Steve Pasierb to Commissioner Hamburg: Do Not Approve New Opiate for Marketing

Steve Pasierb, President and CEO of The Partnership at Drugfree.org, reached out to Margaret Hamburg, M.D., Commissioner of Food and Drug Administration, this week to urge her not to approve Zohydro ER for marketing without requiring it to have tamper-resistent features. His letter is below.

Dear Commissioner Hamburg:

I am writing to you today regarding the December 7th meeting of the Anesthetic and Analgesic Drug Products Advisory Committee.  At this meeting, the Committee is scheduled to discuss the risks and benefits of the new drug application for Zohydro ER, an extended release opioid analgesic.  As an organization dedicated to significantly reducing medicine abuse – including the widespread consumer behavior of intentional abuse of opioid products -- The Partnership at Drugfree.org urges the Committee not to approve Zohydro ER for marketing without requiring it to have tamper-resistant features. 

The United States is facing an epidemic of prescription drug abuse. Opioid pain relievers now have the unwelcome distinction of being responsible for more overdose deaths each year than heroin and cocaine combined.  And due to the increase in overdoses from prescription pain medicine, we have also seen the number of drug overdoses outpace deaths from car crashes. 

To reverse this tragic trend, The Partnership launched The Medicine Abuse Project, a multi-year communications and action campaign to inform parents, educators, healthcare providers and communities about the dangers of medicine abuse and motivate them to take action by (1) talking to the teens in their lives about this deadly behavior and (2) securing and disposing medicine in their home.  The Medicine Abuse Project aims to reduce the number of teens abusing medicine by half a million in five years. 

As part of the Project we launched MedicineAbuseProject.org, a microsite that contains relevant materials to equip parents and grandparents, educators, healthcare providers and community leaders to take action in their personal and professional lives to address this problem.  We have publicized this information through a wide range of public relations efforts and had more than $10 million worth of public service announcements on this subject running during the month of September 2012.  Additional awareness efforts -- including a project with the Food and Drug Administration to educate healthcare professionals about prescription drug abuse as well as steps they can take to screen, intervene and refer addicted patients to treatment – will continue over the course of the next five years.

While we believe that the education and empowerment actions that we are taking through The Medicine Abuse Project will be successful in effecting change, we know
that we cannot solve this problem alone. One of the other important factors that will help drive down abuse of prescription medication is ensuring that as many medications as possible – particularly opiate analgesics which have proven to be the most deadly – have abuse deterrent properties.  As long as opioid products that can easily be crushed and abused are widely available, our job preventing this behavior is made more difficult.

While the results from the reformulation of OxyContin and Opana ER are still developing, what we are seeing is quite encouraging.  The new tamper-resistant formulations of both of these products are being abused less, according to reports from Poison Control Centers and drug treatment facilities.  If all extended-release opiate products were required to incorporate tamper-resistant technology, we believe that we would start seeing a beneficial societal impact of less abuse of opioid products, fewer prescription drug overdoses, and fewer deaths.  As a public policy matter, we should all be encouraging companies to “retrofit” their current products so that they are more difficult to abuse.  And we certainly should not be approving any new opiates without these protections.

Prescription medicines are far too easy to abuse and, because these products are prescribed by a health care professional, have neither the stigma nor the perception of risk associated with street drugs.  While The Partnership is working through The Medicine Abuse Project to educate the general public about the true risk of abusing these products, we need the Food and Drug Administration to ensure to the extent possible that these medications are more difficult to abuse.

Thank you for your attention to this important matter. 

Sincerely,

Stephen J. Pasierb

President and CEO

The Partnership at Drugfree.org