OTC Morning After To Be Decided By Sept. 1

    July 18, 2005
    WebProNews Staff

After a politically charged back-and-forth, the US Food and Drug Administration sent a letter to the Senate stating that a decision on whether to allow the morning-after pill to be sold over the counter will be reached by the first of September.

Also known as the Plan B emergency contraceptive pill, the decision to make a decision about non-prescription status was presented to the Senate in letterform by Health and Human Services Secretary Michael O. Leavitt.

The formal revelation was greeted with praise from Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.). The two Senators agreed to lift a “hold” on the nomination of Lester Crawford, President Bush’s choice to be the next permanent FDA commissioner.

“We have been clear all along that our hold on this nomination is about one thing only: the FDA’s failure to provide an answer on Plan B,” the two senators said. “After more than two years of waiting, American consumers and American women will finally get an answer.”

Available with a prescription to women in the US since 1999, a decision in favor of Plan B for sale over the counter to any woman 16 years of age or older would delight and anger many.

The drug, available without a prescription in Britain since 2001, is thought to work by preventing ovulation and fertilization and may inhibit implantation of a fertilized egg into the lining of the uterus. Effective up to five days after intercourse, the emergency contraception is most effective when used within 72 hours.

Requiring a prescription is thought not only to lessen the chances of a woman acquiring the drug in time, but also to lessen the chance she will seek to prevent an unwanted pregnancy in the first place for fear of embarrassment or lack of money for a doctor’s visit.

The FDA has not acted on the application by Plan B maker Barr Laboratories since its submission in July 2004. The application stated that the drug was safe for women as young as 16 without a prescription.

To pressure a decision, Clinton and Murray blocked Crawford’s nomination. Leavitt indicated a concession to produce a decision in a letter to the Senate.

“This decision rests solely with the FDA and must be made according to the scientific evidence and FDA’s authority,” Leavitt wrote. “However, I have spoken with the FDA, and based on the feedback I have received, the FDA will act on this application by Sept. 1, 2005.”

The prospect of an easily available morning-after pill doesn’t sit well with more conservative constituents. Opponents of the drug, in addition to a belief that it is a form of abortion, say its approval would encourage teen promiscuity and discourage condom use. Pharmacists in several states have refused to fill prescriptions for the pill and these same ones have vowed not to carry it on the shelves if approved for OTC.

Earlier this month, a British study indicated that making the morning-after pill available over the counter had no impact on behavior.

“Making emergency hormonal contraception available over the counter does not seem to have led to an increase in its use, to an increase in unprotected sex, or to a decrease in the use of more reliable methods of contraception,” wrote the researchers of the study.

As might be expected, single and younger women were three times as likely to use the pill, but over half, 53%, were over the age of 25.