MSL-BC EXAM | CERTIFICATION EXAM FOR MEDICAL
SCIENCE LIAISONS VIA MEDICAL SCIENCE LIAISON
SOCIETY. (MSL-BC) | 2025/26 QUESTIONS WITH
COMPLETE SOLUTIONS.
PhRMA Code Answer - 1. voluntary code
2. last revised 2021
3. Ensure industry interactions with HCPs are professional exchanges designed
to benefit patients and to enhance the practice of medicine
4. Based on the principle that a HCPs care of pts should be based solely on each
pt's medical needs and the HCP's medical knowledge and experience.
PhRMA's Goals Answer - 1. Inform HCPs about risks/benefits of products for
appropriate pt use
2. Provide scientific and educational info
3. Support medical research and education
4. Obtain feedback and advice via consultation with medical experts
PhRMA Code Section 2: Meals Answer - (a) modest as judged by local
standards; (b) not part of an entertainment or recreational event; (c) provided
in a manner conducive to informational communication.
**should also be limited to in-office or in-hospital settings, significant
others/guests are not appropriate.
Can't just Drop off food or give grab-and-go.
,Dinner programs okay if location is conducive to education, not too fancy, meal
is modest and incidental to informational session
No meals directly provided at CME events - however 3rd party
conferences/prof meetings where CME is only part of the meeting- company
can sponsor meal/reception
PhRMA Section 3: Entertainment & Recreation Answer - Companies shouldn't
provide any entertainment or recreational items (i.e. tickets to the theater or
sporting events, sporting equipment, or leisure or vacation trips) to any HCP
who is not a salaried employee of the company.
Shouldn't be offered regardless of (1) the value of the items; (2) whether the
company engages the HCP as a speaker or consultant; or (3) whether the
entertainment or recreation is secondary to an educational purpose.
PhRMA Code Dont's Answer - 1. no physical gifts - focus on education
2. no pens, mugs, product brochures, etc
3. occasionally items designed to help educate patients OR HCP if <$100
(medical book) or "starter kits"
4. Products of non-educational use are not allowed (pedometers, etc)
Nothing that does not advance disease tx or edu, nothing of personal benefit
(gas in car)
OIG Answer - Office of Inspector General
OIG Compliance Program Guidance (CPG) for Pharmaceutical Manufacturers
Answer - Compliance Program Guidance (CPG) was developed with goal of
preventing and reducing fraud and abuse in federal health care programs.
,The purpose of the compliance program guidance is to encourage the use of
internal controls to efficiently monitor adherence to applicable statutes,
regulations and program requirements
*set of guidelines only published in 2003
OIG Recommended Elements for Pharma CPG Answer - • Implementing
written policies and procedures; - Code of Conduct
• Designating a compliance officer and compliance committee;
• Conducting effective training and education; • Developing effective lines of
communication;
• Conducting internal monitoring and auditing;
• Enforcing standards through wellpublicized disciplinary guidelines; and
• Responding promptly to detected problems and undertaking corrective
action.
*CPG = Compliance Program Guidance
FDA's mission Answer - To Protect and promote public health. It is a consumer
protection agency AND a regulatory agency.
Assuring safety, efficacy, and security
Advancing public health
Speeding innovation
Assuring accurate, science-based information
What does the FDA not do? Answer - •Regulate physician or healthcare
provider practice
•Make recommendations for individuals (doctors, clinics, care facilities).
Dictate the prices of medications.
, What does the FDA not regulate? Answer - Advertising (except Rx-only drugs
and medical devices)
alcohol
Meat and poultry
herbal and dietary supplements
drugs of abuse
health insurance
grocery store water
What does the FDA regulate? Answer - food (including infant formula), drugs,
cosmetics and since 2009: cigarettes
MedWatch Answer - FDA's medical safety reporting program for medical
professionals and consumers
MedWatch Safety Alerts Answer - The FDA publishes safety alerts for FDA-
regulated products: Rx and OTC medications, Biologics (aka blood), medical
devices, combination products (nasal spray), infant formulas, special nutrition
products, cosmetics, food
FDA 3500 Answer - Med Watch program reporting form for healthcare
professionals
FDA 3500b Answer - MedWatch program reporting form for consumers
The Center for Devices and Radiological Health (CDRH) Answer - The FDA
center responsible for for overseeing the medical device program. The FDA
monitors reports of adverse events and other problems with medical devices
and when needed, alerts patients, health care providers, industry, and the
public.
SCIENCE LIAISONS VIA MEDICAL SCIENCE LIAISON
SOCIETY. (MSL-BC) | 2025/26 QUESTIONS WITH
COMPLETE SOLUTIONS.
PhRMA Code Answer - 1. voluntary code
2. last revised 2021
3. Ensure industry interactions with HCPs are professional exchanges designed
to benefit patients and to enhance the practice of medicine
4. Based on the principle that a HCPs care of pts should be based solely on each
pt's medical needs and the HCP's medical knowledge and experience.
PhRMA's Goals Answer - 1. Inform HCPs about risks/benefits of products for
appropriate pt use
2. Provide scientific and educational info
3. Support medical research and education
4. Obtain feedback and advice via consultation with medical experts
PhRMA Code Section 2: Meals Answer - (a) modest as judged by local
standards; (b) not part of an entertainment or recreational event; (c) provided
in a manner conducive to informational communication.
**should also be limited to in-office or in-hospital settings, significant
others/guests are not appropriate.
Can't just Drop off food or give grab-and-go.
,Dinner programs okay if location is conducive to education, not too fancy, meal
is modest and incidental to informational session
No meals directly provided at CME events - however 3rd party
conferences/prof meetings where CME is only part of the meeting- company
can sponsor meal/reception
PhRMA Section 3: Entertainment & Recreation Answer - Companies shouldn't
provide any entertainment or recreational items (i.e. tickets to the theater or
sporting events, sporting equipment, or leisure or vacation trips) to any HCP
who is not a salaried employee of the company.
Shouldn't be offered regardless of (1) the value of the items; (2) whether the
company engages the HCP as a speaker or consultant; or (3) whether the
entertainment or recreation is secondary to an educational purpose.
PhRMA Code Dont's Answer - 1. no physical gifts - focus on education
2. no pens, mugs, product brochures, etc
3. occasionally items designed to help educate patients OR HCP if <$100
(medical book) or "starter kits"
4. Products of non-educational use are not allowed (pedometers, etc)
Nothing that does not advance disease tx or edu, nothing of personal benefit
(gas in car)
OIG Answer - Office of Inspector General
OIG Compliance Program Guidance (CPG) for Pharmaceutical Manufacturers
Answer - Compliance Program Guidance (CPG) was developed with goal of
preventing and reducing fraud and abuse in federal health care programs.
,The purpose of the compliance program guidance is to encourage the use of
internal controls to efficiently monitor adherence to applicable statutes,
regulations and program requirements
*set of guidelines only published in 2003
OIG Recommended Elements for Pharma CPG Answer - • Implementing
written policies and procedures; - Code of Conduct
• Designating a compliance officer and compliance committee;
• Conducting effective training and education; • Developing effective lines of
communication;
• Conducting internal monitoring and auditing;
• Enforcing standards through wellpublicized disciplinary guidelines; and
• Responding promptly to detected problems and undertaking corrective
action.
*CPG = Compliance Program Guidance
FDA's mission Answer - To Protect and promote public health. It is a consumer
protection agency AND a regulatory agency.
Assuring safety, efficacy, and security
Advancing public health
Speeding innovation
Assuring accurate, science-based information
What does the FDA not do? Answer - •Regulate physician or healthcare
provider practice
•Make recommendations for individuals (doctors, clinics, care facilities).
Dictate the prices of medications.
, What does the FDA not regulate? Answer - Advertising (except Rx-only drugs
and medical devices)
alcohol
Meat and poultry
herbal and dietary supplements
drugs of abuse
health insurance
grocery store water
What does the FDA regulate? Answer - food (including infant formula), drugs,
cosmetics and since 2009: cigarettes
MedWatch Answer - FDA's medical safety reporting program for medical
professionals and consumers
MedWatch Safety Alerts Answer - The FDA publishes safety alerts for FDA-
regulated products: Rx and OTC medications, Biologics (aka blood), medical
devices, combination products (nasal spray), infant formulas, special nutrition
products, cosmetics, food
FDA 3500 Answer - Med Watch program reporting form for healthcare
professionals
FDA 3500b Answer - MedWatch program reporting form for consumers
The Center for Devices and Radiological Health (CDRH) Answer - The FDA
center responsible for for overseeing the medical device program. The FDA
monitors reports of adverse events and other problems with medical devices
and when needed, alerts patients, health care providers, industry, and the
public.
