Mallinckrodt Statement on Missouri Attorney General Investigation
Aug, 30, 2017
As an expansion to an ongoing investigation, Mallinckrodt, along with six other opioid manufacturers, recently received a Civil Investigative Demand (CID) from the Office of the Missouri Attorney General concerning the sale, marketing, advertisement, promotion and distribution of opioids. Mallinckrodt today manufactures only generic and non-promoted branded opioids, which account for less than 10 percent of company sales, and the company ceased any marketing or promotion of opioids some years ago. We believe the company has acted and continues to act lawfully and responsibly.
We recognize that the opioid epidemic is a complex and confounding problem, and no one policy initiative or program will solve it. Mallinckrodt and its leadership have been at the forefront in developing a comprehensive approach to preventing prescription drug diversion, misuse and abuse.
Mallinckrodt's Work to Address Prescription Drug Abuse
Most recently, Mallinckrodt donated 50,000 medication disposal pouches to the State of Missouri for distribution through the Department of Health and Senior Services (DHSS). Mallinckrodt's donation helps provide Missouri families a safe and responsible medication disposal method, preventing misuse of leftover prescription medications. To date, Mallinckrodt has provided total donations of about 400,000 pouches in Missouri – a state we have called a home for 150 years –reaching hundreds of thousands of families in partnerships with organizations such as St. Louis College of Pharmacy, ACT Missouri and NCADA St. Louis. Nationwide, Mallinckrodt has provided donations of more than 1.5 million pouches to help combat the misuse of prescription pain medications, which we recognize is one of the top public health threats in the U.S. today.
For many years, Mallinckrodt has been a strong proponent of prescription drug monitoring programs (PDMPs) across the U.S. to provide prescribers and pharmacists with a valuable tool to track a patient's opioid prescription use. We've been a vocal advocate in Missouri and have led a coalition of groups to advocate legislation in the state to implement a PDMP.
We work with law enforcement to help prevent misuse and diversion, including by providing no-cost placebo tablets of Mallinckrodt opioids to officers and prosecutors for use in law enforcement operations, and contributing testimony, product testing and other information on behalf of the prosecution in drug diversion cases.
We also helped to found the Anti-Diversion Industry Working Group, a collective of leading manufacturers and distributors of pharmaceutical controlled substances coming together to collaborate and share best practices with the purpose of exceeding U.S. Drug Enforcement Administration obligations for opioid anti-diversion programs.
Mallinckrodt advocates for policies and initiatives that broaden access to opioid-sparing multimodal analgesia. With MMA, non-opioid treatments and techniques are the foundation of acute pain management. MMA combines two or more analgesic agents also or techniques that use different mechanisms to provide pain relief with fewer opioids. Mallinckrodt sponsors the Pain Stewardship ProgramTM for providers and clinical staff; the mission is to educate hospital stakeholders on multimodal analgesia (MMA)-based acute pain management to support improvements in in-hospital opioid use, length of stay (LOS) and satisfaction with treatment. The program provides evidence-based, educational pain management tools to help assess current hospital protocols and identify areas for improvement. The company's diverse product portfolio includes an intravenous, non-opioid analgesic used with multimodal pain management in hospitals.
To truly make an impact on opioid abuse and misuse, all stakeholders must work together to address this national problem in a comprehensive, thoughtful manner.
Mallinckrodt continues to work toward being a part of the solution. For more information, visit Mallinckrodt.com/solutions.
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and hemostasis products. The company's core strengths include the acquisition and management of highly regulated raw materials and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines and its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
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Senior Communications Manager
Chief Public Affairs Officer
Vice President, Government Affairs
Coleman N. Lannum, CFA
Senior Vice President, Investor Strategy and IRO
Daniel J. Speciale, CPA
Director, Investor Relations