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3 min reading time
Life science companies have paid multi-billion-dollar fines resulting from non-compliant promotion. FDA requires companies to have a system in place to ensure that their promotions meet FDA expectations.
Big device companies have an internal Promotional Review Committee (PRC) or a Medical Legal Review (MLR) Committee to review external-facing pieces. MLRs typically have three core members:
• Medical: They typically work in the Medical Affairs department and often have doctorates in Pharmacy, Medicine, or a PhD in the life sciences. They review for FDA and Federal Trade Commission (FTC) compliance.
• Legal: They typically work in the legal or compliance departments and often are attorneys with a Juris Doctor degree. They evaluate if the piece violate laws including HIPAA, the False Claims Act, Anti-kickback law, preexisting agreements, etc.
• Regulatory: These individuals are often well-versed in FDA requirements and review claims in the context of FDA expectations.
So that’s for the big firms. What are the rest of you – who can’t afford full-time medical and legal teams – doing for MLR reviews?
I learned you can outsource the entire MLR function. http://medgroup.biz/outsource-MLR is one place that does it, you may know of others.
In Kulkarni’s case, he has medical, legal, and regulatory groups to help in concept review and campaign development.
How are you reviewing your promotional pieces?
Do you “know what’s impermissible” when you see it and are comfortable approving pieces on that basis?
Share your thoughts in today’s comments for the group.
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Make it a great week.
P.S. Forward this announcement to folks in your network who would value it.
G M Butcher
Shireen Du Preez
Meher N Sahai
G M Butcher
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