As the September 9th, 2020 PMTA deadline rapidly approaches, our Chief Scientific Officer, Chris Allen, takes a look at the current US market situation and what companies can expect moving forward.
What is FDA saying?
As expected, FDA has received thousands of applications, with many of these being within the past two weeks. By FDA’s own admission, they may not have the resources to perform a complete review of all applications within the deadline. As stated by Mitch Zeller, “Depending on the number of new applications we receive by the deadline—which could be anywhere from a few hundreds of thousands to millions—as a matter of practicality we may not be able to fully complete review of all tobacco product applications that we receive by September 9th, 2020 within a year”.
Although companies have been bound by the law to submit their PMTAs by September 9th, 2020, in a similar manner, FDA themselves should be bound by law to adhere to the one-year substantive review period. In these instances, one can only expect that if the review hasn’t been concluded that some form of enforcement discretion will be applied. Or could there be an extension of the substantive review period? FDA is also stating that the processing time of applications has been slowed down due to receiving more paper submissions than expected and many electronic submissions lacking text recognition, thus making it harder for staff to search the submissions for specific information.
Is COVID-19 still a factor?
Many companies continue to be impacted by the ongoing global pandemic, which may in some cases result in incomplete submissions. Following recent communications from FDA, it has been made clear that there will be no extension to the PMTA deadline. However, providing an application is made on time and meets the statutory and regulatory requirements under sections 905 and 910 of the Federal Food, Drug and Cosmetics Act, in order to be accepted and proceed to scientific review, FDA will take individual circumstances into consideration. If it is clearly stated what data is missing and why COVID-19, a recent natural disaster or other unforeseen circumstances has affected the ability to provide this information, then it may be possible to provide the additional information during the review period.
FDA review timelines
Many are asking, how quickly will we receive our notification of acceptance to file and review? The answer is it depends. At Broughton we observed with early submissions, that this was extremely quick and PMTAs were moving into substantive review within three weeks or less. As the deadline has approached, this period has become significantly longer, most likely related to the increase in number of applications being made. However, it is noted that JUUL made their application relatively late but were quick to announce that it had entered into substantive review. Does this indicate that FDA had staff on-hand and ready for the JUUL submission? As stated by FDA “This means providing adequate review resources for reviewing those products currently on the market that have the greatest chance, either positively or negatively, of impacting public health”. Regardless of your standpoint on JUUL, with the market share they command, there’s undoubtedly a significant impact on public health regardless of which side of the fence you sit.
Assuming that your application has been accepted for filing and review, then what are the next steps? Although companies are expected to provide high quality submissions, it is considered likely that most companies will receive a deficiency letter with a 90-day deadline for companies to respond. Although 90 days may sound like a long time, depending on the nature of the deficiency and the work required to address, the clock is most definitely ticking. Throughout the review process, we encourage companies to ensure that all their providers are on-hand to respond as soon as possible in order to avoid any delays. Deficiencies often require additional regulatory scientific studies to be performed, so a rapid response from your providers is of paramount importance. Our advice is to consider what contracts can be put in place to ensure that your Contract Research Organisation (CRO) can provide the resource as soon as it’s needed. Your providers themselves may face inspection by the FDA which is an important factor to take into consideration.
Companies should also ensure that they have samples ready to dispatch to FDA when requested. A deadline of 14-days will be applied once the request for samples has been made.
What next in the short term?
What will change on September 10th, 2020? Perhaps not a lot will change immediately and it’s unclear where FDA will focus its enforcement activities. FDA has stated that they will look to make publicly available a list of the new tobacco products that have submitted a PMTA aligned with the September 9th, 2020 deadline. However, with the legal processes involved, there’s no indication how long this will take. It, therefore, seems unlikely that small retailers will be faced with enforcement action, when it is difficult to determine which products have/have not been submitted within the deadline. It’s more likely that FDA will continue targeting products they deem to have the most negative impact on public health, in particular those products seen to be associated with youth uptake. This may involve targeting online sales and also checks on imports from overseas countries.
What next for the future?
In three words; innovation, innovation, innovation
Undoubtedly, this is a period of turbulence and change for the ENDS industry. The way that the regulatory pathway in the US has been designed has meant that manufacturers have prioritised investment into their current products on the market. However, following the September 9th, 2020 milestone for this unique industry, a paradigm shift to innovate and create safer products will surely carve the future for this exciting market. Rapid scientific and regulatory learning will help to streamline the application process and accelerate next generation products to market.
Whether you’re already in this industry or looking to capitalize on the market disruption by entering with a new product, you should certainly consider working with a Contract Research Organization (CRO) that has had significant involvement in the PMTA process. Broughton draws on deep industry experience and a global team of experts to guide companies through their PMTA projects, including early-phase product development to accelerate your innovation to market.
Finally, as stated in Our Team Commitment, everything we do must be of high quality. This is our first responsibility to our clients around the world who use and trust our services. Every employee of our Company proudly accepts this responsibility every day and we are delighted to receive feedback from clients along the way like these below:
“You guys made some big promises 12+ months ago, and you ultimately exceeded expectations. Again, I thank you for your commitment, and I look forward to continuing to work with you over the coming months/years.”
“It was great pleasure working with you and appreciate sharing your knowledge, wisdom and guidance. Achieving milestones was not possible without you and your team. You have an excellent team. Each one of them went above and beyond to help us.”
Broughton have deep CRO capabilities and an experienced team of scientific and regulatory professionals to manage full service global regulatory projects including PMTA. Our knowledge of global regulatory pathways offers significant insights that can be incorporated into your New Product Development plans. Our mission is to accelerate safer nicotine-delivery products to market; advancing a smoke-free future.
Book a meeting with us today to discuss your requirements.