The maker of the Plan B morning-after emergency contraceptive pill is gearing up for another round with a FDA experts panel of to examine the ongoing question: should this pill should be sold to girls under the age of 17 without a prescription?
FDA Questions Whether Plan B Pill Should Be Made Available to Younger Women and GirlsThe Plan B pill is currently only available without prescription to purchasers 17 and older.
As not everyone knows, women cannot become pregnant at just any time of month. There is a one- to five-day window in the middle of the menstrual period when the ovaries release one or more eggs. If the egg is not fertilized within a day or two, it dies, and the woman is not fertile again until she ovulates in her next monthly menstrual cycle.
There is no way a woman can know with 100 per cent accuracy, however, that she has ovulated on time. That is why various kinds of emergency contraception have been around for almost 30 years, protecting women against unplanned pregnancy after unprotected sexual intercourse or contraceptive failure (for example, a broken condom).
The Plan B emergency contraceptive, used in the United States, Canada, and New Zealand, is a high dose of a hormone called progestin. It works up if taken up to 72 hours after intercourse by stopping implantation of the fertilized egg in the uterus, but it will not abort an embryo that has already been implanted. This is the major difference between Plan B and a different kind of emergency contraceptive called RU-486. Plan B, however, has fewer side effects (mainly nausea and vomiting) than other emergency contraceptives.
Why wouldn't this product be given to users under the age of 17?
Wider Availability of Plan B Would Lead to Greater Promiscuity, Conservative Groups FearThe controversy over Plan B dates back to 2001, when then-President George W. Bush instructed the FDA to limit access to the drug. Conservative groups then and now were concerned that making the drug available to females younger than 17 without a doctor's note would encourage promiscuity. Teen pregnancy rates during the Bush administration, it should be noted, increased significantly over those during the previous administration.
The matter remained stalled until the end of 2008, when Planned Parenthood sued the FDA to force it to consider making all emergency contraceptives more widely available. By this time other, generic products began competing with Plan B. Both Plan B and the competing products require taking two pills. To retain its share of the market, Teva, the company that makes the pill, came out with Plan B One-Step, which only requires taking one pill. In the meantime, Teva, understandably, believes it can sell more pills if the product is available to all females without a doctor's prescription. The company argues that since it developed the original product, it deserves the right to sell its new formulation to as many users as possible.
The decision will be made after consideration of actual use of emergency contraception by girls aged 11 to 16 in the United States. Approval or rejection of prescription-free sales of Plan B One-Step to females under 17 is expected by the end of the year. Nearly one in ten women in the United States has used emergency contraception, and potentially hundreds of thousands of girls will also use the product.