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 This request has been voiced for several years, but manufacturers appear to be waiting for the draft guidance.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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AESGP meeting 2018: Key learnings

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OTC INSIGHT Europe Editor Sarah Carter reports back from this year’s 54th AESGP Annual Meeting, which was held in Amsterdam and served as a farewell to Dr Hubertus Cranz, who retired as Director General after 30 years in the role.

Below are 8 key learnings from the meeting:

  1. Representatives from Pfizer and Hexal / Sandoz demonstrated how Rx-to-OTC switch can act as a growth driver for the consumer healthcare industry, with Nexium Control (EU Centralised Switch) and MometaHexal (Germany) given as case studies. Both asserted that the Rx heritage of the brands was instrumental in their successful switch, with both market leaders in their respective Rx spheres.
  2. However, while switch offers growth opportunities, several speakers stressed that the limited 1-year data exclusivity available with a switched product in the EU can deter marketers from making the timely and costly investment needed to switch their product.
  3. Digitalisation has transformed the rules of the healthcare industry and education. According to Google, search engines and online videos are the most important touch points for OTC purchasers, with one in 20 searches on Google related to health. In 2017, there were 40bn healthcare queries in EMEA alone.
  4. The global volume of healthcare data doubles every 18 months. It is crucial that we build trust with consumers regarding Big Data, ensuring that our industry uses this in a responsible manner, particularly salient given the introduction of the EU’s General Data Protection Regulation on 25 May 2018.
  5. Low levels of health literacy act as a barrier to self-care. We must empower consumers with the tools and knowledge necessary to play an active role in their health management, healthy ageing and prevention. Healthcare systems need conscious individuals who actively pursue a healthy lifestyle, and seek HCP advice where necessary.
  6. Technology such as wearables and apps has helped to raise health awareness and engagement among consumers, driving the trend for wellness and encouraging people to become key actors in their health management. In the industry, we see increasing purchases of long-term preventive products, rather than OTC treatments.
  7. It is vital that we understand the consumer at a much deeper level than we have done historically, as they no longer want to be sold to, but engaged with. The advent of Big Data and AI deliver us new tools to generate insights and ultimately create more meaningful connections and stronger relationships.
  8. There is little to report on regulations — still no decision on botanicals, and no real update on medical device regulations.

Only two weeks to go until the annual North American OTC Conference! Hosted by Nicholas Hall and Everything Health in Morristown, New Jersey, 20-21 June, this highly-anticipated meeting will review crucial topics impacting the competitive landscape around the central theme of The Future of Consumer Self-care: New OTC Solutions. With topics on the agenda including the e-commerce revolution, a presentation on “Magical Marketing in Healthcare” from Google and a look at the industry’s ‘Switch wish list’, this promises to be an event you can’t afford to miss. To receive a copy of the full meeting agenda or to reserve your place now, contact lianne.hill@NicholasHall.com

OTC benzocaine teething gels withdrawn in USA

In late May, the FDA issued a warning to consumers that OTC teething products containing benzocaine pose a serious health risk to infants and children. The agency said that all oral products containing the pain reliever for temporary relief of sore gums owing to teething should no longer be marketed and is asking companies to stop selling them for this use.

Additionally companies are being requested to add new warnings to all other benzocaine oral health products to describe serious health risk of methemoglobinaemia, a blood disorder that impairs the body’s ability to use oxygen that has been linked to benzocaine use.

Affected brands include Anbesol (Pfizer), Baby Orajel and Orajel (Church & Dwight), Cepacol (Reckitt Benckiser), Chloraseptic (Prestige Brands), Hurricaine (Beutlich Pharmaceuticals), Orabase (Colgate) and Topex (Sultan Healthcare), as well as store brands and generics.

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Figures from Nicholas Hall’s global OTC database, DB6, indicate that the US mouth & dental analgesics category was worth US$126mn in 2017. Before this latest warning, sales were already in decline (-4%) owing to an FDA warning on homeopathic teething products in September 2016. Standard Homeopathic has now re-entered the market with the launch of Hyland’s Baby Oral Pain, 4Kids Oral Pain Relief and 4Kids Oral Pain Relief Nighttime Tablets without belladona or benzocaine. 

Orajel (Church & Dwight) is the leading brand with a 56% share of sales and, according to DB6, some 90% of all mouth & dental analgesics in the US are currently formulated with benzocaine, including the leading brands Orajel and Anbesol. On its brand website, C&D stated that Orajel Medicated Teething Gel, Orajel Medicated Nighttime Teething Gel, Orajel Medicated Daytime & Nighttime Teething Twin Pack and Orajel Medicated Teething Swabs had all been discontinued with immediate effect.

Comment from OTC.NewDirections Consulting Editor, Nina Stimson: This move was probably inevitable, given safety concerns and earlier action against other children’s meds such as cough remedies, but it’s likely to cause a few sleepless nights for parents, teething babies and marketers alike until they figure out the way forward … Official advice to parents now suggests that they should gently massage infants’ sore gums but avoid medication. We think quite a few may turn to a children’s or infants’ systemic analgesic …

To stay up-to-date with the latest regulatory changes, subscribe to OTC.NewDirections, and also meet like-minded professionals at our 1st OTC.NewDirections Executive Conference in London on 12th September 2018Where Innovation meets Regulation. Nicholas Hall and Nina Stimson will be joined by representatives from players including Angelini, Kanabo Research and Medical Brands to review, discuss and debate the major issues impacting innovation, regulation and competition. Sessions cover diverse topics such as New Product Opportunities, Regulatory Affairs (including Switch), Medical Devices and Digital Health, plus Herbals & Naturals and the fast-developing Medical Cannabis market. Book now and benefit from our early bird discounts by contacting lianne.hill@NicholasHall.com

Probiotics behind VMS upturn in 2017

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In the three prior years (2014-16), sales of vitamins, minerals & supplements grew at a slower pace than the global OTC market as a whole, but this trend changed in 2017, when VMS achieved a slightly higher rate (+4.2%) than the global average (+4.1%). VMS was the only major OTC category to see growth improve in 2017 – analgesics, CCA, Derma and Lifestyle OTCs all reported significant slowdowns – and three of the Top 10 best-performing OTC subcategories in 2017 were in VMS: Probiotics (+9.4%), tonics & cure alls (+7.6%) and single vitamins (+5.8%).

Probiotics added another US$330mn in sales in 2017 to create a global market of US$3.8bn, and have maintained high growth thanks to new products with unique positioning, innovative delivery formats and growing awareness of the benefits of probiotics in fast-growing countries like Brazil (+11.7%) and India (+10.4%). Although probiotics growth slowed in several mature markets in 2017, such as Italy, Japan and Germany, it remains high in the world’s two largest arenas for probiotics sales: USA (+10.2%) and China (+14.1%).

Top 5 probiotics markets 2017

One of the hotbeds for probiotics innovation in Q2 2018 has been India. Setu (OmniActive Group) recently launched probiotic supplement YourGut, positioned to assist in balancing intestinal microflora for overall digestive and immune health. Formulated with 9 bifidobacteria and lactobacilli strains, at a dose of 15bn CFUs, YourGut is available in tubs of 30 vegetarian capsules.

Another recent launch came from Sundyota Numandis with SuperFlora GG, containing Lactobacillus GG (ATCC 53103), which can be administered to newborn babies from 1 day old to treat gastroenteritis and antibiotic-associated diarrhoea. Rakyan Beverages, marketer of the Raw Pressery range of cold-pressed juices, also announced last week that it was rolling out a new probiotic drink in India. Thanks to this spike in new product activity, India’s probiotic category looks on course for an even stronger year in 2018.

To find out more about the innovations that are supporting this high growth in the probiotics market, contact Owen (owen.hartnett@nicholashall.com) to arrange your free trial of our OTC New Products Tracker database.

ROW growth accelerates to 6.7% in 2017

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One of the core benefits of your OTC DASHBOARD subscription is unrivalled coverage of the OTC market in the Middle East & Africa. Sales in this region now total US$8.8bn, following an impressive 6.7% upturn in 2017, and below we highlight some of the key recent trends & developments in this dynamic region.

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Two of the region’s Top 5 markets, Turkey and South Africa, feature in the global Top 20 and both outpaced the regional trend in 2017. Turkey’s OTC market was particularly dynamic, partly driven by price inflation but also rising volume sales, thanks to growth in consumer spending and also strong investment from multinational OTC marketers, who compete with well-established local companies like Abdi Ibrahim and Santa Farma.

As well as double-digit growth in Turkey, where Bayer is the No.1 marketer, there were also strong performances from Algeria (+10.0%), Egypt (+16.4%) and Nigeria (+8.2%). GSK occupies a strong position in Egypt and Nigeria, thanks largely to the popularity of painkillers such as Panadol, and is committed to expanding its OTC portfolio and widening distribution.

Sanofi is the leading OTC marketer in Algeria, again thanks to a well-established analgesics portfolio (Doliprane and Aspegic), in addition to a fast-growing CCA range. Overall, GSK, Sanofi and Bayer are the standout OTC marketers in the region, joined by South Africa’s No.1 Adcock Ingram and RB.

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For a deep dive into our Q4 2017 data and trend reporting on all Middle East & Africa markets, be sure to log on to the OTC DASHBOARD website or app (which can be downloaded on Apple or Android smartphones).

Q4 2017 Update Now Live!

We’ve just updated the OTC DASHBOARD website with full-year 2017 data and trends for all regions and all 64 countries that we track worldwide. There’s no better way to start exploring this vast reserve of information than our new homepage, which provides at-a-glance global OTC sales by region, marketer and category, as well as an interactive global map with data on the Top 20 countries. Here, we round up some of the highlights from the latest Q4 2017 update.

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One of the major trends in Q4 2017 was the drop-off in global OTC growth. A 4.1% rise in 2017 was the lowest annual growth for the global OTC market since 2014, with Europe (+2.7%) and North America (+2.9%) at the heart of the slowdown. Asia-Pacific was up 4.3%, while the two smallest major regions – Latin America (+11.8%) and the Middle East & Africa (+6.7%) – grew fastest.

Looking at categories, Derma (+2.5%) underperformed most, while CCA growth slowed to just 4.3% by end-2017, with vitality continuing to drain out of allergy remedies (+3.1%). Cough remedies (+5.4%) and systemic cold & flu (+4.0%) also reported much lower growth by year-end, especially in Europe.

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The overall shares of the global OTC market by major category remained stable in 2017. Analgesics (+4.5%) and Lifestyle OTCs (+4.5%) were the main driving force behind OTC growth, and the Rx-to-OTC switch of Viagra Connect in the UK in 2018 bodes well for development of the erectile dysfunction category. GIs advanced by 4.3%, while VMS (+4.2%) produced another year of solid growth.

As for marketers, the Top 5 remained unchanged in 2017 despite further M&A activity and speculation; in Pfizer’s earnings call yesterday, CEO Ian Read said he has not yet received an acceptable offer for the OTC business and may decide to retain it. The major recent M&A news was that P&G has agreed to buy Merck KGaA Consumer Health and at the same time to dissolve its PGT joint-venture with Teva. By our calculations, the new P&G will rank 7th in the global OTC marketer rankings by value, and the new Teva (assuming it retains its OTC business) will rank 12th.

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Other highlights:

• Looking at OTC brand rankings, analgesics Tylenol and Advil – both of which are former global No.1 OTC brands – now trail by a fair distance behind new No.1 brand Vicks, which grew by 12% in 2017

• Abbott moved ahead of Merck KGaA to claim a spot in the global OTC Top 20, following dynamic growth of 10.6%, including double-digit rises for laxative Duphalac in Russia and antidiarrhoeal Pedialyte in the USA

Log on to OTC DASHBOARD now for access to all Q4 2017 data and trends.

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