US DoJ Memos May Hint At Enforcement Stepdown

The US Department of Justice has ordered its attorneys to ask for the dismissal of more whistleblower cases, and to avoid basing civil enforcement actions solely on guidance documents. Both could lead to fewer enforcement actions against device manufacturers.

LISBON, PORTUGAL - December 9, 2014: Photo of the United States Department of Justice (DOJ) homepage on a monitor screen through a magnifying glass.

Two recent memos from the US Department of Justice indicate new policies that could lead to a lighter touch for device-industry enforcement.

The first memo, dated Jan. 10, says that government attorneys should consider dismissing whistleblower False Claims Act cases when the government declines to intervene. Ongoing FCA cases can require government resources and impede other enforcement actions even if the government has officially opted out of a case, Michael Granston, director of the commercial litigation branch of DOJ's fraud section, explains in the document

More from Legal & IP

More from Policy & Regulation

Tariffs Threaten Medtech Innovation And US Position As World Leader, Whitaker Tells Lawmakers

 

During his testimony before US senators on the impact of tariffs on critical supply chains, AdvaMed’s Scott Whitaker said the Trump tariffs could jeopardize America’s preeminence in medtech. Other industry experts echoed similar concerns.

Califf Warns Progress May Be In Danger Due To ‘Decimated’ FDA Staff

 

In Vivo spoke to the previous commissioner of the US FDA about recent ongoings at the agency, and where he believes policy should be directed for patient and industry benefit.

What’s A Diagnostic? WHO Wants To Know

 
• By 

The World Health Organization is seeking input from stakeholders to create an official definition of the term ‘diagnostics.’ This initiative follows a 2023 resolution aimed at enhancing global diagnostics capacity; the definition, it is hoped, will help drive the creation of effective health policies. Comments will be accepted until 23 May.