CBI Scene Blog

Why Should ADFs (Abuse Deterrent Formulations) Be Mandatory?

Posted by Daniel L. Cohen on May 19, 2015 1:39:17 PM

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Prescription opioid abuse is at a crisis point that demands our immediate attention. An estimated 16,000 lives are lost each year due to prescription opioid abuse. That’s 46 people every single day of the year. In 2013, only 16% of Americans believed that the United States is making progress in its efforts to reduce prescription drug abuse. And 37% of Americans say the country was losing its grip on the problem of prescription drug abuse. Action is needed now before more lives are lost and more families are impacted.

Prescription drug abuse is a complex issue that requires multiple approaches to treat. While there are many good, solid efforts underway through law enforcement, education, rehabilitation and regulation to curb the abuse of prescription drugs, the problem continues to grow. One technology that will that can have a big impact on the problem, but is not yet widely adopted is Abuse deterrent formulations (ADFs), which offer a meaningful and new approach to help fight this devastating epidemic. Today’s ADFs technology is already helping prevent the crushing, snorting and injecting of painkillers that abusers use seeking an immediate high.  But too few drugs – only a handful representing less than 3 % of total sales – contain an ADF. The widespread adoption of ADF is a critical element in the fight against prescription drug abuse, but it needs to become mandatory in all opioids and stimulants that have a high potential of abuse.

The Abuse Deterrent Coalition was created to serve as a forum for Abuse Deterrent Formulation Technology manufacturers, patient & issue-advocacy associations and pharmaceutical manufacturers to educate the public, policy makers and the FDA on the importance of ADF technologies. The coalition provides a unified voice for legislative and regulatory initiatives that support required use of abuse deterrent formulations. And not just opioid painkillers, but abuse deterrent formulations can also play a positive role in combating the growing problem of Schedule II stimulant prescription drug abuse, such as ADD and ADHD medication, especially among college students.

Thirty-one states currently are considering some form of legislation requiring drugs with abuse deterrent formulations -- but a patchwork state-by-state solution for drugs sold across the country will not effectively curb this national crisis. That is why Congress must introduce federal legislation requiring the FDA to mandate ADFs in all Schedule II drugs by a date certain. Mandatory legislation, that clearly protects patient access to needed therapies and makes it harder for abusers to misuse today’s medications will provide the necessary incentives for manufacturers to continue to research and develop – and most critically, deploy -- more abuse deterrent technologies as part of the solution to the prescription drug abuse crisis in this nation.

A comprehensive approach is needed to combat prescription pain medication abuse while still maintaining access for pain patients who need them. ADFs are an available today and will be a valuable tool in that effort – if only the FDA and/or Congress require that this technology be used.  Please take a look at the Abuse Deterrent Coalition website and help spread our mission to save lives.

 

Dan Cohen

Forum Chair- Abuse Deterrent Coalition

Abusedeterrent.org  

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Daniel L. Cohen

Mr. Cohen is the consulting Head of North American Government Relations, responsible for public policy and governmental regulatory relations in Washington, D.C. and Canada for Grünenthal USA, a biopharmaceutical company which develops and commercializes Abuse Deterrence Formulations (ADF) for opioid analgesics.  He also serves as the Forum Chair of the US Abuse Deterrent Coalition, a “talk group” of over 20 ADF manufacturers, patient advocates and related organizations seeking to expand access to ADF technologies.

In addition, he serves as Senior Vice President for Government Relations, External Affairs and Health Policy with EnteroMedics, an early-stage medical device company, where he is part of the senior management team that led the successful 2015 FDA approval of the first new obesity medical device for consumer health since 2001

He is the Vice Chairman of the Board of Directors for the MedStar National Rehabilitation Hospital Network, a 129 bed, $105m annual revenue specialty hospital and is a member of the Quality, Safety and Patient Affairs subcommittee of the MedStar Hospital Board of Directors. 

Formerly, as Managing Director/Global Government Relations for The Depository Trust & Clearing Corporation, he was responsible for leading government relation functions, including formulating the overall strategy, representing the DTCC before the U.S. Congress, European Parliament, Asian governments and their respective regulatory bodies. 

Cohen has served in Washington since 1979 and has experience in various senior-level government relations positions.  Prior to his current roles, Cohen served as a senior executive with several medical device and healthcare corporations, including US Oncology/McKesson, the largest U.S. national oncology physician provider network, and Inamed/Allergan, a medical device/aesthetics company.  In those positions, he established Washington, D.C. and global government relations functions, led the companies’ legislative policy and governmental regulatory relations program and was also responsible for managing public policy, investor relations, and political functions at the state, national and global levels.

Prior, Cohen was a principal at Loeffler, Jonas & Tuggey, LLP, where he managed several clients in financial services.  Earlier in his career, Cohen was the senior legislative liaison for the American Israel Public Affairs Committee (AIPAC), an Alternate Delegate of the United States to the United Nations, US Chairman of an international NGO and earlier served as Legislative Director for two Congressmen on Capitol Hill and in various campaign positions at the Presidential, Congressional, State and local levels.

Addition Boards of Directors include the U.S. Congress chartered “Congressional Award Foundation,” the Business-Government Relations Council and a just completed term as Chair of the College of William & Mary PFC council.

Cohen earned a bachelor’s degree in Sociology in 1978 from Willamette University and received a master’s degree in International Affairs from Georgetown University in 1985.

Topics: Compliance