July 31, 2006 -- FDA Says It's Working on OTC Status for Plan B

In a surprise announcement just hours before the nominee to head the federal Food and Drug Administration (FDA) was scheduled to appear before a Senate committee to answer questions about delays in over-the-counter approval for emergency contraception known as Plan B, the FDA says it is "proceeding to work with Duramed, a subsidiary of Barr Pharmaceuticals, to resolve the remaining policy issues associated with the marketing of Plan B as an over-the-counter option." In a letter to Duramed, the FDA said it will discuss moving Plan B from prescription status to over-the-counter status for women 18 and older. Over-the-counter status for Plan B has been in limbo since the FDA in 2003 rejected the recommendation of an advisory panel that the emergency contraceptive be made available without a prescription. The agency explained that it was concerned that younger teenagers would not use the pills properly unless they had a doctor’s guidance. Today’s announcement said the FDA wants to meet with Duramed within seven days to iron out new steps the company must take, but set no deadline on when the FDA might approve over-the-counter sales.