Advice for helping clients understand what is FDA guidance and what is discretionary to MLR? Client is new to branded pharma and a little lost but is looking to us for help.

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I recommend bringing receipts, ie, actual FDA language, and link to the site.

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You’re likely not going to win too many battles with their MLR team when it comes to their interpretation of the Agency’s guidelines. What you can do is push back when they’re inconsistent, because that’s what costs your client money unnecessarily.

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I do this all the time, the client understands fine, and it honestly still gets me nowhere.

Neither we nor our clients have the clout to tell regulatory reviewers to piss off. Even when they're wrong.

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Three points —
1. The FDA regulations themselves (21 CFR) are remarkably broad, leaving specifics (e.g., how and where fair balance must be displayed) to administrative enforcement and issuance of "Guidance" documents.
2. FDA enforcement vacillates in strictness — from activism, like that of Commissioner David Kessler in the 90s, to lower-key, like that of recent administrations, to the current pendulum swing back to greater strictness. Moreover, Guidance documents are explicitly non-binding and can be (and often are) revised or overridden by subsequent administrations.
3. Given the intrinsic uncertainty of FDA response, MLR in virtually all pharma companies takes a more conservative and risk-averse stance than FDA. So the key to understanding where the guardrails are varies from client to client...and even from brand to brand, depending on the makeup of the MLR review committee assigned to that brand. Advise your client to get to know his specific committee.

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