"We're committed to Rogaine," a company spokesman said, noting Upjohn is working on a more potent version of the product, expected to go to the FDA for approval later this year.
Even if OTC approval can't be won, Rogaine will continue to get marketing support, including a 30-minute infomercial now before the FDA, the company said.
Upjohn has supported Rogaine with an estimated $20 million marketing campaign that skewed younger and more toward women early this year. TV, print and direct marketing, using a toll-free number in ads, are included. Kobs & Draft, New York, is the agency.
Still, the future of the product has to be in question if final FDA approval isn't won.
Sales of Rogaine, introduced in the late 1980s, slid 31% to $110 million last year. Part of that was due to special retailer deals and discounting that led to drugstores hoarding the product in 1992 and buying little in the beginning of 1993; sales for the first two quarters of 1994 have been "on an even keel" at about $25 million per quarter, the spokesman said.
The FDA panel questioned how well Rogaine works and how big a healthcare concern baldness is.
Rogaine "has only a modest effect even in those instances when it works," said an FDA spokesman. "There also was a concern about self-diagnosis; everyone knows if they are losing hair, but they don't know if it is the result of pattern baldness or of a skin condition or, among women, more serious problems."
That may also be true of other OTC drugs, such as analgesics. But because they are usually not used for long periods of time, there aren't the same dangers, said the spokesman.
Most doctors keep patients on Rogaine for a full year to see if the product works, and even if it does, usage must be continuous to maintain hair regrowth. According to Upjohn, about two-thirds of women and one in three men respond to Rogaine.
"It's a little like nicotine patches," said Kate Griffe, manager of the pharmaceutical group at consultancy Kline & Co., Fairfield, N.J. "It's a long-term therapy with a lot of failure and a lot of repeat tries. Consumers want faster results."
Also last week, the FDA panel recommended against an OTC switch for SmithKline Beecham's Tagamet because of the dangers of interaction with other drugs.
However, the company noted the FDA supported the product's efficacy and is optimistic about eventual approval. As an OTC product, the ulcer drug would be recommended for heartburn.