OTCs in Action Episode 39: OTC launches modest but meaningful in Denver

OTCinActionheaderOTCs are in Action this week in the beautiful city of Denver, Colorado, where the National Association of Drug Stores is convening its Total Store Expo. Sunday morning, NACDS Chairman of the Board, Randy Edeker, chairman, CEO and president of the Hy-Vee pharmacy chain, told the story of how he always researches his illnesses and how to treat them, so when he went to the doctor, she joked, “Why do you come here?” He replied, “I can’t write a prescription”.

Products to help consumers take charge of their health are everywhere at this trade show. National Pharma’s Naramin (diphenhydramine) in pre-filled single-dose “whistle” dispensers; TempTraq (Blue Spark Technologies), a single-use, wireless, wearable thermometer patch for kids; and Go Drive with Energy! (Fusion Biotech) dietary supplement specifically formulated for drowsy drivers, are among the many new products promoted.

NEW_GoDrive-20ctThese products are not exactly the game-changers industry might expect from an Rx-to-OTC switch, for example. However, they are true OTCs in the sense that they solve real problems with practical applications for self-treatment. Naramin allergy treatments are fun and portable for on-the-go families; TempTraq makes temperature monitoring easier for parents, and Go Drive with Energy! targets tired drivers with a unique product. Maybe they will have a Go Write with Energy! launch next year for journalists worn out from hours of walking the show floor.

OTC INSIGHT North America Blog: Canada Unveils New OTC Regulations

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In June 2014, Federal Health Minister, Rona Ambrose, announced her intention to create a new set of regulations for OTC products. Now the Minister has released the framework for moving OTCs and disinfectants out of the regulations covering prescription drugs where these products currently reside.

The proposals are wide-ranging and designed to give the government more flexible tools to manage the licensing of products intended for self-care. New tools have been undergoing pilot testing and the results were positive to the extent that the new rules will allow the implementation of some key market access approaches. This would include the adoption of monographs, which could be used to grant a product licence when a manufacturer attests to those standards. The monographs would be incorporated into regulations by reference, making then easier to adapt to changes as needed.

There will be five pathways to market authorisation. Including the compendial approach described above, there will be a stream for non-compendial submissions (ingredients that are not found in the monographs), administrative changes (e.g. manufacturer’s name change), prescription drug status switch (removal of an ingredient from the prescription drug list) and innovative non-prescription drug filings (e.g. novel ingredients and perhaps some types of switches).

The proposals also make reference to incentives for innovation and data protection but fail to provide much detail on what this would look like. However, it does appear that there is an intention to encourage switch through some form of market incentive.

Some things won’t change much. The good manufacturing practice rules will stay largely as they are. This will facilitate the use of mutual recognition agreements for import and export that have been developed over the past several years. Evidence for safety, quality and efficacy will remain and the evaluation process will be driven by a relative risk assessment and mitigation approach.

Some aspects of the proposal may have broader implications. For example, there is a suggestion to remove the prohibition on sampling for OTCs and allow sampling under prescription conditions. Since natural health products regulations are not in the scope of this project, the sampling prohibition would continue to apply to natural health products. While natural health products companies do sample and this prohibition isn’t generally enforced by Health Canada’s Inspectorate, there could be some noise about a level playing field on this matter.

There are numerous Easter eggs in these proposals and they will become more apparent as the consultations evolve.

For updates on this story, make sure you subscribe to OTC.NewDirections. There will also be in-depth analysis of these regulations in the upcoming December issue of OTC INSIGHT North America.