Medical Affairs
Work in promotional review, evidence planning and scientific communication.
Teaching the medical reviewer's lens using real FDA-regulated advertising
Author and presenter, under mentorship of Dr. Lizandra Marcondes
The problem
Doctors moving into industry tend to read a drug advertisement as marketing. It is a regulated document that a medical reviewer signed off on before it aired. Not seeing that difference is where a new medical affairs hire creates compliance risk, and reading the regulations on their own does not fix it.
What she did
Designed and taught a class that works the way a reviewer works. It starts with the five elements the FDA requires in a consumer product-claim advertisement, then sorts advertising into product-claim, reminder and help-seeking, because each type carries different obligations. A reminder ad, for instance, is unavailable to any drug with a boxed warning.
The material
Participants review four real US campaigns and their brand websites, each chosen to raise a different problem: where safety information sits when a website has unlimited space, how a brand handles the indications a single television spot cannot carry, testimonials and copay cards as regulated content, and HCP gating in oncology. The drugs span a boxed warning, two biologics with serious infection risk, and a checkpoint inhibitor with immune-related events across every organ system.
What participants leave with
The class closes on the MLR committee, mapping what the medical, legal and regulatory reviewers each own, so participants know which seat they would occupy and what the person beside them is accountable for. The organizing argument is that fair balance is the requirement most often technically satisfied and least often actually satisfied.
Result
Delivered to a mentored cohort of seven physicians. One went on to secure an MSL position, and others now apply the framework directly in their own work as company speakers, where the same promotional rules govern what they can and cannot say from the podium.
What this means for a medical affairs team
Promotional review is the part of the role clinicians entering industry are least prepared for. This is documented work inside that framework, at the level of specific FDA requirements and specific commercial content.