Wednesday, 22 Jan 2020

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. (bit.ly/2PNaeFz)

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.

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

Add new comment

More Like This

QD Clinic - Dealing with Non-adherence

QD Clinic - Lessons from the clinic. Today’s clinic topic: Dealing with Non-Adherence in the Clinic.

NSAID Safety Guidelines

Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for acute or chronic arthritis, headache, visceral pain, postoperative pain, etc but come with a small but significant risk of serious adverse effects, including hypertension, cardiovascular disease, kidney injury and GI complications.

Poor Sleep Increases Risk of Cognitive Decline

The Journal of Neurology, Neurosurgery & Psychiatry reports there is moderate evidence that six sleep disorders (insomnia, fragmentation, daytime dysfunction, prolonged latency, rapid eye movement sleep behaviour disorder and excessive time in bed) significantly increases the risk of cognitive disorders.

Metanalysis of 51 previously published reports looked at sleep issues and cognitive health over time.

Rheumatologists Ranked #1 in Happiness (Again)

Medscape has reported the results of its 2020 annual physician survey, This year rheumatologists (60%), general surgeons (60%), public health and preventive medicine physicians, and allergists/immunologists are the "happiest" outside of work compared to other specialists, according to Medscape.

Lowest in happiness were internal medicine, critical care and neurology (44-48%).

Best Practice Recommendations in Musculoskeletal Care

A group of Western Australian clinicians have set out to assess current practices and proved guidance recommendations for high-quality care for the most common musculoskeletal (MSK) pain scenarios encountered by clinicians in emergency and primary care. They have promulgated 11 high-quality clinical practice guidelines (CPGs).