YOU ARE HERE: LAT HomeCollections

Drug Firms Jumping Over the Counter : Pharmaceuticals: By switching from prescription formulas with FDA approval, they hope to boost sales, protect their turf.


To get Rogaine, the only federally approved drug for treating hair loss, a person must see a doctor for a prescription. But many people apparently think that visiting their doctor about a problem that is usually more cosmetic than medical is too much trouble--or maybe a little too embarrassing.

"You usually go to a doctor because you're sick; you usually don't go just to discuss hair loss," said Jeff Palmer, a spokesman for Upjohn Corp., which manufactures Rogaine.

Upjohn hopes to remedy that problem. It is seeking federal approval to market an over-the-counter version of Rogaine that would cost less and, the company hopes, encourage more people to give the treatment a try.

Upjohn is one of a growing number of drug makers that have been switching more of their prescription drugs to over-the-counter status in hopes of boosting sales. While some people may be bewildered by the growing array of remedies on drugstore and supermarket shelves--and by the potential health risks--the development is mostly good news for consumers because it makes these drugs more widely available at a lower cost, experts say.

"I think it's a very good trend," said Joel Hay, a health economist at USC's School of Pharmacy.

Next week, a Food and Drug Administration advisory panel will consider requests from drug makers to approve three high-profile products for sale over-the-counter. Besides Upjohn's request for Rogaine, Merck is seeking approval for a lower-dose version of its popular anti-ulcer drug Pepcid. And SmithKline hopes to gain approval for a non-prescription version of Tagamet, one of the world's best-selling drugs.

If the panel recommends the switch, as analysts expect, the full FDA is likely to follow suit and grant formal approval to the products. However, the drugs are not expected to be available on store shelves until sometime next year.

For Kalamazoo, Mich.-based Upjohn, winning approval for a non-prescription version of Rogaine--the only prescription treatment for hair loss--is crucial to boosting lackluster sales of the drug. Worldwide sales of Rogaine were $110 million last year, down slightly from the previous year.

Analysts say sales of Rogaine, introduced in 1988, have suffered because the drug doesn't work as well as many consumers hoped.

"We're hoping the switch to OTC would at least stabilize sales of the product, which are declining as the prospective audience has become increasingly disenchanted," said Steven Gerber, analyst at Oppenheimer & Co. in Los Angeles.

(Upjohn officials cite results from medical studies that show that after four months, 26% of patients using Rogaine report "moderate to dense" hair regrowth.)

Analysts say Rogaine is a good example of a drug that could benefit greatly from being available without a prescription. Rogaine is relatively pricey, at about $55 to $60 a month--or $660 to $700 a year.

Most health insurance plans don't reimburse patients for Rogaine because it is considered a cosmetic treatment. And because a patient now must go to his doctor to get a prescription for Rogaine, there are costs, such as insurance co-payments, that add to the expense and inconvenience.

Upjohn believes that converting Rogaine to over-the-counter status will broaden the market because consumers will be able to buy it more easily. The company also plans to cut the price, but it isn't saying yet by how much, Palmer said.

Converting prescription medications to OTC use has boosted sales in the past. When Schering-Plough's Gyne-Lotrimin and Johnson & Johnson's Monistat--both anti-fungal products used to treat vaginal yeast infections--were switched in 1990, sales more than doubled in two years.

With Tagamet and Pepcid, the manufacturers hope to bring out lower-strength versions that would be used for "sour stomach" and heartburn rather than ulcers. The U.S. patent protection on SmithKline's Tagamet expired in May, and the brand-name product is already facing tough competition from lower-cost generic versions. Bringing out an OTC version is one way for SmithKline to slow the erosion in sales of the product.

Health experts advise consumers to use OTC medications with caution.

"Most of the time, people don't realize that OTC products can interact with each other or a prescription drug," said Melanie Privette, a spokeswoman for the American Pharmaceutical Assn., a pharmacists trade group. "Just because OTC products are often not as powerful, they still can cause very strong side effects."

To be on the safe side, Privette and others advise consumers to read product labels carefully and discuss proper use of medications with their pharmacists.

Los Angeles Times Articles