Word is starting to spread on media sites like Time and the Washington Post that the US Food and Drug Administration intends to make the emergency contraception pill, Plan B, available on drugstore shelves and without any age restrictions for purchase. That means it may soon be as easy to buy as aspirin when the FDA issues its decision, which is expected tomorrow.
Plan B has been available over the counter for the past five years -- but hidden behind the pharmacy counter and available for purchase only by those 17 years of age and older.
Women’s health advocates have complained that this has made it difficult for teens and young adults to get access when, say, that condom breaks and the pharmacy is closed.
Plan B, which contains a high dose of synthetic progesterone, can prevent pregnancy if taken within 72 hours of unprotected sex and sells for about $40.
The FDA dragged its feet for years on making Plan B available over-the-counter and then was criticized by a federal judge -- who ruled in a 2009 lawsuit brought by reproductive rights activists -- for allowing it to be sold without a prescription only to those over 18. (Plan B is available by prescription without any age restriction.)
The judge ruled that the FDA had to make the product immediately available to 17-year-olds and instructed the agency to review whether to make it available to women and girls of all ages.
Teva pharmaceuticals, the drug’s manufacturer, filed an application with the FDA in February seeking full over-the-counter approval for the drug, which would remove the age restriction, and the FDA has until tomorrow to issue its decision on that request.
My sources within the pharmaceutical industry told me last week that they expected the FDA to lift the age limits on Plan B and place it directly on drugstore shelves. (The FDA declined to comment.) While safe enough to be sold over-the-counter, the pill does have side effects including nausea, abdominal pain, headache, dizziness, and breast tenderness.
And I wonder if young teenage girls will be savvy users of the product, which shouldn’t be used as regular birth control and is useless if taken more than three days after unprotected sex. These 13- and 14-year-olds also need to understand that if their period comes more than a week late, they could still be pregnant, even if they took the pill as directed. And, if they have severe abdominal pain along with a missed period, they should seek immediate medical attention because they could have an ectopic pregnancy.
If Plan B does become more readily available, I’m hoping the manufacturer gives girls a thorough education on the right way to use it.Deborah Kotz can be reached at firstname.lastname@example.org. Follow her on Twitter @debkotz2.