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Results: 1-10 of 783

Two Enacted State Laws Permit Truthful Off-Label Promotion
  • Cooley LLP
  • USA
  • May 16 2018

Earlier this month, Tennessee House Bill 2220 (substituted for Senate Bill 2361) (Tennessee Law) was enacted, which provides, “A pharmaceutical


Boots on the Ground: PIL Task Force Targeting Opioid Providers in the War on Drugs
  • K&L Gates
  • USA
  • April 30 2018

Attorney General Jeff Sessions announced the creation of the Prescription Interdiction & Litigation (“PIL”) Task Force -- which Sessions described as


"Off-label" Cases Aren't Going Away - DOJ Sheds Light on Direction of Enforcement of Misbranding Rules Governing Medical Products
  • Venable LLP
  • USA
  • March 6 2018

On February 28, Ethan Davis, the U.S. Department of Justice's (DOJ) deputy assistant attorney general responsible for consumer protection, gave a


Breaking News: TH v. Novartis - California Supreme Court Recognizes New Tort Duties as Traditional Limits Slide into the Sea
  • Reed Smith LLP
  • USA
  • December 21 2017

We posted our 2017 "Worst 10 decisions" list a day too soon, because the California Supreme Court issued its anticipated decision in TH v. Novartis


PMA Preemption & Fraud by OmissionConcealment
  • Reed Smith LLP
  • USA
  • November 29 2017

As our PMA preemption scorecard makes clear, warning claims are preempted under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), because the


Off-Label Marketing Case Tossed
  • Reed Smith LLP
  • USA
  • September 29 2017

Implied Preemption. Off-label promotion. TwIqbal. They make up a core of our posts, yet we never seem to tire of them. Maybe our readers, especially


How Companies Should Prep for Enforcement Shift to State AGs
  • Foley & Lardner LLP
  • USA
  • August 23 2017

“Top Cop” is how every state Attorney General wants to be known. In reality, state AGs have far more authority for civil enforcement than they do for


The Past, Present, and Future of Government Regulation of Off-Label Communications - Part 4
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • August 14 2017

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent


PhRMA Comment on the FDA’s Proposed Off-label Rule: The Rule of Law is the Best Medicine
  • Reed Smith LLP
  • USA
  • July 25 2017

The FDA cannot get out of its own way on the issue of off-label communications. Its power to punish off-label promotion comes from an odd regulatory


Off-Label Use Gets Congressional Hearing
  • Cooley LLP
  • USA
  • July 11 2017

Tomorrow, the House Energy and Commerce Committee will hold a hearing tilted “Examining Medical Product Manufacturer Communications.” According to the