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 This request has been voiced for several years, but manufacturers appear to be waiting for the draft guidance.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

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

Competition rises in sleep devices category

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Now available to buy in the US and selected European markets via the Nokia Health store, the new Nokia Sleep device is a sensor pad that can be placed under the mattress to monitor sleep patterns, track heart rate and detect snoring. 

It also syncs up to Nokia’s Health Mate app and provides smart home control via IFTTT (if this then that) integration, which allows for automatic thermostat regulation and light adjustment. The app also allows the user to view their Sleep Score to get an insight into what makes a good night’s sleep and how to improve night after night.

Packaged as a sensor pad with USB charger, Nokia Sleep retails at $99.95 (USA), €99.95 (Europe) and £99.95 (UK), and the brand website indicates that there are plans to roll out the product in key Asia-Pacific markets like China and Japan.

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Facing stiff competition in the smartphone market from Apple, Google and Chinese manufacturers, Nokia – the former king of mobile phones – is looking to further diversify its business.

Nokia Sleep was due to launch earlier this year, but news of a strategic review of Nokia’s Digital Health business in February 2018 put the rollout in doubt. Nokia will be monitoring closely how this new product fares against established competitor Beddit, which was acquired by Apple in 2017.

Whether you want to find out more about the latest innovations, benchmark the competition or simply keep abreast of new launches, Nicholas Hall’s extensive OTC New Products Tracker is an essential competitive intelligence tool that you simply must trial. Subscribers can also benefit from a newsletter highlighting the key product innovations affecting the industry. Find out more or set up your free trial today by contacting david.redford@NicholasHall.com

Will the new WebMD Symptom Checker impact self-care?

WebMD has recently launched a new version of the iconic Symptom Checker. The tool, which has been available since 2005, has been redesigned to make it easier for the user to operate and help generate more accurate results.

The site receives on average 75mn visits per month and provides people with access to the latest health information, news and trends. The Symptom Checker aims to help people find out more about possible conditions to be best informed on what steps to take next.

The new WebMD Symptom Checker features an improved interface designed to provide visitors with a simple and seamless experience, powered by a professional-grade diagnostic engine used by physicians to support their point-of-care decisions.

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WebMD’s new, improved interface

The new Symptom Checker features three times more symptoms and potential conditions than the previous version. WebMD has also added a search bar, which allows users to manually type in how they are feeling rather than having to connect specific areas of the body with specific alignments, for example in the case of general bodily aches.

WebMD redesigned the tool based on feedback from WebMD users, medical experts and leading academics and researchers. Additionally, an article by The British Medical Journal regarding symptom checker tools was also consulted.

Steven L. Zatz, CEO of WebMD, said: “Our redesign reflects our commitment to continually improving the experience of consumers when seeking answers to their health questions. We take very seriously our role in the consumer healthcare experience, and we have enhanced the tool to deliver the most accurate results possible.”