Mallinckrodt Statement on U.S. DOJ Subpoena Related to Opioid Products
Aug. 2, 2017
On Thursday, July 27, 2017, Mallinckrodt Pharmaceuticals received a subpoena from the U.S. Department of Justice (DOJ) seeking information specific to its promotional practices for and sales of EXALGO® (hydromorphone HCl) extended-release tablets, CII, Roxicodone™ (oxycodone hydrochloride) tablets USP, CII, XARTEMIS® XR (oxycodone hydrochloride and acetaminophen) extended-release Tablets, CII and any other opioid products manufactured, marketed and sold by the company. The company will cooperate fully with the DOJ on this matter.
As a company that currently manufacturers only generic and non-promoted branded opioids, Mallinckrodt and its leadership have been at the forefront in developing a comprehensive approach to preventing prescription drug diversion, misuse and abuse. For many years, Mallinckrodt has been a vocal advocate and leader in the fight for a prescription drug monitoring program in Missouri. To date, the company has purchased and donated more than 1.5 million drug deactivation pouches across the U.S. so families can safely dispose of unneeded medicines to prevent abuse and misuse – donating more than 400,000 in Missouri alone.
The company works 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; attacks drug theft through tracking devices in select Mallinckrodt drug bottles; and contributes testimony on behalf of prosecution in drug diversion cases. Mallinckrodt 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.
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