Marketers prepare for more over-counter drugs

In keeping with a worldwide trend in health care regulations, Health & Welfare Canada is moving to more rapidly shift commonly prescribed pharmaceutical products from prescription-only to over-the-counter status.The development is being closely monitored by pharmaceutical manufacturers, which must be prepared...

In keeping with a worldwide trend in health care regulations, Health & Welfare Canada is moving to more rapidly shift commonly prescribed pharmaceutical products from prescription-only to over-the-counter status.

The development is being closely monitored by pharmaceutical manufacturers, which must be prepared to shift their brand marketing from doctor- and pharmacy-focussed to consumer-focussed.

Mary Carman, director of the bureau for non-prescription drugs, says as many as eight or nine ingredients are being looked at, more than double the number the bureau has typically had under review at any given time.

Carman says it is possible three will be approved for rescheduling before the end of the year.

First up for approval will be several closely related vaginal fungicides, perhaps as early as the second quarter, she says.

Prescription vaginal fungicides represent a $24-million market in Canada.

The leading brands in the category are Ortho Pharmaceutical’s Monistat, based on a drug called miconazole, and Miles Canada’s Canesten, based on a drug called clotrimazole.

Another likely candidate for rescheduling by Health & Welfare in 1994 is the anti-inflammatory ibuprofen in combination with other ingredients so that it becomes effective as a cough and cold treatment.

(Ibuprofen is already available over-the-counter as a single-ingredient product in low-strength doses. Advil, made by Whitehall-Robins, is one such brand.)

Perhaps the biggest category of drugs under review are the ulcer remedies known as H2-antagonists.

The four main brands in this multi-million-dollar category, which is in line to switch over in 1995, are Tagamet, made by Smithkline Beecham Pharmaceuticals, Zantac, made by Glaxo Canada, Losec, made by Astra Pharmaceuticals Canada, and Pepcid, made by Merck Frosst Canada.

Vaginal fungicides such as Monistat and Canesten have been sold over-the-counter in the u.s. since 1991.

Walter Masanic, head of public relations with Ortho, says his firm is in the process of drawing up a consumer marketing plan for Monistat, but declines for competitive reasons to reveal details.

Peter Sewell, senior product manager with Miles, is equally reluctant to discuss his company’s plans for Canesten, admitting only that he is ‘working on a strategy.’

Typically, Health & Welfare places a prescription drug under review for a possible switch to over-the-counter status only after it has been requested to do so by a pharmaceutical manufacturer.

Carman says review requests are more frequent now than in the past because manufacturers are worried about the trend by cost-cutting provincial governments to remove older generation products from their free medicare plans.

By shifting their brands to over-the-counter status, manufacturers can keep them alive and, through savvy marketing, even build sales volume.

As well, when prescription drugs reach the end of their patent protection, they invariably face stiff competition from low-priced generic brands.

In switching their products to over-the-counter status, research-based manufacturers gain an opportunity to take on their imitators in the wide-open consumer marketplace where brand image matters.

For their part, federal drug regulators have taken steps, such as streamlining the application process and accepting research data collected in other countries, to make it easier for manufacturers to get switches approved.

Last October, Frosst Consumer Healthcare Products, Merck Frosst’s sister firm responsible for consumer products, took a step that will likely become increasingly common as greater numbers of drugs come up for review.

It hired a Toronto public relations firm, GCI Communications, a division of Grey Advertising, to help it convince drug regulators that H2-antagonists were deserving of reclassification.

Gary Lyon, director and general manager of Frosst Consumer Healthcare, says he hired the shop because to effectively manage the switch of Frosst’s Pepcid brand he needs to communicate with several different stakeholder audiences, including medical practitioners, the pharmacy establishment, and, ultimately, the regulators.