverse group of organizations today expressed support for U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg following a call last week for new leadership at the agency. Twelve signatories, including a prescription drug abuse prevention organization, several patient advocacy groups, and a biotechnological company, sent a letter to U.S. Department of Health and Human Services (HHS) Secretary Sylvia Mathews Burwell urging her to express public support for Dr. Hamburg and her colleagues at the FDA. Click here to read the letter.

With the prescription drug abuse epidemic resulting in more than 16,000 overdose-related deaths in 2011,  the coalition commended the Obama Administration’s commitment “to advancing policies that balance the dual public health aims of reducing drug abuse and providing access to care.” The federal government’s balanced approach has been demonstrated by the FDA under Dr. Hamburg’s leadership through myriad initiatives, including:

• The agency’s issuance of draft guidance for pharmaceutical manufacturers to spur research into abuse-deterrent technology;
• FDA approval of a hand-held auto-injector that allows family members and caregivers to administer medication to reverse opioid overdoses;
• Approval and labeling of a second opioid pain medication with abuse-deterrent properties;
• FDA approval of a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioid medications incorporating measures to reduce risks and improve safe use of ER/LA opioid medications;  and,
• The agency’s adjustment of safety labeling for ER/LA opioid analgesics to “more effectively communicate to prescribers the serious risks … thus encouraging better prescribing, monitoring, and patient counseling practices.”

These 11 organizations that signed the letter were:

• Center for Lawful Access and Abuse Deterrence
• Alliance for Aging Research
• American Academy of Pain Management
• American Chronic Pain Association
• Center for Practical Bioethics
• Egalet Corporation
• Global Healthy Living Foundation
• National Fibromyalgia & Chronic Pain Association
• The Pain Community
• U.S. Pain Foundation
• Virginia Cancer Pain Initiative
• Zogenix, Inc.



About the Center for Lawful Access and Abuse Deterrence

CLAAD coordinates efforts to prevent prescription drug fraud, diversion, and abuse while advancing patient access to high-quality medical care. For more information, visit www.claad.org or follow CLAAD on Twitter at @claad_coalition.

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