Regulatory Compliance & Ethical Standards Flashcards
7 cards from real CNPR practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Compliance & Ethical Standards flashcards as text
The FDA's MedWatch program is primarily designed to:
Answer: Collect voluntary adverse event reports from healthcare professionals and consumers
MedWatch is FDA's safety reporting program that allows healthcare professionals and patients to voluntarily report adverse events and product problems.
A pharmaceutical rep is asked by a nurse practitioner to leave samples of a product for patients who the NP will not personally supervise. According to PDMA, the rep should:
Answer: Leave samples since nurse practitioners have prescribing authority in many states
PDMA allows samples to be given to practitioners licensed to prescribe the drug, and nurse practitioners with prescriptive authority qualify in states where they have that authority.
Which of the following is a key distinction between an 'educational grant' and a prohibited kickback in pharmaceutical compliance?
Answer: Legitimate educational grants are provided without expectation of prescribing activity and go through an independent process
A legitimate educational grant is provided through an independent, arm's-length process with no strings attached to prescribing, while a kickback involves quid pro quo.
State-level 'aggregate spend' or 'gift ban' laws that restrict pharmaceutical company interactions with physicians are:
Answer: In addition to federal requirements and may be more restrictive than federal law
Many states have enacted their own marketing transparency and gift restriction laws that apply independently of and can be more stringent than federal requirements.
The term 'misbranding' as defined under the Food, Drug, and Cosmetic Act most directly applies to pharmaceutical promotion that:
Answer: Contains false or misleading labeling or promotional claims about the drug
Misbranding under the FDCA occurs when a drug's labeling (including promotional materials) is false, misleading, or fails to disclose required information.
When a pharmaceutical representative discovers that a physician they call on is under a corporate integrity agreement restriction for past fraud, the appropriate action is to:
Answer: Immediately consult compliance to determine whether interactions with this physician are permissible
Interactions with excluded or CIA-restricted individuals can create liability; compliance must be consulted to assess whether and how the relationship may continue.
The requirement for pharmaceutical companies to submit 'Dear Healthcare Provider' (DHCP) letters is typically triggered by:
Answer: Important new safety information such as a label change or market withdrawal
FDA may require or companies may issue DHCP letters to rapidly communicate important safety updates, label changes, or recall information to prescribers.