The report describes one company’s emphasis on boosting approvals for its highly addictive fentanyl drug.
U.S. Senator Claire McCaskill, the top-ranking Democrat on the Senate Homeland Security and Governmental Affairs Committee, has released the first product of her wide-ranging investigation into opioid manufacturers and distributors.
The report, "Fueling an Epidemic: Insys Therapeutics and the Systemic Manipulation of Prior Authorization," describes the emphasis Insys Therapeutics put on boosting approvals for its highly addictive fentanyl drug Subsys, even for inappropriate, off-label uses, and details an audio recording in which an Insys sales representative misidentified herself and used language designed to circumvent the prior authorization process, McCaskill's office reports.
While the FDA has only approved Subsys for the treatment of breakthrough cancer pain, an internal document obtained by McCaskill shows that Insys lacked measures to prevent its representatives from manipulating the prior authorization process and gaining approval to use Subsys for treatment of non-cancer conditions like back pain, fibromyalgia, and migraine headaches.
McCaskill has previously requested information related to sales and marketing materials, internal addiction studies, details on compliance with government settlements, and donations to third-party advocacy groups from major opioid manufacturers.
She recently expanded her investigation, requesting documents and information from opioid manufacturers Mallinckrodt, Endo, Teva, and Allergan, while requests to McKesson Corporation, AmerisourceBergen Corporation, and Cardinal Health, Inc., focused on their distribution of opioid products.