Pathways' Pick of the Week: DoJ Branch Dissolution Raises Enforcement Questions

article image
ARTICLE SUMMARY:

The Consumer Protection Branch of the US DoJ is being disbanded. Excerpted from Pathways’ Picks May 7: Tarver Speaks, CMS Seeks Compromise, Switzerland Eyes FDA.

The Consumer Protection Branch (CBP) of the US Department of Justice is being disbanded, according to multiple reports in recent weeks. That raises questions for FDA enforcement activities in the device arena, affirmed William McConagha, a partner at law firm Latham & Watkins, during a May 2 MDMA panel. CBP historically is the DoJ arm that engaged with FDA and pursued FDA-related civil injunction cases, as well as criminal cases, including those stemming from enforcement actions against device companies, McConagha, a former FDA associate chief counsel, explained. The dissolution of CPB, he noted, “creates enormous uncertainty.” However, he cautioned, that doesn’t mean FDA will not be going after cases it views as legitimate fraud. “The FDA Office of Chief Counsel remains largely intact at the moment and continues trying to work with the agency” on litigation and referring cases to the Justice Department, the attorney noted.

Continue reading Pathways’ Picks here.
×



Articles from David Filmore:

Regulatory & Reimbursement

Docs of the Month: South Korea Supports New Digital Products Law

South Korea’s Digital Medical Products Act took effect earlier this year. Now the country’s regulatory authority is working to fully implement the law, including with the release of almost a dozen regulations and guidance documents over the past two months.

Read Article