William,
I have tried a couple times in the recent and distant past to combine an Rx and OTC product into one Instructions for Use (IFU) with no success. The reviewer wanted to see separate IFUs because of indications for use (often these were slightly different), clarity on who is the actual user, and one even cited usability issues as related to IFU since the Rx one had a lot less information that was not sufficient for OTC. Just as Victor said, it is quite difficult to write one IFU that covers both though this really does depend on the product. You can keep trying as there might be a reviewer that would accept, but I have not had any luck.
While the REGEX community is moderated, the moderators are not doing this from a technical perspective. In fact, I had one person citing in their documents for regulatory updates Elsmar Cove as a source of information, I strongly advised them to remove that as a source of information. While some people have "inside tracks" to regulatory developments they share with the group here, there is no verification or validation of these sources. Plus as you can imagine, there are lots of regulatory interpretations and even things I post try to say things like 'in my opinion' or 'in my experience' because it does not necessarily mean it is correct or the absolutely way it can be done. Now with that said, I think you could cite this a general "forum" where information can be obtained. As an example, in the procedure I developed for keeping up to date on regulatory information, there are lots of different sources cited such as regulatory websites, industry trade websites, consulting companies websites, white papers, and other forums (which I do include this in).
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 02-Jan-2019 16:49
From: Victor Mencarelli
Subject: RX & OTC Package Insert
Hi William.
My gut says that a combined PI is going to be a difficult sell to FDA for a very simple specific reason - the PI would need to provide "adequate directions for use" for both the OTC and the RX uses. Since the RX uses, by definition, cannot have adequate directions for use written for a lay person to understand, it is in my opinion almost impossible to write a truly combined PI for a product that can be both OTC and RX. Additionally, the RX uses by definition require the order of a licensed healthcare provider to dispense the item which obviously is not the case for the OTC uses. Therefore you would be essentially providing the RX information in my mind almost as an off-label use of the product to the end user in this case.
As for use of REGEX as a consensus of the industry, that might be a bit of a stretch. I think you can use some of the information provided by individuals on the forum as support for any of your justifications but I think that just because the majority of responses "agree" or "disagree" with a particular position is almost impossible to correlate to the industry since (1) not all members of industry are on REGEX; (2) even some who are on REGEX might not be allowed by corporate policy to respond to posts; and (3) even when there are disagreeing members of the community, they might be hesitant to disagree especially with a position that many have taken even though the disagreement is substantial and maybe based on the person's own specific experience.
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Victor Mencarelli
Director Regulatory Affairs
United States
Original Message:
Sent: 02-Jan-2019 14:27
From: William Coulston
Subject: RX & OTC Package Insert
REGEX Community,
I was hoping to get your advice on the acceptability of combining RX and OTC information into one package insert. On a previous 510(k) I submitted a combined package insert and label that included both RX and OTC IFUs, but my reviewer had me break them out separately. I cannot tell if that was a review-ism or a "rule". I have seen combined package inserts before on other products. Any guidance is appreciated.
On a separate topic, what are your thoughts on using responses from REGEX as a sort of consensus on standard practices within our industry, particularly when used as justification as part of risk management?
Thank you in advance for your time and consideration.
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William Coulston
Quality & Regulatory Affairs
San Antonio TX
United States
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