6 drug firms under investigation over alleged roles in opioid crisis | MiMedx settles fraud charges | Some Democrats caution against Medicare for All proposal
November 27, 2019
FDLI SmartBrief
News for the food and drug law community
Drugs & Biologics
6 drug firms under investigation over alleged roles in opioid crisis
At least four drugmakers and two drug distributors are under investigation by federal prosecutors for possible violation of the Controlled Substances Act on allegations they helped fuel the opioid crisis through their management of opioids. Amneal Pharmaceuticals, Johnson & Johnson, Mallinckrodt and Teva, and drug distributors McKesson and AmerisourceBergen have already received subpoenas, and more companies are expected to receive subpoenas in the coming months, a source says.
Reuters (11/26),  Becker's Hospital Review (11/26),  The Wall Street Journal (tiered subscription model) (11/26) 
MiMedx settles fraud charges
MiMedx, together with former CEO Parker Petit, former COO William Taylor and former CFO Michael Senken, agreed to pay $1.5 million to settle allegations that the company misstated the firm's revenues and misled investors. The complaint involves what investigators say were undisclosed side arrangements with five distributors.
MassDevice (Boston) (11/26) 
Some Democrats caution against Medicare for All proposal
Some members of the Democratic Party are shifting away from the push for Medicare for All particularly in states where it could hurt them politically. Sens. Bernie Sanders, I-Vt. and Elizabeth Warren, D-Mass., continue to tout the plan but other Democrats are not in favor of it and say it may be a political liability.
The New York Times (tiered subscription model) (11/26) 
Medical Devices
Roche hit with $137M verdict in patent case
A federal jury hit Roche with a $137.3 million verdict for infringing three laboratory system patents covering electrochemiluminescence technology. "There is no impact on our ability to offer and distribute our Cobas e/Elecsys products to customers, neither in the US nor in ex-US markets," Roche said, noting it was disappointed by the outcome.
360Dx (tiered subscription model) (11/26) 
EU medtech group accuses governments of lack of MDR/IVDR preparation
MedTech Europe said that the European government authorities lack preparation for the upcoming Medical Device Regulation ruling. "As we have maintained throughout the regulations' transition periods to-date, this incomplete implementation by the EU member states and European Commission threatens the continuity of patient access and care, both in Europe and in the more than 100 countries around the world that rely on the EU CE marking of medical technologies," according to the medtech trade association.
MassDevice (Boston) (11/26) 
Class I devices upclassified to higher risk class under MDR
The European Union has proposed to include all class I devices on the four-year extension in the EU market before they must be fully compliant with the Medical Device Regulation. Member states are being given eight days to consider whether their class I-classified devices under the MDR are eligible for the upgrade.
Medtech Insight (free registration) (11/26) 
ACS X12 urged to include medtech identifiers on insurance claims forms
The ACS X12 standards body was urged by some organizations to include medical device identifiers on insurance claims forms. "X12's proposal to add device identifiers to claims is a critical next step to using real world evidence to assess the safety and performance of artificial joints, cardiac devices, and other medical implants," says Ben Moscovitch of The Pew Charitable Trusts.
MedTech Dive (11/26) 
All flavored e-cigarette products banned in NYC
The New York City Council passed an ordinance banning all flavored e-cigarette and vaping product flavors except tobacco in a 42-2 vote Tuesday. "With this vote, the City Council is moving to ban the fruity, minty, candy-like flavors of e-cigarettes, which were clearly designed to appeal to young people in the first place," City Council Health Committee Chair Mark Levine said.
CNBC (11/26) 
Food and Drug Law Institute (FDLI) Highlights
A Practical Guide to Bringing a Dietary Supplement to Market | Dec. 19 | 2-3:30 PM | Live Webinar
A Practical Guide to Bringing a Dietary Supplement to Market | Dec. 19 | 2-3:30 PM | Live Webinar
Tune in to hear from speakers on what it takes to bring a dietary supplement to fruition, regulatory considerations, and the uncertainties that may arise in this space. Panelists will also discuss labeling basics and claim substantiation, manufacturing processes and practices, and best practices to avoid being on FDA's radar. Register now.
Submit a topic using FDLI's webinar portal
Submit a topic using FDLI's webinar portal
Have a subject you'd like to learn more about? FDLI invites food and drug law community stakeholders to submit a topic proposal using our webinar portal. Ideas related to all FDA-regulated industries are welcome! Webinars provide timely education in a convenient format, are typically 90 minutes, and offer downloadable slides and interactive features such as attendee polling and Q&A. Share your ideas.
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