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!

NHC North America Conference: Day 1

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Here we bring you a review of our first regional North American OTC Conference, which took place last week in Morristown, New Jersey, America’s central business hub for consumer healthcare.

Nicholas Hall opened proceedings with his Keynote address and annual report, reviewing recent successes in the US market, and noting a particularly successful cough and cold season. He also delved into the seven market drivers leading the current growth in OTC, the most popular being consumption by women and the ageing population.

This was followed by a gloves-off panel discussion, hosted by Mike Tarino, Principal of Tiltas Solutions. Mike was joined by Sandra Morris, former Senior Benefits Manager at Procter & Gamble, Mike Thompson, President & CEO at National Alliance of Healthcare and Dennis Marco, Managing Partner of Hamilton Public Affairs. The panel discussed and challenged what the administration of Trump meant for consumer healthcare and OTCs. Tarino highlighted drastic changes impacting US healthcare, with the costs for a family of four seeing a near US$20,000 increase in the past 16 years.

Ed Rowland provided an update on Boots UK and implications for the Walgreens Boots Alliance in the US, exploring the differences in UK and US marketing. Scott Emerson, Founder & CEO of the Emerson Group, shortly followed with a presentation on Innovation and how it isn’t quite what you think! Scott asserted that we need to think about what it is consumers are looking for in their products. Brands need to question their white space and ask ‘is it truly white space?’ when it comes to being innovative in branding. Scott also stressed that we must not be afraid to be patient when it comes to launching new products.

Finally, seeing us into our lunch hour, Geoff Betrus, Senior Director Shopper Solutions and Lynn Hall, Senior Director of Health and Wellness Solutions, both of J&J, explored consumer healthcare and retail partnerships, and how these can be integrated to deliver new consumer solutions. Geoff explored the current diabetes epidemic, emphasising the importance of Diabetes wellcare and how education for diabetic patients / carers is vital in understanding how to live with the disease. Lynn addressed the need for marketers to help people change their behaviour and attitudes towards their well being, and how this is something that can be achieved through motivation enhancement – that is to say by enhancing our abilities and creating opportunities.

After an informative morning, our delegates once again congregated for an afternoon of presentations focusing on reaching new heights in consumer healthcare. The afternoon session began with Monica Wood, VP Global Consumer Healthcare and Member Insights for Herbalife Nutrition, detailing key learnings for OTC companies in benchmarking the direct selling industry to generate sales. Monica was swiftly followed by Tine Hansen-Turton, who discussed the value proposition of convenient care and how retail-based healthcare clinics can build a culture of consumer-driven healthcare.

After a brief networking break and injection of caffeine, Thierry Garrier, Director of Marketing, Dietary Supplements NA at DSM, presented some of the new technological advances in consumer healthcare, such as bone density scanners, blood cholesterol testing and lutein vision health, an area of tremendous growth. Thierry also showed us Vitascan, a finger prick blood test which gives results in ten minutes on a smart phone! Certainly food for thought in an industry constantly searching for the latest unique selling point!

Our closing presentation from Patrick Spear, President & CEO for trade association Global Market Development Centre, analysed how health & wellness can be packaged as a retail strategy, allowing marketers to meet consumer expectations. Patrick discussed the difference between the ‘consumer’ and the ‘shopper’, emphasising that the consumer holds the ambition but the shopper holds the reality of the purchase. Patrick also analysed some of the ‘disruptive innovations’ in the OTC industry; products such as wearables, which 70% of millennials now own. Patrick insisted that we must navigate towards health & awareness in the industry, enhancing transparency by connecting, collaborating, creating and using commerce.

Self-care in Canada: Meandering Path to New Regulations

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Mathematically, the shortest distance between two points is a straight line. However, in public policy it is rare to chart such a clear direction. Reading through the “What was Heard” report from Health Canada’s public consultation on self-care regulation, which was conducted online in late 2016, there does not appear to be any real consensus over new proposals for an overhaul of all the regulations for non-prescription medicines, Natural Health Products (NHPs) and cosmetics.

Although the report was completed months ago, it was only released in late March this year, as a backgrounder to a series of town hall style discussions on a more detailed set of changes starting 4th April. While the government has developed a more detailed set of proposals that address some of the concerns set out in the report from last year’s consultation, it would appear that those attending the provincial feedback forums will not have the opportunity to digest these details prior to giving their advice. In fact, one of the key findings of the report was that all stakeholders felt that the original outline lacks enough specificity to make cogent comment.

Reading the report, it is interesting how what was heard may not actually be fully representative of what was said. For example, the report concludes that “many participants in the consultation see considerable value in the clarity that would be provided by a single regulatory approach to all three affected areas” (i.e. cosmetics, NHPs and OTCs). What the data show is that in virtually all stakeholder categories, the support across several key measures was only around 30%. Taken another way, roughly 70% or more of the stakeholders would not be more confident in these proposals.

The report notes that most of the concerns came from the NHP segment. This should not be a surprise since all previous consultations were only about moving OTCs out of the prescription drug regulations. For non-prescription medicines, this was round two of the discussions but for the NHP and cosmetics sectors this was novel territory. The visceral reaction was clear given that the NHP community spent years developing a set of regulations independent from drug classification and achieved it through a parliamentary process. They perceived that rolling all OTCs and NHPs into one single regulation was a step back in time, especially given the tone of the documents about claims-based barriers to market access.

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There weren’t many points where all stakeholders agreed. However, it seems there was a strong consensus that self-care products (OTCs, NHPs and cosmetics) “should not be regulated in the same manner as prescription drugs”. Far from an epiphany, this was the basis for the idea that OTCs should be granted their own regulations outside the prescription regulations, just as NHPs were granted such regulatory status. Cosmetics have never been in the prescription drug framework.

There was no consensus on the specific elements of the new framework. The risk-based approach was supported to the degree that most agreed that “products which pose a greater risk of harm should receive greater scrutiny and be subject to significant requirements”. Where the consensus fell into disarray was around the confusion between evaluating products for their individual risk and categorising products broadly into risk levels. The proposal seemed to set out a lower-risk category where claims would be limited and as such the government would not review and license them for sale. This type of product would be supported by pre-cleared information such as monographs.

The logic suffered in some stakeholders’ view since the model would seem to require lower-risk products to move into higher risk categorisation when clinical data would be provided to create greater confidence in the claims. The report notes that “there is no consensus that the proposed risk-based approach would create more confidence when purchasing self-care products”. In fact, 82% of consumers and healthcare professionals and 93% of cosmetics manufacturers said it would not give them more confidence.

The thought of requiring only “scientific” proof to justify health claims met with resistance from most stakeholders (except the five OTC drug companies). Only 30% of all respondents agreed with this notion and that was not highly differentiated across several segments. The support for stricter reliance on “science” (not defined but often assumed to be clinical trial data) was low with consumers (30%), healthcare professionals (33%), NHP companies (21%) and cosmetics manufacturers (30%). On the other side of the argument, academics and researchers were more supportive (60%).

A concept floated by government was that they would not evaluate and license certain types of products based on the types of claims being made. This was suggested to be accompanied by a disclaimer that Health Canada did not assess the claim. While cosmetics already enjoy a similar notification system, most stakeholders didn’t appear to support adopting a cosmetic-like system for OTCs and NHPs. The report notes that “participants are somewhat divided on the use of a disclaimer on products whose efficacy would not be reviewed”.

Despite the lack of consensus on a disclaimer, there would appear to be acceptance that changes could be made that would “facilitate informed consumer choice”. Some stakeholders have proposed adding labelling statements that would make it clearer when traditional evidence was used to support the claim. This, they feel, would add information that enhances consumer choice.

This consultation elicited a very strong response relative to most government consultations. Perhaps this was influenced by the fact that during the consultation period, Health Canada put out a very strong social media campaign and used traditional media stories to “clarify” some aspects of their proposals. With the communications efforts to ensure that the consultation garnered significant and reasoned responses, it should give some confidence in the results.

Perhaps one of the most telling observations related to the confidence stakeholders would have in the newly designed system. Consumers (78%), healthcare professionals (75%), NHP companies (80%) and cosmetics firms (63%) did not feel more confident with the new proposals. In a similar vein, 82% of consumers didn’t feel that the proposals adequately addressed their needs. The numbers were similar for healthcare professionals (78%), NHP companies (81%) and cosmetics businesses (74%). Only two OTC companies felt that their concerns were addressed.

The report concludes that “there is clearly a need for further detail on the proposed approach so that stakeholders may provide more specific feedback to Health Canada as the framework continues to be developed”. No doubt this is true and, as the government heads into the next phase of face-to face discussions, it would have been helpful to have that kind of detail available before asking stakeholders to respond.

FDA takes steps to improve hearing aid accessibility

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The U.S. Food and Drug Administration (FDA) have announced important steps to better support consumer access to hearing aids. The FDA will consider creating a category of OTC hearing aids that could deliver new, innovative and lower-cost products to millions of consumers.

The agency also announced important steps to better support consumer access to hearing aids. In a guidance document, the agency explains that it does not intend to enforce the requirement that people aged 18+ years receive a medical evaluation or sign a waiver prior to purchasing most hearing aids. Under the new guidance, the FDA will continue to enforce the medical evaluation required for people under 18 years of age.

The agency also requires that consumers are provided with information and instructions about hearing aids before any purchase from a licensed hearing aid dispenser. This guidance is effective immediately.

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FDA Commissioner Robert Califf, M.D commented “Today’s actions are an example of the FDA considering flexible approaches to regulation that encourage innovation in areas of rapid scientific progress,”Califf continued “The guidance will support consumer access to most hearing aids while the FDA takes the steps necessary to propose to modify our regulations to create a category of OTC hearing aids that could help many Americans improve their quality of life through better hearing.”

The FDA has cited that hearing loss affects some 30 million people in the United States and can have a significant impact on communication, social participation and overall health and quality of life.

British Columbia Pharmacists Could Provide Abortion Pills

The British Columbia College of Pharmacists has been working with Canada’s Department of Health to make the combination of mifepristone and misoprostol (for the termination of a developing intra-uterine pregnancy up to a gestational age of 49 days) available directly from a pharmacist.

The product, Mifegymiso (Linepharma International), was approved by Health Canada in 2015, and was placed on the Prescription Drug List (PDL). The provincial drug schedules also classified the two ingredients as prescription drugs (requiring a physician’s intervention).

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The College of Physicians and Surgeons of B.C. and the College of Pharmacists of B.C. have been working behind the scenes for months to find a way to circumvent the federal drug regulator’s plan for physician-only dispensing of Mifegymiso. Abortion advocates say that because most doctors’ offices are not equipped to act as miniature pharmacies, the dispensing requirement is likely to discourage physicians.

It seems that the intention may be to work around the regulations, though this may not be well received by federal regulators. Health Canada also advised that working around the regulations would have an impact on the liability of pharmacists.

Mifepristone has been approved in more than 60 countries, including the United States, where it has been available since 2000. Canada did not approve the drug until July 2015, and manufacturing issues have since delayed its sale.

Esomeprazole, Ibuprofen OTC Changes Take Effect In Canada

In February this year, Health Canada announced its intention to make two changes to the Prescription Drug List (PDL). Specifically, it was proposed that the PDL be amended to allow an OTC version of esomeprazole for heartburn and to make technical changes that would permit modified-release ibuprofen products available for self-care.

While this announcement was not a surprise as the six-month period for comment elapsed on 5th August, the delay in making the change effective (18th August) was more likely owing to administrative matters than anything therapeutic in nature. The two changes to the federal list are as follows:

  • Esomeprazole or its salts except when sold for the 14-day treatment for frequent heartburn at a daily dose of 20mg
  • Ibuprofen or its salts except:
    1. An oral dosage form that provides 400mg or less per dosage unit; or
    2. A modified-release oral dosage form that provides 600mg or less per dosage unit

While the Federal decision had no further restrictions attached, the provincial scheduling of these products do take on some further limitations as decided by the National Association of Pharmacy Regulatory Authorities (NAPRA).

Now that the federal switches are finalised, the interim decision made by NAPRA becomes effective. Specifically, the provincial decision on these two items were:

  • Ibuprofen or its salts, when sold in a modified-release oral dosage form that provides 600mg or less per dosage unit would be placed into Schedule III (sold only where a pharmacist is present)
  • Esomeprazole or its salts, when sold for the 14-day treatment for frequent heartburn at a daily dose of 20mg, in package sizes of no more than esomeprazole 280mg would be assigned to Schedule II (available only from a pharmacist directly)
  • Esomeprazole or its salts, EXCEPT when sold for the 14-day treatment for frequent heartburn at a daily dose of 20mg in package sizes of no more than esomeprazole 280mg will not be switched provincially (it will remain in Schedule I – Rx only)

The ibuprofen decision was notable since the regular dosage form is available as an unscheduled item (available through any outlet when sold in package sizes of up to 18,000mg) while the modified release product is restricted. The esomeprazole decision matched the decision made for omeprazole in 2014.

OTCs in Action Episode 58: Spots on her face

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OTCs are in Action this week in parental thinking: “You don’t need a new iPhone … those shorts are too short … those heels are too high … too much make-up!” Sometimes it seems I say no to everything my teenage daughter wants … but acne products for my lovely girl’s complicated complexion – I’ll buy anything!

So, Galderma’s proposal to launch an OTC gel version of the acne-fighting ingredient, adapalene, caught my attention. The Nestlé-owned company will present its case for switching the ingredient from Rx to OTC at the 15th April meeting of the FDA’s Nonprescription Drugs Advisory Committee. It currently markets adapalene-based OTC, Differin, in Russia and Greece. According to Nicholas Hall’s DB6 global OTC sales database, the brand generated sales of $2mn in Russia in 2014, and $1mn in Greece.

In the US, Galderma’s Rx portfolio currently uses adapalene in Rx acne treatments Epiduo (0.1% and benzoyl peroxide 2.5%), Epiduo Forte (0.3% / 2.5%) and Differin – available in 0.1% and 0.3% strengths.

If anyone needs a touching reminder of those terrible teen troubles, join the 3mn viewers of Charlie McDonnell’s acne song (which sported a pop-up ad for Neutrogena skin care brand from J&J during my last visit to the site).