My Summary of Day 2 and the overall North American Conference 2018

Joseph McGovern, VP, Strategy, at Everything Health, kicked off proceedings on Day 2 with a review of the key issues in switch.

Joe stressed that Rx-to-OTC switch can give new life to a drug and is a way of benefiting public health too. There are two sets of issues that emerge with switch – how to make money from it and how to register it? Every switch has issues and every switch is a new encounter. Issues include compliance, drug interactions, a need to know individual data, a risk if diversion from care and the importance of recording who is on treatment for public health outcomes. But switch can create opportunities to address public health issues and boost business. We need new and creative regulatory solutions. The good news is that consumers are open to technology use – we need to utilise this. Fundamentally the consumer-centric business model has to evolve. Our business is about making more and more pills – but we need to add value. OTCs have a big future but a different future involving technology and new channels. This involves risk but also opportunity.

 Vidhu Dev, VP, Rx-to-OTC Switch, R&D at GSK then presented on the industry’s wish list – including a desire to expedite “fast-read” FDA meetings with sponsors, encouraging early exploratory meetings without requiring lengthy briefing books.

There is also hope for a consideration to allow for deviations in the OTC label vs the original Rx label. Other wishes included increased disclosure and transparency from FDA on risk / benefit and faster implementation of NSURE initiative for Rx-to-OTC switches. Vidhu also asked how the cost and timeline of switch be shortened? There is an opportunity to reduce labelling and behavioural study costs potentially by using technology by allowing more virtual interviews, maximising social media etc.

Finally, Vidhu talked about the BTC class. The position on BTC from FDA has always been this doesn’t seem like the right thing for US, the industry feels it is restrictive. But from a futuristic point of view and with online access, virtual doctors, remote monitoring, telemedicine etc do you need a live person to help make a self-selection decision at purchase?

Joe Gitchell, President of Pinney Associates, discussed the future of the nicotine category. Joe said that new technology has freed nicotine from smoke. We could massively reduce preventable disease but inadvertently increase addiction – this may end up rewarding the companies that create the problem in the first place.

The good news from FDA is in July 2017 a comprehensive plan on nicotine was announced. The plan is base of this is that nicotine alone is not the health problem – smoke is! The plan “solves” for the problematic combination of addiction and premature death. Some options include introducing cigarettes with low levels of nicotine or making nicotine non-combustible. The FDA implicity sets the No.1 goal as reducing premature death and disease and this has broader implications and opportunities for self-care.

Michael Hufford, Co-Founder & CEO of Harm Reduction Therapeutics, gave his case for OTC naloxone. He highlighted the severity of the opioid crisis, with 115-177 deaths per day – more than car accident deaths. Naloxone is a highly safe and effective opioid antagonist. However, he showed the “Tale of Two Markets” – while the price of heroin has fallen, the price of naloxone has risen. Meanwhile, the potency of heroin has increased over time. But naloxone has remained unchanged since approval in 1971. Naloxone is “sort of” BTC – available on standing order in pharmacies, yet it is difficult to obtain. Also drug addicts may not want to talk to pharmacists. The FDA has been very clear they want to see it move to OTC. Harm Reduction Therapeutics is working on bringing a low-cost OTC version to market to improve access to everyone.

Following a coffee break, Coleman Bigelow, Senior Partner Lead – Healthcare Team at Google, showed how we can provide magical digital experiences along all the stages of the patient journey, in the age of the “best” and the land of “now”! Patients show intent across the journey of symptoms, diagnosis, treatment and management. As an industry we need to tap in to that.

Mary Alice Lawless from Everything Health summarised the meeting with a compelling call to action for OTC marketers to Change the Words; Change the World! Mary suggested to both be successful and have fun we need to be daring and courageous. Consumers are empowered by technology, smarter about spending & enhanced convenience, expect unique needs to be addressed, and willing to exchange data for benefit of improved experience. In self-care we haven’t yet figured out how to address the consumer in this new world. CHC needs a shared vision with solutions and consistency. On that note, Mary Alice introduced the launch of The Consumer Access Consortium in partnership with Nicholas Hall and other partners such as The Foundation for Health Smart Consumers, Biograph Inc and the NCPDP. This would take the form of online portals to check for cross indications, connect with consumer and allow the consumer to purchase a brand via various channels. In this way it brings together personalisation and technology, two of the key themes of the meeting.

In concluding proceedings, I illustrated what an amazing opportunity we have, but first we need to find out how we can break out of this low growth. This led me back to my opening remarks – as an industry we need to pick up the PACE!

As we close with a Networking Lunch, I hope to see many of our delegates and speakers join us again in 2019. Many thanks to all who joined us to make the past few days such an astounding success.