Bristol-Myers Squibb said it will ask the FDA to approve the sale of Pravachol without a prescription in its bid to become first to sell an over the counter cholesterol lowering drug in the U.S.
Currently Pravachol has sales of around $2.5 billion a year, but those numbers are expected to sharply drop once the drug loses patent exclusivity in 2006 and cheaper generics enter the market.
In recent years, the FDA has turned down similar requests to sell other statin drugs without a prescription arguing that self-diagnosis of high cholesterol is difficult and that it remains unclear whether low dose OTC versions of the drugs would produce health benefits.
Those attitudes may be changing, however, after Britain approved Merck's Zocor for sale without a prescription in that country, earlier this year and worldwide regulators come under pressure to make more medicines available over the counter to fight against runaway healthcare costs.
BMS also said that it has entered into an agreement with Bayer HealthCare for Bayer's Consumer Care Division to handle OTC sales and marketing for Pravachol in the United States, should the FDA approve OTC use of the drug. BMS said Bayer was selected given its experience in the cardiovascular category and the position it has achieved in the marketing of the Bayer Aspirin brand.