FDA sanctions ‘morning after pill’ to be sold over the counter

New York, November 28: The emergency ‘morning after’ Plan B contraceptive pill now has over-the-counter status. In a landmark decision the Food and Drug Administration (FDA) sanctioned that the drug be sold to adults without prescription.

Sex is not always planned or prepared for. Emergency contraception gives women the right over their sexuality and fertility. In 2006, the FDA had approved ‘behind the counter’ sale for Plan B, in which younger people required a prescription from a doctor.
The single dose pill contains the hormone progestin, the ingredient of regular birth control. It is quite effective in preventing pregnancy if taken within 72 hours of unprotected sex. The work of the pill is primarily preventing the ovaries from releasing an egg or delaying its release. It does not affect an existing pregnancy unlike abortion pill RU-146. The side effects are normally nausea and vomiting.

Dr Rebekah E Gee of the University of Pennsylvania, School of Medicine in Philadelphia, lead researcher on the study said “The sooner you take it the more effective it is which is why availability is so important.”

To gauge the effectiveness of the rule on its accessibility, Gee and her team carried out a survey of the pharmacies in Atlanta, Boston and Philadelphia. It was conducted in two rounds in 2005 and 2007 and included 1087 and 795 pharmacies respectively.

In the first round in 2005, Gee found that 23 percent of the pharmacies were unable to dispense Plan B within 24 hours. In 2007 only 8 percent were able to do so.

The State of Atlanta allows a chemist to sell emergency contraception at his discretion in keeping with his moral or religious beliefs. In Atlanta, the figures showed the rate of refusal was 9 percent in 2005 which fell to 2 percent in 2007. The rate of pharmacies unable to dispense the drug within 24 hours fell from 35 percent to 4 percent.

In Philadelphia where no such rule exists, the pharmacies unable to allot the contraceptive dropped from 23 percent in 2005 to 10 percent in 2007. The rate of refusal was 3 percent in 2005 and 4 percent in 2007.

Boston, which requires the pharmacies to stock all common medicines showed a low rate in the two rounds conducted. There was a fall in both dispensing and refusal of Plan B.

There is a strong possibility of pharmacies being adamant against over-the- counter sales because they fear losing consultation fees. The product may not be for everyone, but if you need it absolutely it should be available,” said a spokesperson of Barr Pharmaceuticals Inc. marketing the pill.

Public health advocacy groups claimed that requiring a prescription can make the drug difficult to obtain within the critical period. Women just do not want to discuss their personal lives with a pharmacist. They want to take charge of their lives and should be able to procure the pill when the need arises, since it is safe and effective. It is an emergency drug to prevent an unwanted pregnancy.

Some are skeptical that this may give rise to promiscuity in the young. The debate is much broader than teen age pregnancies. The decision to make the ‘morning after pill’ easy to obtain is part of a wider sexual health strategy. Gee feels “There is no evidence that use of Plan B leads to more intercourse or riskier behavior, even though some of its opponents have claimed that. The data definitely shows that is not true.”

The United States has the highest rate of pregnancies, with nearly one in three women going in for an abortion. Gee admits that Plan B is not a replacement for contraception nor does it decrease the rate of unplanned pregnancies. Nevertheless, her team felt that “Only through increased access to more effective methods of contraception and by empowering women to be educated about their reproductive health will we see a likely change in unintended pregnancy rates.”