With 2018 coming to a close, we’re taking some time to reflect on how the industry has evolved this year, what we’ve learned, and how it might influence our future. Over the last year, the FDA issued 7 OPDP letters, took steps towards advancing medical device development, and approved a record number of novel drugs. At Vodori, 2018 was filled with exciting advancements in both the Pepper Cloud product suite and Vodori Interactive services.
In case you missed it, here’s our roundup of the biggest trends, lessons learned, and successes of 2018 and what to expect as we turn the corner into 2019.
Top Industry Trends of 2018
Another year of low OPDP letters: is this the new normal?
In 2017, we hit a record low in the number of warning and untitled letters issued by the FDA’s Office of Prescription Drug Promotion (OPDP). 2018 was no different, with 7 total (5 untitled and 2 warning letters), marking only the third year in which the OPDP has issues less than 10 letters.
Many have speculated as to why. Was there a shift in the FDA’s priorities? Were MLR teams more careful in their review process? Or as a recent BioPharma Dive article indicated, is the FDA more focused on “drafting guidance documents, taking resources away from finding companies that could be worthy of sending letters to?”
Regardless, we’re left wondering what we should expect from the FDA in 2019. The BioPharma Dive article goes on to quote Julie Tibbets, a partner at the law firm Goodwin, who says “[there] could be a risk that companies alter their risk appetite in the promotional space and recalibrate based on what would appear [to be] a really rare chance they may be on the receiving end of one of these letters.”
While a possible scenario, we believe it’s more likely that companies continue to maintain the status quo in 2019; after all, nobody wants to be the focus of one of these letters. It’s also worth noting that while letters may be down, that does not necessarily mean life science companies have been free from liability. There have been several FCC and State Attorneys General sanctions over the last several years, totaling over $3 billion in fines since 2013.
Focus on advancing medical device development
The FDA has been placed under substantial scrutiny lately for their 510(k) clearance process, which allows for a product’s approval if a “substantially equivalent” product (a “predicate”) already exists on the market. These fast-tracked approvals based on predicates represent the majority of medical device approvals in the US (82% of all devices cleared or approved in 2017), and there was previously no restriction on how old the predicate could be.
Well that is about to change. In November, FDA Commissioner Scott Gottlieb put out a statement highlighting the FDA’s actions to modernize their approval process with one end goal: “ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.” The proposed actions include, among other things, looking at ways to promote predicates that are less than 10 years old. “We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria,” said Gottlieb in his statement.
As the FDA places more scrutiny on their medical device approval process, we can only wonder what this might mean for possible changes to the FDA’s review of medical device advertising and promotional materials.
Stronger emphasis on privacy and data security
The past few years have been riddled with data breaches (e.g. Equifax, Google) and gross mishandlings of user data (e.g. Facebook), placing personal privacy under a more powerful microscope than before. Fearing that they too could be vulnerable, many companies have doubled down on their internal data security and placed added scrutiny on their vendors’ data security requirements.
While not a direct response to these breaches, the EU also put the wheels in motion for stricter protection of their residents and citizens’ personal information. The General Data Protection Regulation (GDPR) updates became enforceable in May 2018 and required organizations to make significant changes in the way that they collect, track, and use customer data. While HIPAA makes the US healthcare industry no stranger to data privacy, GDPR requirements put added scrutiny and restrictions in place to protect more personal data in the EU and across the globe.
Groundbreaking new therapies
The FDA has once again set a record high in novel drug approvals this year, approving a total of 55 so far. That number is a 20% increase over 2017 and a staggering 150% increase over the 22 novel drugs approved in 2016.
Some of the most notable approvals this year include:
- Gilead’s Biktarvy for treatment of HIV-1, which is expected to reach blockbuster status sometime next year
- Bayer & Loxo Oncology’s Vitraki, one of the first of its kind to target a cancer’s genetic mutation rather than a specific type of tumor
- Genentech’s XOFLUZA, a one-dose treatment for the flu
We look forward to seeing what innovations next year will bring. If 2018 was any foreshadowing of what’s to come, 2019 could be another record setting year.
This year also marked a number of big wins for Vodori and Pepper Flow, including:
- A 65% increase in Pepper Flow users, some coming from paper-based processes, and some migrating from quality systems and other promotional review systems
- Planning, concepting, and executing more than 60 strategic projects for Vodori Interactive customers
- Doubling down on our unlimited end-user support by responding to over 2,500 questions and support requests with an average response time of less than 30 minutes
- Quarterly releases delivering over 30 new features and customer-requested enhancements to Pepper Flow
- The release of Pepper Flow’s smart reference linking feature, which enables Pepper Flow to automatically search for and suggest references based on previous usage in the application (video here)
- The announcement of the Pepper Flow Acceleration Program, providing significant favorability to pre-commercial companies
- The election of Vodori’s new Board of Directors
So What’s Coming in 2019?
While we can’t predict what the industry will bring in 2019, we can tell you what we’ll be up to next year.
Continuing our vision of customer-driven innovation
We have always been hyper-focused on delivering customer-centric features that help to make our end users’ jobs easier while maintaining simplicity. To that end, our 2019 product roadmap includes significant enhancements to the way our users work.
Most notably, we’re introducing a substantial change to the web review process. Today, organizations create static PDFs for their digital web properties and annotating directly on those PDFs. We believe there’s a better way; we want to reduce the preparation effort on submitters and demonstrate actual web page functionality for reviewers. That’s why we’re prototyping more interactive options, interviewing customers and prospective customers, and planning for an industry first — the ability to annotate directly on live web pages.
Interested in sharing your opinion and shaping the functionality of this feature? Join our market research panel at research.vodori.com.
Attending new conferences
We love engaging with current and prospective customers at a variety of conferences across the country. We learn so much about challenges you and your teams are facing, lessons learned, and what to expect in guideline updates.
This year we’re broadening our horizons and planning to attend several new-to-us conferences and congress events; we hope that we’re able to meet more of you, hear about your challenges, and most importantly learn from you. We’re still shoring up our 2019 conference plans and can’t wait to share the list with you. If there’s a conference you love, drop us a line at firstname.lastname@example.org to let us know!
Introducing our agency capabilities to more customers
Vodori Interactive, the marketing agency arm of our company, is the best kept secret among our current customers. Over the last 13 years, we have brought hundreds of projects to life, both big and small, from website redesigns to customer journey mapping to complex system integrations. We’re excited to introduce our agency capabilities to more and more customers in 2019.
The perspective that we learn on the interactive agency side also fuels our passion to improve Pepper Flow. As we launch websites, build sales aids and leave behinds, and create online portals and apps for our customers, we learn what you and your agencies need to be successful in routing that content for review. That’s why we created Pepper Flow. For you, and for us.
Reflecting on 2018 makes us all the more excited to see what 2019 will bring. We look forward to working with more of you next year and seeing how your innovations shape the future of healthcare.