OTC DRUG SALES SURGE DEPENDS ON FDA ACTION

JOHN KAROLEFSKI

COLORADO SPRINGS. Colo. -- Move over, Aleve! You're about to get plenty of company on the retail shelf. Sales of over-the-counter drugs will grow steadily -- and perhaps dramatically -- over the next five years, especially if some governmental hurdles can be overcome. The key to the growth of these brands will be making it easier for the Food and Drug Administration to approve the "switch" of prescription drugs to OTC status.

That was the consensus of several officials of the Nonprescription Drug Manufacturers Association who spoke here a few weeks ago at NDMA's 115th annual meeting "The self-medication market is poised for tremendous growth worldwide as OTCs play an increasingly important role in helping consumers assume more control over their health care needs, and helping societies in general reduce health care costs," said Thomas Laughlin, senior vice president, worldwide, and general manager of U.S. Consumer Healthcare, Pharmacia & Upjohn Inc., Kalamazoo, Mich.

Laughlin, this year's chairman of NDMA, addressed a VIP audience that included former New York Governor Mario Cuomo, former Secretary of Education William Bennett, and the presidents of such companies as Johnson & Johnson/Merck Consumer Pharmaceuticals, McNeil Consumer Products, Schering-Plough Healthcare Products and Warner Wellcome Consumer Healthcare. More than 300 executives attended the meeting.

Laughlin said the global OTC market is estimated at about $40 billion, with the United States accounting

for $13 billion or 33%. With the increasing rate of prescription-to-OTC switches and more consumer interest in self-care, it's expected that the U.S. market will grow by at least 16% over the next five years, exceeding $15 billion by the year 2000, he said. "There are some who predict this number could be well north of $20 billion as we start the next century, particularly if the recent pace of prescription-OTC switches continues," said Laughlin. Typical of the effect of switches is the success of Aleve from Procter & Gamble. The brand of analgesic became a nonprescription drug in 1994 and immediately posted sales of $10 million in the first month in food and drug stores, according to Towne-Oller & Associates, New York.

"I was advised by a senior medical reviewer at FDA that the agency was looking at around 100 switch and switch-related supplemental petitions. So expect to see a flurry of new OTC products in the United States over the next five years," said Laughlin. But there could be trouble in paradise in the form of the Food and Drug Administration, the agency that must approve the switch of drugs from prescription-to-OTC status. "FDA is far from perfect," said Laughlin. "We think OTC decisions can be made in less time, with more consistency and with better feedback. And we're trying to work with FDA to achieve these goals." FDA created an OTC Office of Drug Evaluation in November 1991, which presided over and facilitated switches. But it was abolished last year as part of an internal reorganization. NDMA, in an effort spearheaded by its president, James Cope, is working to have the office reinstated. "The recent switches we've seen were because there was an office. The office has now been downgraded to a division. Now our member companies will be sending their applications to five different offices, who have basically prescription drug interests. So these OTCs will be of incidental concern to them," Cope told Brand Marketing in an interview following his talk here. "An office that focuses on self-care, thinking of people as consumers, not patients, thinking of what consumers are capable of doing in the way of self-care, who learn more about that, who can handle the applications and see to the care and feeding of them, will result in more switches, better switches, better self-care and a reduction in total health care costs," he said. "We need consistency. We need visibility. We need timeliness. We need people who develop the expertise to provide all that. Only an [OTC] office can do that," he said. NDMA last month urged Congress to support legislation that would help facilitate the approval and marketing of new OTC products. NDMA would like to see provisions that would do three things: (1) create an OTC Office in FDA's Center for Drug Evaluation and Research, (2) allow drug review by independent organizations, including accredited foreign regulatory authorities, and (3) establish one national system of regulation for OTC medicines.