In Midst of Overdose Epidemic, Agency Proposal Defies White House, Impedes Transition to Abuse-Deterrent Medications
September 10, 2015 – Washington, DC – The Center for Lawful Access and Abuse Deterrence (CLAAD) and 28 other not-for-profit and industry groups today sent a letter urging U.S. Health and Human Services (HHS) Secretary Sylvia Mathews Burwell to bring the Centers for Medicare and Medicaid Services (CMS) in line with Obama Administration policy supporting a market transition to abuse-deterrent medications.
An estimated 22,767 Americans die each year from overdoses involving prescription drugs. According to the Centers for Disease Control and Prevention (CDC), the prescription drug abuse epidemic has contributed to higher rates of heroin use and transmission of HIV and hepatitis C.
Abuse-deterrent medications incorporate technologies to make diversion, misuse, and abuse more difficult and less desirable. Recent studies have shown these medications to be effective in helping curb abuse.
The Obama Administration supports the development and use of abuse-deterrent medications. The White House Office of National Drug Control Policy, Food and Drug Administration, CDC, Substance Abuse and Mental Health Services Administration, National Institute on Drug Abuse, and Drug Enforcement Administration are all working in support of Administration policy on abuse-deterrent medications.
Under federal law, CMS has the authority to keep drug makers from charging the government more after making merely insignificant changes to previously available medications. CMS can require manufacturers of these “line extension” products to give the government a higher rebate. In 2012, CMS proposed a rule that subjects abuse-deterrent medications to this steeper line extension rebate. The rule is expected to become final in the coming weeks.
If enacted, the rule will thwart the market transition to abuse-deterrent medications by sending a signal to drug manufacturers that investing in making products safer does not pay off.
The proposed CMS rule “is not supportive and would seriously threaten industry incentive to create [abuse-deterrent formulation] products,” the letter read.
Organizations that joined CLAAD as signatories on the letter to Burwell include:
American Academy of Pain Management
American Society for Pain Management Nursing
Chronic Pain Research Group, University at Buffalo School of Pharmacy and Pharmaceutical Sciences
Community Anti-Drug Coalitions of America (CADCA)
Gatekeeper Innovation, Inc.
Grünenthal USA, Inc.
Healthcare Distribution Management Association
Inspirion Delivery Technologies
Interstitial Cystitis Association
Johnson & Johnson
National Fibromyalgia & Chronic Pain Association
National Hospice and Palliative Care Organization
Pain Connection-Chronic Pain Outreach Center, Inc.
Partnership for Drug-Free Kids
Reflex Sympathetic Dystrophy Syndrome Association
The Pain Community
Wisconsin Pain Initiative
U. S. Pain Foundation
The letter to Secretary Burwell can be found here.
About the Center for Lawful Access and Abuse Deterrence
CLAAD is a 501(c)(3) organization working to address the nation’s prescription drug abuse and heroin epidemic. CLAAD’s mission includes advancing consumer access to high-quality care for pain, addiction, HIV, hepatitis C, and other health conditions. Our National Prescription Drug Abuse Prevention Strategy, now in its fourth iteration, has been vetted and endorsed by more than 30 not-for-profit health and safety organizations. For more information, visit CLAAD.org and follow @CLAAD_Coalition on Twitter.