Compliance and Ethics Flashcards

A company's compliance program is considered effective by the OIG (Office of Inspector General) when it includes which core element?

Answer: Written policies, procedures, and standards of conduct

OIG's model compliance program guidance identifies written policies, procedures, and standards of conduct as a foundational element of an effective compliance program.

In pharmaceutical sales, 'cherry-picking' refers to the unethical practice of:

Answer: Selecting only the most favorable clinical study data to present to physicians

Cherry-picking involves selectively presenting only favorable clinical data while omitting negative or contradictory studies, which is misleading and violates FDA regulations.

Under FDA regulations, a pharmaceutical advertisement is considered 'false or misleading' if it:

Answer: Makes implied claims not supported by substantial evidence

Advertising is false or misleading if it makes claims, including implied ones, that are not supported by substantial evidence or substantial clinical experience.

A pharmaceutical representative discovers their manager has been falsifying call records. The representative's ethical obligation is to:

Answer: Report the misconduct through the company's compliance hotline or ethics officer

Employees have an ethical and often contractual obligation to report misconduct through appropriate channels such as a compliance hotline or ethics officer.

Which of the following is a red flag that a physician's consulting arrangement with a pharmaceutical company may violate the Anti-Kickback Statute?

Answer: The consulting fee significantly exceeds fair market value for the services rendered

Consulting fees that exceed fair market value for genuine services may indicate that the excess payment is actually an inducement to prescribe, violating the Anti-Kickback Statute.

What does the term 'formulary status' mean in the context of pharmaceutical sales compliance?

Answer: Whether a drug is covered by a health plan's approved list of medications

Formulary status refers to whether a drug has been approved by a pharmacy benefit manager or insurance plan for coverage, affecting access and cost to patients.

A pharmaceutical representative who engages in 'off-label detailing' — promoting unapproved uses to physicians — risks which consequence for their company?

Answer: Corporate exclusion from federal healthcare programs and potential False Claims Act liability

Off-label promotion can result in corporate exclusion from Medicare/Medicaid and massive False Claims Act settlements, as demonstrated by multiple billion-dollar enforcement actions.