Distribution of RWE Reprint
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Hi PAAB,
As per the new RWE Guidance document, presentation of results from RWE must be informational and claim neutral. This can be done when RWE is presented within a specific APS material but not sure how this requirement would apply if an RWE reprint would be distributed by Sales Reps.
If an RWE paper is consistent with the TMA and meets all other requirements in section 1 of the RWE guidance. Can Sales Reps proactively distribute the reprint given language within it will NOT be informational and claim neutral? Would the answer differ if it is distributed by Reps in non-promotional vs. promotional manner?
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Hi PAAB,
As per the new RWE Guidance document, presentation of results from RWE must be informational and claim neutral. This can be done when RWE is presented within a specific APS material but not sure how this requirement would apply if an RWE reprint would be distributed by Sales Reps.
If an RWE paper is consistent with the TMA and meets all other requirements in section 1 of the RWE guidance. Can Sales Reps proactively distribute the reprint given language within it will NOT be informational and claim neutral? Would the answer differ if it is distributed by Reps in non-promotional vs. promotional manner?
Hello @tk2022
The act of proactively distributing the reprint by reps is inherently promotional. While the activity of sales rep discussions do not fall under the PAAB Scope, distributing materials that have promotional intent, even in an unbranded form, falls in the realm of advertising and is thus subject to the provisions of the Food and Drugs Act. They must meet all the requirements of the PAAB Code, including Guidance Documents. Since the RWE Guidance is a relatively new Guidance, we strongly advise seeking a formal PAAB opinion for RWE studies to ensure compliance with the PAAB Code/Guidance document to help clarify the regulatory interpretation for the acceptability of these studies. It’s also important that sales reps are trained to understand the regulatory nuances surrounding RWE materials and to ensure they do not inadvertently promote non-compliant information. Limiting the distribution to materials that meet the regulatory requirements can mitigate risk. The primary goal here is to ensure that sales rep activities do not inadvertently cross into promotional material distribution that violates the Food and Drugs Act.
Given that RWE is still a relatively new area for regulatory guidance, creating a reprint holder for a RWE study would be a prudent approach to ensure regulatory compliance, particularly when it comes to promotion/distributing the study through sales reps. Pre-clearance review helps mitigate risks associated with the distribution of these materials.
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Hello @tk2022
The act of proactively distributing the reprint by reps is inherently promotional. While the activity of sales rep discussions do not fall under the PAAB Scope, distributing materials that have promotional intent, even in an unbranded form, falls in the realm of advertising and is thus subject to the provisions of the Food and Drugs Act. They must meet all the requirements of the PAAB Code, including Guidance Documents. Since the RWE Guidance is a relatively new Guidance, we strongly advise seeking a formal PAAB opinion for RWE studies to ensure compliance with the PAAB Code/Guidance document to help clarify the regulatory interpretation for the acceptability of these studies. It’s also important that sales reps are trained to understand the regulatory nuances surrounding RWE materials and to ensure they do not inadvertently promote non-compliant information. Limiting the distribution to materials that meet the regulatory requirements can mitigate risk. The primary goal here is to ensure that sales rep activities do not inadvertently cross into promotional material distribution that violates the Food and Drugs Act.
Given that RWE is still a relatively new area for regulatory guidance, creating a reprint holder for a RWE study would be a prudent approach to ensure regulatory compliance, particularly when it comes to promotion/distributing the study through sales reps. Pre-clearance review helps mitigate risks associated with the distribution of these materials.
@jennifer-carroll A clarifying question, may I ask what is meant by "creating a reprint holder for a RWE study?"
What copy would potentially appear on this "holder"? Would it be all requirements from Section 2 of the PAAB RWE guidance?Would the "reprint holder" be applicable to virtual distribution?
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@jennifer-carroll A clarifying question, may I ask what is meant by "creating a reprint holder for a RWE study?"
What copy would potentially appear on this "holder"? Would it be all requirements from Section 2 of the PAAB RWE guidance?Would the "reprint holder" be applicable to virtual distribution?
Hi @tk2022
Reprint holders are a common term we see in advertising for the “folder” which houses the reprint. This can be as simple as the brand name, study title, and fair balance, or house complex claim copy. The content that appears is at the discretion of the sponsor as long as it meets the advertising requirements. All requirements from Section 2 of the PAAB RWE Guidance would apply. Yes, it is applicable to virtual distributions. An unaccompanied (by any form of verbal or written information designed by or on behalf of the manufacturer for the purpose of promoting a health product) study reprint pdf in its original form (i.e. unaltered) is exempt from PAAB preclearance but not advertising regulations, however if additional verbal/written messages or context is added through the distribution channel, it may not be exempt as noted in our previous response. We suggest submitting for an opinion if you are unsure.
