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.

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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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Discussions

Technology Replacing QARA Professionals

Country of Origin Requirements

Easier to obtain CE Mark approval than FDA clearance?

Draft proposal of the new MDD

TGA’s stricter requirements for Medical Device dossiers
http://bit.ly/so-strict

Inexplicable Open Payments data released by CMS

Impact of Brexit on CE Marking?

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Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. Forward this announcement to folks in your network who would value it.

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G M Butcher
CEO Emeritus, IRQS
@David, yes and I agreed above. In addition to your comments – I have seen many start-ups with (external) medical and legal reviewers that required an explanation of ‘what to do’. Legal reviewers were particularly egregious.

David Field
President / CEO at Southern Spine, LLC
This a very good discussion. Obviously the larger companies have teams and departments and procedures to handle these promotional reviews. In the smaller start ups, these reviews are typically addressed by a couple of key members of the management team. We usually review internally and if we have a significant concern, we send it out to our consultants in Medical, Legal and/or Regulatory review based on the need.

Stacy Livingston
Senior Consultant Obelis USA Branch, A leading provider of EU Compliance Solutions to companies worldwide for 30+ Years
As far as the EU is concerned, review of the promotional materials is something that should be covered under the services of any professional Authorized Representative. At least that is the case under our services towards brand owners.

Shireen Du Preez
Marketing Consultant. Looking for Permanent Position
Each country has a regulatory body either within the industry or government regulated. Investigate and do your research. Marketing and presenting your product should get the same time and investment the development did.

Joe McMenamin
Medically trained health lawyer; telehealth advisor; public speaker
Along similar lines, consider a review of your web site for compliance and risk management purposes.

Cindy Suchy
Pharmaceutical professional with drug/device pre and post market expertise. *Open to new opportunities
Independent medical review consultant who can help you with your promotional review needs.

Christine Zomorodian
Principal Consultant at Gish Consulting
The changes in EU regulation along with the ISO 13485 transition should spark many internal review projects at every single medical device manufacturer that has CE-marked products.

Christine Zomorodian
Principal Consultant at Gish Consulting
At the moment, piecemeal, as each product comes under discussion.
I am urging a holistic effort to review all labeling claims for each product, selecting those that need to change. It’s likely that some marketing dept training needs will emerge; perhaps a new work instruction. Also, a clarified set of requirements for regulatory affairs to perform reviews.

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
How are you approaching it, Christine?

Christine Zomorodian
Principal Consultant at Gish Consulting
Dealing with this issue now for a client.

Meher N Sahai
Serving with Orthopedic Product is our speciality
Joe this is new way of looking at . Good iinformation.

Sheila Doyle
Managing Director
Joe Advamed has some good courses that cover the basics we also use our legal and regulatory consultants. The Advamed courses feature fda, ftc, and lawyers speaking.

Livia Cabrera
Quality and RC Manager, Puerto Rico and South Latin America at Abbott
Would like to share this post but can’t find the way. Help please! 🙂

G M Butcher
CEO Emeritus, IRQS
This is good info that has not yet reached the level of common understanding, I think.

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Livia, the direct link for this discussion is https://www.linkedin.com/groups/78665/78665-6158580286297829377