Enforcement in Life Sciences Series:
Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers
About the Enforcement in Life Sciences Series
Recent settlements between the U.S. Department of Justice (DOJ) and a range of FDA-regulated drug and medical device manufacturers provide a snapshot of the DOJ’s enforcement focus. These settlements involve new DOJ theories of liability or new ways of evaluating long-standing industry practices, and may be harbingers of future DOJ enforcement activity. In this six-part series of client alerts, we take an in-depth look at the facts and legal theories in each case or set of cases, discuss what makes each novel, and consider the compliance implications for each.
FDA Letters Suggest Scrutiny Of Virus And Vaping Products law360.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from law360.com Daily Mail and Mail on Sunday newspapers.
(Nature Communications)
People with a previous rheumatoid arthritis diagnosis had a 30% to 50% lower risk of later developing Parkinson s, a nested case-control study showed.
(Journal of Parkinson s Disease)
(Movement Disorders)
(New York Times)
(Alzheimer s and Dementia)
Medicare data showed that payments for neurologist-prescribed brand name drugs jumped 50% from 2013 to 2017, but claims for these drugs rose only 8%. (Neurology)
(JAMA Network Open)
Military veterans with psychogenic or epileptic seizures had higher risks for death by suicide and suicide-related behavior than the general veteran population.
(Neurology Clinical Practice)
Silencing a gene involved in pain signaling reduced pain sensitivity in animal models and reversed chemotherapy-induced chronic pain in mice. (
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In keeping with family tradition, another Kardashian made headlines again in our food and drug world for the wrong reasons. And FDA’s Office of Prescription Drug Promotion (OPDP) was not likely amused to issue its third letter in 2021 – its first Untitled Letter this year for unlawful promotion.
1 In this case, OPDP took exception to a direct-to-consumer video of an interview with Khloe Kardashian, a paid spokesperson for a pharmaceutical company that marketed a prescription drug product for acute treatment of migraine with or without aura in adults. The video originally appeared on the television show,
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In this episode, AGG’s Food & Drug team leader, Alan G. Minsk, and team member, Genevieve M. Razick give an overview of FDA’s Office of Prescription Drug Promotion s (OPDP) enforcement of unlawful advertising in 2020.
Each month, we ll release a new podcast where different members of our Food and Drug practice and colleagues in other related life science teams will discuss issues and challenges they have encountered when assisting clients on business and legal issues.
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