Further FDA delays to NSURE guidance on Rx-to-OTC switch

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One of the key topics at our North American OTC Conference to be held in Morristown, New Jersey this week (20-21 June) is Rx-to-OTC switch, and opportunities for marketers in the dynamic US regulatory climate. Hopes that the FDA would publish guidance this year on the Nonprescription Safe Use Regulatory Expansion (NSURE) were recently dashed after the Notice of Proposed Rulemaking date was changed to February 2019.

NSURE was introduced in 2012 to encourage utilisation of technology to “ensure” the safe use and self-selection of innovative Rx-to-OTC switches, but the programme has been stalled for several years.

At the Consumer Healthcare Product Association’s recent Regulatory, Science & Quality meeting, FDA Deputy Director for Regulatory Programs, Dr Doug Throckmorton, assured attendees that the 5-year delay had “nothing to do with our interest and support”, but was a result of administrative priorities. He encouraged sponsors to bring ideas to the FDA. This request has been voiced for several years, but manufacturers appear to be waiting for the draft guidance.

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For those that can’t make this week’s meeting, Nicholas Hall’s Opening Address will be live-streamed here at 8.30-9.10 on Wednesday 20 June.

Following this, you can also view these live presentations:

Dave Wendland, Hamacher Resource Group, will be presenting on Independent Pharmacy Opportunity: Myth or Reality? on Wednesday 20 June 09:40-10:10 here 

Join the CHC Institute Launch with Steve Sowerby and Ed Rowland on Wednesday 20 June 14:15-15:15 here 

See Joseph McGovern, Everything Health, review the Key Issues of Switch on Thursday 21 June 09:00-09:30 here 

Plus, join Everything Health’s Mary Alice Lawless & Joseph McGovern to review how you can Change the Words to Change the World in the move from OTC to Non-Prescription, followed by Nicholas Hall’s Summary & Close of the meeting on Thursday 21 June 12:40-13:30 here 

All timings EST. To ensure you enjoy the event in full (download the brochure here), including panel sessions and networking opportunities, reserve your place now by contacting lianne.hill@NicholasHall.com

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Barcelona Conference Report

In this week’s blog, we report back from Nicholas Hall’s OTC INSIGHT 29th Conference & OTC Training Academy Workshop in Barcelona, the first to ever see Nicholas Hall’s keynote address livestreamed to an audience across the globe via YouTube.

Nicholas’ opening address to delegates explored the 4 elements of PACE, which all marketers need to adopt in order to increase their pace and move faster:

P = Pharmacy and retail, the bedrock of the OTC market = 80% of revenue outside US (70% if inc US)

A = Adjacency, reaching beyond the 6 core categories of OTC and seeing where we can branch out (i.e. diabetes, Alzheimer’s, hearing screeners, etc)

C = Consumer (Nicholas was joined on stage by Luca Pagano of BeMyEye who explored how social changes have impacted how and when people buy, and the power of crowdsourced insights to transform in-store execution)

E = Engaging with the consumer and e-commerce (as Nicholas said, the topic of e-commerce would be deserving of a whole conference of its own)

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Nicholas Hall encourages OTC marketers to pick up the PACE

On Day 2, another packed schedule of speakers was rounded off with David Blair, Google’s Head of Industry Heath. His presentation to delegates explored three major trends which are impacting everything we do: chip, cloud computing and AI / machine learning.

Today we practically live online, and the smartphone is now the consumer’s main device – through which nearly all traffic passes – a fact that is having a massive impact on the health industry. Blair said that voice search is going to become the next key driver and could have implications for healthcare marketing (see our recent blog on this topic), as we move from Point of Care, where we expect the consumer to wait for appointments, visit the doctor and then the pharmacist, to a space where we can have care anywhere.

In 2017, there were 160bn searches for healthcare globally via Google, with 2bn alone just for the allergy category! Almost two-thirds of these searches were conducted via a mobile device. There was also an increase for searches for “best non-drowsy allergy medicine”, “best cold & flu medicine” and so forth. Last year, Google also saw a 60x increase in searches for “near me”, highlighting the shift towards immediacy.

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Google’s David Blair closes out proceedings

For more updates on consumer healthcare trends, and a full round-up of Day 1 and Day 2 proceedings, be sure to follow Nicholas Hall on Linkedin

NHC North America Conference: Day 2

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Here’s the second and final blog review of our recent regional North American OTC Conference, which took place last week at The Westin Governor Morris hotel in Morristown, New Jersey.

Our first speaker on Day 2, Bernie Simone, Head of Rx-to-OTC Switches NA, Sanofi, discussed the growth engine for consumer healthcare and improved consumer self-care relating to Rx-to-OTC Switch, and highlighted how 43% of OTC industry sales are associated with a Switch, with almost half of proposed Switches failing. Bernie also explained the concern that Switch will no longer be possible if the medical community does not approve, and so it is imperative that we as an industry think of new initiatives to involve communities in the earlier stages of the Switch process in order to identify viable and novel Switch candidates.

Following Bernie on stage was Chuck Jolly from Baker Donelsen, who reviewed legal risk amelioration strategies that can be adopted by marketers to safeguard their practices, leading us into our first networking hour of the day.

Vidhu Dev, VP, Rx-to-OTC Switch & R&D, GSK, then gave us an informative outlook on Switch overseas and the likely future challenges and successes, before focusing back on the local US market – for example, the US OTC allergy market has continued Switch activity, is highly competitive and dominant. Vidhu also identified possible categories for OTC switch candidates, such as antifungals, anti-diabetics and cough & cold, and the evolving role of the pharmacist will be integral in making this possible.

Our panel then took to the stage, debating the establishment of collaborative relationships with payer, retail and CPG entities to put the consumer first and deliver superior outcomes.

Shannon Huneke of UHC, Colleen Lindholz of Kroger & Chris Jobes of J&J came together to discuss their collaboration in the healthcare ecosystem. Together they discussed their marriage of information on consumer insight and their segmentation of this, and how this equips them in the battle against industry challenges, and transforms the behavioural science behind consumer healthcare. The panel also mapped the patient’s journey through their condition, with each journey presenting an opportunity to translate individual patient requirements. They concluded by asserting that we can’t get where we want to be in healthcare without partnerships – and if we can create a healthier population, we all win!

Our unplugged panel session continued as Christina Speck, Head of Brand Partnerships & Sponsorships, Aetna, and Brian Doherty, Executive VP, Managing Director, Ogilvy CommonHealth, joined forces to discuss partnerships, technology and engaging healthcare consumers in the real world. Together Christina and Brian discussed consumers living in a digital age, with Christina mainly focusing on Aetna’s partnership with Apple products and apps. Christina highlighted how healthcare and well-care are not exactly fun (but they should be!), which is where the combination of technology creates a vision for this, connecting clinical and well-care, and demystifying healthcare communications.

Our panel discussions certainly gave some food for thought in time for lunch, with many delegates taking the time to discuss and debate the key learnings with industry peers. Returning from lunch, we saw Walmart executives Alex Hurd, Senior Director of Health & Wellness Transformation, and Jamie Grace, Senior Director & Merchandise Manager, explore the role of retail in providing access to high quality care at lower costs.

John Delfs from The Foundation for Health Smart Consumers shared with the audience the need to empower consumers through motivation and collaboration with HCPs, and was followed by Randy Vogenberg from the National Institute of Collaborative Healthcare, who gave us an insight into access trends for OTCs, delving into innovation, incubation and implementation.

Mary Alice Lawless, from our conference partners, EverythingHEALTH, then took to the stage to identify and analyse new strategies for unlocking the next generation of Rx-to-OTC Switch, before an esteemed panel of moderators debated the next steps in consumer healthcare transformation. Panellists included Joseph McGovern of EverythingHEALTH, Andrea Leondard-Segal, former FDA Director of the Division of Nonprescription Clinical Evaluation, Helmut Albrecht, President of H2A-Associates, and Dennis Tze, Biograph Inc. Together they asked whether we should provide case studies for the Switch industry, questioning how we can enhance changes in Switch through branding and digital.

Overall our first North American conference was a real success, with a fantastic turn out, excellent insights, a riveting display of speakers and plenty of industry knowledge. We certainly hope to see you next year and thank you all for joining us in this first time North American conference experience!

#NHOTC17: Day 2

OTCINACTION

This week we publish our second and final blog update on our 28th European OTC INSIGHT conference, which took place in Munich earlier this month and was centred on the theme of Making the Most of New Technology. Below is a quick round-up of proceedings on Day 2.

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Ed Rowland opens Day 2 proceedings

Ed Rowland opened the conference with an update on key drivers and dynamics in the US OTC strategic landscape. Akhil Chandra of Reckitt Benckiser led us into our final networking hour with a discussion on what makes an iconic brand in a world of biosimilar products. Chandra based his talk around the “iconicity” of Nurofen, insisting that when it comes to brands we should challenge the tendency to default, and instead create, identify and nurture iconic / symbolic elements.

Following an hour of networking with OTC peers, our delegates returned for our final session with Jesus Carrasco, Head of Healthcare at Société Générale, who discussed consolidation and the increasing attractiveness of the consumer healthcare industry from a corporate and investor perspective.

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Thornsten Umland from Bayer gave the final presentation on strategic growth and how to build OTC businesses and brands via well executed acquisition and true product innovation.

And finally, a personal message from Nicholas: “Thank you all for making a brilliantly successful conference, the array of speakers and topics covered have certainly left us all with food for thought on the OTC landscape in a world of digital!

As an official announcement, now the conference has ended, we hope to see you next year in… BARCELONA for our 29th European OTC conference #NHOTC18. Auf Wiedersehen or should I say… Adios!”

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Kraków Conference Debrief

I hope you’ve now had a chance to explore our full-year 2015 OTC Market Stats update, which includes up-to-date OTC trends and sales data at global, regional and country level (with the addition of Algeria and Morocco this year). I’ll be covering the key results as usual in the next tutorial blog, but for now, here’s your exclusive round-up from Nicholas Hall & Company’s latest event – Regards, Owen Hartnett.

Another successful conference

Nicholas Hall’s OTC INSIGHT 27th European Conference & Action Workshop was held in the beautiful Polish city of Kraków. Representatives from some of the world’s leading companies detailed their strategies to build sustainable OTC brands while delivering real benefits to the consumer, with all in agreement that the consumer must be at the heart of the brand for it to succeed (this year’s theme was indeed “Building Blocks for a Successful OTC Brand”). It was a great pleasure to meet people so passionate about our industry during the Networking Hours and coffee breaks in which I was conducting live OTC DASHBOARD demo sessions.

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An OTC DASHBOARD segment will feature in the upcoming conference video

One standout topic for me was the need for the consumer healthcare industry to engage with digital by choice, not necessity. Nick Melnyk, Managing Director of Central & Eastern Europe at Sanofi, warned that we could end up working for tech giants in future if we aren’t better equipped and more willing to turn to a digital strategy, noting that it is not the most adaptable who survive, but those who disrupt. Our ever-growing OTC DASHBOARD client base suggests a lot of you are already utilising healthcare data in this way, but we are still a long way off in terms of digital, especially in comparison to industries such as media, telecom and FMCG.

Thursday evening saw the return of the prestigious OTC Marketing Awards Ceremony, sponsored by Medical Brands. With so many talented marketers in the room, picking a winner for each award was far from easy, but the recipients below are certainly worthy winners in their respective categories.

Flonase_asset2Most Innovative Global OTC Marketing Campaign 2016

GSK’s early-2015 launch of Flonase Allergy Relief (following Rx-to-OTC switch approval) has garnered over US$300mn in sales, while remembering to put the consumer at the very heart of its brand proposition. Nick Srikanth, Chief of Staff, Europe Americas Region, graciously collected the award.

Screen Shot 2016-04-29 at 11.13.44The 2016 Colin Borg Award for the Best European OTC Advertising

Focusing on the special connection between father and son, P&G’s #HugYourDad campaign for Wick VapoRub Germany is a great example of a brand connecting emotionally with its consumers. Anna Sacha, Global Head, Consumer & Market Insights, was on hand to claim the top prize.

Screen Shot 2016-04-29 at 11.35.40Most Innovative New Product of the Year 2016

RB’s Strepsils Flurbiprofen Spray (Dobendan / Benactivdol Gola in other markets) wins this year’s Most Innovative accolade as it is the first OTC flurbiprofen product of its kind in a convenient spray format. A delighted Akhil Chandra, Global Category Director Analgesics, received the award.

Nicholas Hall concluded that people must be at the heart of innovation (basis of the newly-launched OTC Training Academy) and closed the conference by revealing the destination for next year’s event: Munich, Germany. I very much look forward to seeing some of you then, or perhaps actually much sooner, as the next stop in the OTC DASHBOARD calendar is the 52nd AESGP Annual Meeting in Athens!

OTC DASHBOARD is a subscription-only web service powered by Nicholas Hall’s DB6 Global OTC Database. To find out how we can help you to save time, work smarter and keep connected, get in touch with us today at: otcdashboard@NicholasHall.com

What Causes the INNOVATION Slowdown in OTC from OTC INSIGHT Europe

Chris INSIGHT Header 2014The April edition of OTC INSIGHT Europe contains a full round-up from Nicholas Hall’s 25th European OTC Conference & Awards, held in the beautiful city of Luzern, Switzerland, last month. Innovation – or the lack of it – was the core theme, with the majority of delegates in agreement that a new approach is required in order to boost growth in our industry.

Several expert speakers reminded us that true innovation is about a whole lot more than traditional product line extensions or marketing campaigns; at its core is the desire to solve an unmet need and make a real difference to the consumer experience. How much successful innovation of this kind have we seen in the European OTC market over the past few years?

Frustrating regulatory issues undoubtedly play a part in limiting change of this kind, especially a risk-averse approach to Rx-to-OTC switch alongside a lack of incentives such as marketing exclusivity. As well as lobbying regulators and governments to explain the real public health and economic benefits offered by OTC, healthcare companies should also embrace problem solving, creative thinking and calculated risk-taking in order to have the best chance of nurturing game-changing innovation.

You can read more on about the the events within the OTC industry in Europe in our month OTC INSIGHT Europe periodical.