DOJ Enforcement: Talking With US FDA Is Not Enough To Get Credit For Self-Disclosure
Executive Summary
Remediation of a problem with FDA is one factor the DOJ considers in assessing whether a company gets credit for self-disclosure of misconduct prior to a criminal investigation, but it wants companies to come directly to the department to divulge wrongdoing.
You may also be interested in...
Corporations Can Avoid Guilty Pleas, Compliance Monitors Under New DOJ Policies
Deputy Attorney General Lisa Monaco says the department will not seek a guilty plea when a corporation self-discloses and fully cooperates. Prosecutors to consider whether compensation systems provide incentives to promote compliance.
FDA Change In Bioequivalence Requirements Leads To Downgrade Of Accord’s Generic Tacrolimus
After agency tightened bioequivalence testing recommendations for tacrolimus products post approval, studies found Accord’s generic version of Prograf may deliver higher concentrations, leading agency to downgrade its therapeutic equivalence rating. No problems were found with five other tacrolimus ANDAs.
FTC Set To Take Enforcement Action Against Drugmakers Over Orange Book Patent Listings
Merger reviews could take into account sponsor's Orange Book behavior. FTC's statement does not detail what would make a patent listing 'improper' but the precedents from court cases against various sponsors should offer industry some guideposts.