We continue to reiterate our efforts to be part of the solution to the opioid crisis by focusing on assisting patients and developing alternative pain medications in our research and development programs. The solutions to this serious national challenge require serious commitment by, and coordination between, governmental authorities, manufacturers, prescribers, patients and other stakeholders in the healthcare community. Encompassed in our desire to bring solutions is our continuing commitment to take responsibility for actions by our former employees and ensure high standards of integrity from our current employees.
Recent statements made in connection with the
- We continue to cooperate with the investigation by the
ArizonaAttorney General office, as we have done and will continue to do with each governmental authority.
- The allegations contained in the
ArizonaAttorney General’s complaint relate to former employees and physicians that are no longer associated with our Company or our speaker bureau.
- By many estimates, the national opioid crisis began more than a decade and a half ago. Our product, SUBSYS®, has been available since
March 2012. In 2016, SUBSYS accounted for less than 1,450 prescriptions in the State of Arizonawhen compared to over 4.7 million opioid prescriptions in the State of Arizonaduring the same period. In other words, in 2016, SUBSYS was less than 0.03% of all opioid prescriptions in the State of Arizona.
- A doctor is not permitted to prescribe, a pharmacy is not permitted to dispense, and a patient is not permitted to receive any Transmucosal Immediate Release Fentanyl (“TIRF”) product, including SUBSYS, unless each of them is enrolled in the
FDAmandatory TIRF Risk Evaluation and Mitigation Strategy (“REMS”) program. The TIRF-REMS program strives to limit the risk of abuse and misuse by restricting prescriptions to appropriate patients, preventing inappropriate conversions between medicines and educating patients, pharmacists and prescribers about potential for abuse, addiction and overdose of TIRFs, as well as the label for these products.
- Our compliance program has been under significant scrutiny for several years from governmental authorities as well as internal reviews conducted with the assistance of external experts and counsel. During this period, we have invested significant resources in establishing an effective compliance program with protocols designed to ensure compliant and ethical behavior. We recently completed a successful gap assessment into our compliance protocols and processes by an independent, global consulting firm. This assessment was voluntarily conducted with oversight from our Compliance Committee of the Board of Directors.
- Over the past several years, we have revamped our management and commercial organization. For example, 90% of the sales staff employed prior to 2014 are no longer with the organization. In addition, our management team has recently been fundamentally transformed with the replacement of key leadership positions in the commercial, operations and finance functions.
On behalf of almost 400 employees, across three facilities including a research & development laboratory and a fully functional manufacturing facility who work tirelessly to serve patients and address unmet patient medical needs, we believe it is important that public statements with respect to our Company fairly represent our continuing commitment to hold ourselves accountable and to operate with integrity.
SUBSYS® and SYNDROS™ are trademarks of
NOTE: All trademarks and registered trademarks are the property of their respective owners.
This press release contains forward-looking statements including regarding our (i) belief that it is not factually accurate to state that Insys has materially contributed to the opioid crisis in the
Lisa M. WilsonPresident 212-452-2793