Enforcement Climate Congressional Oversight U.S. Attorney’s Offices

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Presentation transcript:

Enforcement Climate Congressional Oversight U.S. Attorney’s Offices State AG, Inspector Generals quotas on fraud recoveries state False Claims Act Consumer Protection Off label enforcement will continue Whistleblowers to government competitive practices

Target v. Witness Counsel familiar with prosecutor Advice to Employees status of investigation/target/witness/custodian Advice to Employees the right not to talk to government agents Preserve documents have pre-existing retention policy issue litigation hold e-files Deal with disgruntled employees If something is wrong, cure it

Inquiries by Governmental Agents How do you answer these questions: With whom do you have contact? Marketing/Sales or Medical Education/Medical Clinical affairs Who writes the checks for CME? Who attends the meetings to develop CME? What is the nature of discussions regarding content of CME? Who from CME provider is there to discuss content? What was the nature of back and forth over content? Is there an agreement to have CME provider do something that company can’t do on its own?

Best Practices Is the FDA involved? Risk Continuum: Bring FDA program on your side create a record disclosure good compliance training education public health Risk Continuum: Real Firewalls; separate key people audits Compliance Officer to whom does CO report? Marketing Plans Sales Staff Legitimate purpose of information exchange CME - Disclosure of payments to speaker - List the pre-eminent faculty - Content: science v. promotion