For Immediate Release
January 18, 2017
James T. Boffetti, Senior Assistant Attorney General
Chief, Consumer Protection Bureau
Attorney General Joseph A. Foster today announced that his office has brought an enforcement action under the state's Consumer Protection Act against the makers of a powerful sublingual fentanyl spray product called Subsys. Insys Therapeutics, Inc., a Delaware corporation headquartered in Chandler, Arizona, aggressively marketed its brand name opioid, Subsys, a sublingual fentanyl spray that, as an opioid pain medication, is classified as a Schedule II controlled substance. In January, 2012, the FDA approved Subsys for the management of breakthrough cancer pain in patients 18 years of age or older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
New Hampshire patients received more than 800 Subsys prescriptions and more than 100,000 units of Subsys during 2013 and 2014, making New Hampshire patients the recipients of the second most prescriptions of Subsys per capita in the country. The majority of the New Hampshire prescriptions were written by Christopher Clough, a physician assistant who was employed at PainCare, a pain clinic located in Somersworth.
Clough became a frequent speaker within the Insys Speaker Bureau and was described by a former Insys official as a crucial part of the Insys Speaker Bureau. Clough was paid a total of $44,000 for speaking at approximately 40 programs on behalf of Insys as he quickly became the highest prescriber of Subsys in New Hampshire and one of the top Subsys prescribers in the country. In a two-year span, Clough wrote more than 760 Subsys prescriptions, representing 84% of the Subsys prescriptions written in New Hampshire.
The Attorney General's investigation concluded that many of these speaking engagements were a scheme by Insys to provide payments to induce prescribers to write Subsys prescriptions. Some of these speaking programs did not include anyone who could actually prescribe the drug and were sham events that were mostly social gatherings at high-end restaurants attended by Clough's friends and members of the office staff at PainCare.
In 2014, the New Hampshire Board of Medicine brought a disciplinary action against Clough for his inappropriate prescribing practices. In 2015, the Board of Medicine banned Clough from managing chronic pain, prescribing Schedule II-IV drugs, and performing pain procedures. In December, 2016, the Board revoked Clough's license to work as a physician assistant.
Unlike other opioid manufacturers being investigated by the Attorney General, Insys Therapeutics was cooperative in producing documents in response to the Attorney General's subpoena and otherwise cooperated with the State's investigation. While disputing and not admitting any of the alleged facts put forth as a result of the Attorney General's investigation, the drug company has agreed to the terms of an Assurance of Discontinuance under the Consumer Protection Act to resolve the matter.
On January 18, 2016, the Attorney General accepted the terms of the Assurance of Discontinuance (see copy of Assurance attached,) the terms of which include:
Under the Assurance, Insys has paid the State of New Hampshire $2,900,000 for its collective violations of the Consumer Protection Act. Insys will also make a direct payment to the New Hampshire Charitable Foundation in the amount of $500,000, to be used for the purpose of preventing or remediating problems related to abuse, misuse, or misprescribing of opioid drugs in New Hampshire.
Attorney General Foster commented, "This settlement represents an important first step in our investigation of the marketing practices of opioid manufacturers. Understating or misrepresenting the addictive nature of opioids can and has led to addiction and, in far too many cases, overdose deaths in our state. It is important for this investigation to continue into the conduct of other opioid makers to assure that false and deceptive marketing practices have or will be stopped."
The investigation was conducted with the able assistance of outside counsel, Cohen, Milstein, Sellers &Toll, PLLC.
Given both the amount, strength, and nature of the Subsys prescriptions that were written by Christopher Clough while he was employed at PainCare, Attorney General Foster is issuing the following consumer alert:
Further questions regarding this press release or for assistance accessing New Hampshire's Prescription Drug Drop Box Initiative should be directed to Investigator Calice Ducey at calice.couchman-Ducey@doj.nh.gov (603-271-2066) or Senior Assistant Attorney General James Boffetti at email@example.com (603 271-0302).
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New Hampshire Department of Justice
33 Capitol Street | Concord, NH | 03301