Barr’s Plan B gets OTC approval in US

Barr’s three year battle to sell the drug over-the-counter has caused considerable controversy in the US with some groups claiming that easier access to the drug would promote sexual promiscuity among teens, whilst the drug’s supporters felt that OTC access to the product would cut the rate of unwanted pregnancy and abortion.

Because Plan B will still remain a prescription product for women 17 and younger, it will be sold from behind the counter in pharmacies, and young women will be required to show proof of age when purchasing the product.

“While we still feel that Plan B should be available to a broader age group without a prescription, we are pleased that the Agency has determined that Plan B is safe and effective for use by those 18 years of age and older as an over-the-counter product,” said Bruce Downey, Barr’s chairman and CEO. “We believe making Plan B available without a prescription to those 18 and older will ensure that millions of women have more timely access to an emergency oral contraceptive following unprotected sexual intercourse or a contraceptive failure.”

Mr Downey went on to say that Barr would continue to work with the FDA to further lower the age limit on the product.

Taken within 72 hours of unprotected intercourse, Plan B has been shown to reduce the risk of pregnancy by 89% after a single act of unprotected sex. Effectiveness declines as the interval between intercourse and the start of treatment increases, with Plan B being more effective when taken in the first 24 hours after intercourse.