DOJ Enforcement: Talking With US FDA Is Not Enough To Get Credit For Self-Disclosure
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.
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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.
The nine drug manufacturers with products selected for Medicare drug price negotiations have agreed to participate in the program. Seven of them now have pending suits challenging the Inflation Reduction Act program with Novo’s recent complaint, which objects to the aggregation of its insulin products.
Drug manufacturers will have to participate in the Medicare drug price negotiation process for the foreseeable future. Judge Newman's finding that participation in Medicare is voluntary could defeat constitutional challenges to the program and have an impact on other cases.