Friday, 06 Dec 2019

You are here

Mallinckrodt Receives SEC Subpoena

Reuters reports that Mallinckrodt Plc has received a subpoena from the U.S. Securities and Exchange Commission for documents related to the drugmaker’s lawsuit against the U.S. Department of Health and Human Services (HHS).

The lawsuit against the HHS and the Centers for Medicare and Medicaid Services was filed in May 2019 over changes in the calculation of Medicaid discounts for Acthar gel, the company's biggest money-spinner. (

Changes to the Medicaid rebate calculations could result in a near 10% hit to annual sales of Acthar, its costly treatment for multiple sclerosis and a rare infant seizure disorder, the company said in May.

The drugmaker on Tuesday reported a 20.8% fall in sales of Acthar gel for the quarter ended Sept. 27 due to the continued reimbursement challenges.

Mallinckrodt, among opioid manufacturers facing thousands of lawsuits seeking to hold them responsible for fueling an addiction crisis in the United States, is also grappling with an industrywide decline in generic drug prices and competition to two of its important drugs.

Against this backdrop, the company in August suspended plans to spin off its specialty generics unit, citing opioid litigation uncertainties, and also warned Acthar gel revenue was unlikely to exceed $1 billion this year.

Shares of the company, which in September agreed to sell its contract manufacturing unit to reduce debt, have slumped nearly 80% so far this year.

The author has no conflicts of interest to disclose related to this subject

Add new comment

More Like This

ACR Responds to CY2020 Medicare Physician Fee Schedule Proposed Rule

Rheumatology leaders commend CMS for proposing E/M code changes and urge agency to make additional changes to final rule.d

Parenteral Out-Performs Oral Weekly Methotrexate

A systematic review in PLOS suggests that parenteral MTX therapy is more successful than oral MTX in achieving optimal disease activity control. 

ACR Survey Shows Half of Patients Cannot Afford Treatments

Americans living with rheumatic disease face significant healthcare challenges, according to a national patient survey released this week by the American College of Rheumatology. More than 1,500 U.S. adults living with rheumatic disease responded to the survey, which asked a range of questions related to healthcare access, affordability and lifestyle. Key findings include that even though 90 percent of respondents reported having health insurance coverage, nearly 60 percent said they had difficulty affording their medications or treatments in the past year.

Medical Use of Cannabis in 2019

JAMA has published an overview of cannabis and its medical uses. Although nearly 10% of cannabis users in the United States report using it for medicinal purposes, there is insufficient evidence to support the use of medical cannabis for most conditions for which its use is advocated or advised. Nevertheless, there is increase in favoring the public availability of cannabis, largely for the management of more than 50 medical conditions.

Steroid Sparing Effects of Methotrexate and Mycophenolate in Uveitis

Patients with noninfectious uveitis (intermediate, posterior uveitis, or panuveitis) often require high dose corticosteroids and therefore may need steroid-sparing DMARD therapy. The FAST study investigated the corticosteroid-sparing effect of methotrexate or mycophenolate mofetil in adults with noninfectious uveitis.