The more common pathway, PMTA is designed to provide FDA with the means to issue marketing orders for NGPs that are “Appropriate for the Protection of the Public Health (APPH).” MRTP differs in that the bar is set much higher such that the marketing authorization granted by FDA is “Appropriate for the Benefit of the Public Health (ABPH).” There are two subtypes of MRTP marketing authorization that FDA can award, the first is “modified exposure” and the second is “modified risk.”
Modified exposure indicates that FDA have confidence that use of the NGP will result in a reduced exposure to harmful chemicals compared to smoking combustible cigarettes. Modified risk, indicates that FDA is confident that the health risks associated with use of the NGP are reduced compared to smoking combustible cigarettes. To date, there are only two brands that have gained an MRTP marketing order, eight snus sub-brands have received a modified risk marketing order and one heated tobacco product with two sub-brands of heat sticks have received a modified exposure marketing order.
In many ways, an MRTP can be viewed as an upgrade to the PMTA authorization, with all of the PMTA data serving as a basis to build on for an MRTP.
All MRTP applications are subjected to a review by and a presentation to the Tobacco Product Scientific Advisory Committee (TPSAC). This is a task that should not be underestimated. A TPSAC hearing provides you with an incredible opportunity to present your product and demonstrate to TPSAC the confidence in your submission package. The onus is on you to convince TPSAC why the data you have generated will be ABPH. At Broughton, we have consultants experienced in dealing with FDA and in preparing for a TPSAC hearing. If required, we will be a part of the team defending your position to TPSAC. Through a series of workshops, we ensure that you are ready to defend your application in the most convincing way. You can be assured that you have one of the most experienced teams by your side.
Another important element of the TPSAC process is that your dossier will be published for public comment. It is important that any proprietary information is effectively redacted. As part of our service, we work with your legal team to ensure that the appropriate parts of the dossier are redacted, removing confidential information whilst maintaining a convincing narrative to be commented on.
The Broughton team have been involved in previous MRTP applications and have a deep understanding of how PMTA datasets are supplemented to ensure that sufficient data for an MRTP is collated.
Our team of scientific consultants have years of experience in their fields allowing us to create bespoke scientific strategies. They will recommend the ideal study designs to generate the data to prove hypotheses that will provide FDA with confidence that your product can be deemed reduced exposure and / or reduced risk.
Whether you are looking to put a completely new NGP on the market under the MRTP pathway or you already have a PMTA and want to understand the fastest and most efficient route to use that information to file for an MRTP, Broughton have the experience and deep-industry knowledge to support you on this remarkable journey.
From basic questions to complex compliance inquiries, we're here to help! Contact us today.