Barr Pharmaceuticals received some very good news yesterday, as US regulators eased regulations governing the use of its morning after pill, Plan B, by allowing women over 18 to buy it over the counter.
The decision marks the end of the company’s long fight for approval to sell Plan B (levonorgestrel) without a prescription and without an age restriction. But regulators did insist that those aged 17 and under still require a prescription to get access to the drug.
“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,” commented Bruce Downey, Barr’s chairman.
Non-prescription sales of the drug are scheduled to begin by the end of the year, but only in pharmacies to help keep some control over the age restriction. In line with this, the company has agreed to keep a check on whether the age limit is being enforced, and says it is planning a
national awareness campaign to help educate women about this form of contraception.
The drug's switch to over-the-counter could double its sales to $80 million-$100 million over the next three years, Friedman Billings Ramsey analyst Robert Uhl told the Associated Press, but he said that they will still only represent a reltively small amount of Barr's overall revenue.
Plan B can cut the risk of getting pregnant by 89% for up to 72 hours after unprotected sex, according to the company. But, as the drug is most effective when taken within 24 hours, both Barr and health officials argue that eradicating the need for a prescription, and thereby quickening access to Plan B, can reduce the amount of unwanted pregnancies
And US consumer advocacy group Pubic Citizen has slammed regulators for the delay in approving the drug's switch to OTC. "The Food and Drug Administration's inexcusable delay in approving over-the-counter sales of Plan B, the “morning after” pill, has caused more damage to its reputation and public confidence in the agency," it said in a statement. "The delay was caused by political pressure from social conservatives and the religious right that trumped scientific judgment, inevitably resulting in many abortions in women who otherwise would not have become pregnant."
But there are also those who are strongly opposed to the move, on grounds that easy availability of the morning after pill may lead to an increase in sexually transmitted diseases.