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Key Stakeholders Gather This Fall to Discuss Abuse-Deterrent Formulations, Regulations and Policies

Dan Cohen, Chair, ABUSE DETERRENT COALITION
Dan Cohen, Forum Chair,
Abuse Deterrent Coalition

This guest blog post is written by Dan Cohen, the Forum Chair of the Abuse Deterrent Coalition and speaker at the 3rd Human Abuse Liability & Abuse-Deterrent Formulations conference, which takes place in Arlington, VA this November 2-3. 

The prominence of Abuse Deterrent Formulations (ADF) in the public policy debate has never been greater.  This fall is no exception as we are now at yet another critical juncture for the ADF sector, with critical meetings in guidelines, regulations and policy in active discussion.  At the end of October, the FDA will hold a public meeting on Draft Generic Guidelines to create a pathway for ADF products.  The Institute for Clinical and Economic Review – ICER — has just issued its draft pricing report and invited pharmaceutical companies to provide input regarding the organization’s “uptake assumptions.”  Health Canada has scheduled a November “Summit” to discuss ADF/Opioid policy.  New technologies, particularly those focusing on IR products, are on the horizon.

Simultaneously, we see lawmakers in 37 states have reviewed, explored and/or adopted legislation related to ADF and formulary guidelines.  In New York, there is recent legislation adopted that is waiting Governor Cuomo’s support to mandate insurance reimbursement for ADFs.

The United States indicated it would host the first annual “North American Dialogue on Drug Policy.”  Scheduled for late October, this tri-country meeting is designed to exchange information on drug trends, including illicit opioid use, in the North American hemisphere.  The dialogue will be an opportunity to discuss each country’s approach to addressing the heroin and fentanyl crisis plaguing our communities, including our respective approaches to public health interventions.

As Forum Chair of the Abuse Deterrent Coalition, I believe it’s important for the abuse deterrent business community to coalesce, comment and concentrate on our common agenda to advance ADF and build on our shared goals.  We should be encouraged by our progress, acknowledge that most of the work remains in front of us and remain optimistic about our technology-driven future.

posted in Drug Safety, Pharmaceutical
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