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


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 This request has been voiced for several years, but manufacturers appear to be waiting for the draft guidance.


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


Q3 2017: Global OTC growth stays at 4.7%

According to the latest figures published by Nicholas Hall’s global OTC sales database DB6, the OTC market maintained 4.6% growth in MAT Q3 2017. Commenting on the results, DB6 VP Celine Waller said: “Russia remained the fastest-growing leading market, though its growth slowed slightly compared to MAT Q2 2017 (+17.3%). Brazil and Turkey (+13.1%) also both achieved double-digit growth. Growth in the US increased marginally, with an improved performance in cough & cold offset by continued weakness in gastrointestinals and dermatologicals. France and Australia (-0.7%) remained in decline – France owing to the poor performance of the large OTx sector and reverse switch of some cough ingredients, and Australia driven by a slowdown in demand from Chinese consumers buying VMS products for resale in China (daigou or ‘suitcase entrepreneurs’).”


Though OTC growth remains high in many of the Emerging Markets, the established markets of North America, Japan (+0.6%) and western Europe – notably Germany (+1.8%), France (-1.2%), Italy (+2.0) and UK (+1.7%) – remain relatively flat. Innovative Rx-to-OTC switches, such as the UK MHRA’s recent approval of the POM-to-P reclassification of Viagra Connect, or the emergence of new OTC categories, such as e-cigarettes or medical cannabis, offer the most promising route back to growth for many of these established OTC markets.

Nicholas Hall said: “Q3 data confirms 4.6% as the baseline for CHC growth, and frankly it’s not good enough!! Only the sleepiest or most risk-averse companies will accept competing in a market where growth is only modestly ahead of inflation + higher population. That is why the first serious step by Pfizer to switch Viagra is so important. Since we made our first detailed review of the ED category for a Big Pharma client exactly 5 years ago, we have been convinced that Viagra is potentially the world’s largest consumer health brand. Some might say that it already is, although that would be true only for the use of the Viagra brand name on the internet as most of the blue pills sold in that channel are not from Pfizer. As a legitimate CHC category, and with recreational use included — which Big Pharma companies dislike as they see ED brands as treatments — the overall CHC reproductive health category, including ED brands, condoms, oral contraceptives, EHC and conception products and diagnostics, could easily reach sales of US$20bn at MSP in all channels of distribution.”

OTC hearing aids: Awaiting US Senate vote


Cheaply priced reading glasses have long been available to buy without prescription in supermarkets and pharmacies. While there is an available OTC product for some living with farsightedness, there is still yet to be an approved inexpensive over-the-counter equivalent for those living with mild-to-moderate hearing loss.

Medicare and most private insurance plans in the US do not cover prescription hearing aids, which cost around $2,400 for one device. Owing to this, it is thought that many people with hearing loss go without hearing aids because they cannot afford the devices.

This could be changing soon, as the House of Representatives has passed legislation that would create a new class of hearing aids that could be sold OTC.


“We get inquiries every day from people who cannot afford hearing aids,” said Nancy Macklin, a spokeswoman for the Hearing Loss Association of America. According to a 2016 study from the National Academies of Sciences, Engineering & Medicine, just 14% of those with hearing loss use a hearing aid.

While there are several types of less expensive non-prescription personal sound amplification devices on the market, the devices are not regulated by any government entity for safety or quality standards and are used to aid people with normal hearing but wish to amplify sound.

Recent advances in technology have made the concept of less-expensive, OTC hearing aids very possible. The potential switch is part of the FDA Reauthorization Act of 2017, which the House passed Wednesday with a voice vote. The bill received widespread bipartisan support, but the Senate has yet to announce a timeline for holding a vote on the bill.

The arrival of OTC hearing aids can’t come soon enough for an ageing population that is continually growing. As Baby Boomers age and Generation X hits middle age, the number of people with mild to moderate hearing loss is increasing rapidly.

NHC North America Conference: Day 2


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!

Nielsen-CHPA Survey on OTC Allergy Trends


Coughing, sneezing, a runny nose and itchy eyes are just some of the symptoms of seasonal or chronic allergies, one of the most common ailments impacting the lives of Americans today, according to a new white paper on Rx-to-OTC allergy switches, produced by Nielsen and the US OTC industry association, Consumer Health Products Association (CHPA).

In 2015, 27.8% of Americans suffered from allergies, which translates to approximately 69 million adults, and 89 million people overall. Since 2009, a number of ingredients, including antihistamines and intranasal steroids that were only available Rx, have now switched to OTC, giving consumers more options to treat their allergies.

While there is abundant data to show that allergy OTC sales have grown significantly owing to the increasing number of brands available, there haven’t been many studies conducted to understand how these Rx-to- OTC switches have benefitted allergy sufferers.

Nielsen’s latest report assesses the consumer benefits of allergy Rx-OTC switches to help gain an understanding of allergy-suffering consumers and how having access to more oral and nasal OTC medications has contributed to their financial and personal wellbeing.

Allergy photo

The survey is made up of data based around allergy patient visits, the number of prescriptions written by month, the costs for each, and corresponding insurance-related costs. Nielsen also provided data on allergy sufferer penetration, their buying behaviour, and how each consumer treats their ailment. 
A survey was also fielded to 2,000 adult allergy sufferers to better understand their treatment routine and overall satisfaction with their medication options.

The report found that more and more Americans are suffering from allergies. Over the time period analysed, the number of individuals who stated that they suffer from allergies has increased. There are approximately 9.7mn more allergy sufferers today than there were
 in 2010.

There has also been a clear shift to OTCs. 
The number of allergy sufferers taking OTCs has increased, while 
at the same time the number of sufferers taking prescription medications has declined. Just as importantly, the report also found that allergy sufferers who take OTCs are highly satisfied with the medication options available to them.

The report is available to download here.

OTCs in Action Episode 25: Switches empower European Women, Brazilians


Women are empowered by OTCs this month as Nicholas Hall’s OTC.Newsflash reports that ellaOne (HRA Pharma, ulipristal acetate) emergency hormonal contraceptive became available without a prescription in France, the UK, Germany, Ireland and Poland, following the EU centralised switch in January 2015. At our recent Paris conference, Nicholas Hall & Company awarded ellaOne the Most Innovative European New Product of the Year.

In France, a survey by Harris Interactive found that, although 94% of French women aged 15-50 years are aware of EHC, 65% believe that they are misinformed on the subject, and 78% would like more information. However, ellaOne cannot be advertised, since under French regulations, it’s a “semi-ethical” drug that qualifies for partial insurance reimbursement when prescribed. Approved in mid-April, ellaOne will be promoted in France via a website, Facebook and Twitter.

Separately, effective 1st April 2015, ellaOne is available direct from pharmacies in the UK & Ireland without the need for a prescription. Alongside this move to pharmacy OTC status, the NHS and trade price of the emergency hormonal contraceptive is reduced from £16.95 (US$25.48) to £14.05 (US$21.12).

In Poland, Health Minister Bartosz Arlukowicz has signed a decree authorising the non-prescription sale of ellaOne, although this is limited to those aged 15+ years. Legislation came into force on 16th April 2015.

In related news, Brazil’s regulatory group, ANVISA, has proposed a new framework for Rx-to-OTC switch. Nicholas Hall’s Network Partner in Brazil, Henry Adler, explained: “ANVISA’s intention is to make sure that all products reclassified as OTCs are actually switched or lose their registration. And that applies to those products that are legally OTC but continue to be treated as if they are Rx or OTX. So, ANVISA is finally getting round to cleaning up the market: soon there will be Rx, OTCs, generics and equivalents. The aim appears to be to increase competition and keep prices low. In that way, the Ministry of Health will work towards its strategic objective of increasing the population’s access to medicines.

Currently, an OTC must be listed by therapeutic group and indication in the List of Groups & Specified Therapeutic Indications, which has not been updated since 2003. Open for Public Consultation until 15th June 2015, the proposed regulations include:

  • OTCs, their active principles and their indications will be defined by ANVISA according to the Guide to Therapeutic Classes of OTCs (GCTMIP)
  • To be considered for switch, medicines must have been sold for at least 10 years under prescription in Brazil, or OTC or Rx in countries whose regulatory agencies have a co-operation agreement with Brazil, and have demonstrated a high safety profile
  • Once approved, switched products must be dispensed by the pharmacist for 12 months
  • New medicines may come to market straight away as an OTC if they meet relevant safety requirements
  • ANVISA will update the GCTMIP periodically, but at least at yearly intervals. Companies marketing products that can be switched following changes in the GCTMIP have 180 days to reclassify them. If they fail to do so, their product registration will be cancelled.

Meanwhile, in the US, we await Pfizer’s decision on whether or not it will attempt to switch Lipitor (atorvastatin) from Rx-to-OTC. Last year the company conducted a clinical trial to determine the viability of the switch. Over the years, other marketers  have tried to pioneer the Rx-to-OTC switch of this class of drugs …. watch OTC.Newsflash and sister weekly bulletin OTC.NewDirections, which focuses on switch and science, for the latest news.

OTCs in Action Episode 20: Goodbye to a pioneering OTC


It’s with sadness we observe the discontinuation of Oxytrol for Women overactive bladder treatment, which Bayer acquired through the purchase of MSD’s consumer health brands last year. While it’s true that the oxybutynin transdermal patch never generated the level of sales MSD hoped for, it will be remembered as an important Rx-to-OTC switch because it created a new OTC category for millions of women suffering from OAB.

In late 2012, I learned about the pervasiveness of the condition when I covered the FDA’s Nonprescription Drugs Advisory Committee hearing on the Rx-to-OTC switch of oxybutynin:

Oxytrol for Women: Benefits of OTC status
According to MSD, OAB is an important public health issue with an estimated 20mn women in the US suffering from symptoms, which include urinary urgency, and is usually associated with urinary frequency and waking at night to urinate. The median age of OAB sufferers is 52 and many women incorrectly assume it is an untreatable aspect of ageing. Anthony Visco MD, president of the American Urogynecologic Society, said it is a myth that OAB is a normal part of ageing and that the potential benefits of OTC Oxytrol for Women outweigh the risks.

Elizabeth LaGro, Director of Communications for the Simon Foundation for Continence, explained that the majority of women suffering from OAB wait seven years to report the problem. In the meantime, it has a “tremendous effect on their lives”. Normal activities stop, she said, when women are afraid they will not be able to get to a bathroom. They suffer isolation, depression, anxiety and embarrassment. Younger women suffer strained marriages and many families are unable to go on outings. “OTC treatment of OAB will help, maybe for the first time, women manage their conditions, rather than coping with it,” she concluded.


The OTC industry prides itself on meeting consumer needs. Let’s put OTCs in Action to take the next step in this category and develop a lasting OTC treatment for women and men suffering from bladder control problems.

For more information about Nicholas Hall & Co’s OTC INSIGHT NORTH AMERICA, click on the link below: