Emergency Contraception to Go Over-the-Counter?
Decision on Plan B Without a Prescription Expected by September
WebMD News Archive
July 18, 2005 -- The FDA will decide by the end of the summer whether to
allow the morning-after pill to be sold over the counter in U.S.
Health and Human Services Secretary Michael O. Leavitt stated in a letter
released over the weekend that the agency will rule on nonprescription status
for the Plan B emergency contraceptive pill by Sept. 1.
In response, two Democratic senators agreed to remove a block on the
nomination of Lester Crawford, President Bush's pick to be the next permanent
Plan B has been available to American women with a prescription since
Concerns Over Sex Habits
Plan B is thought to prevent pregnancy principally by preventing ovulation
or fertilization (by either altering transport of sperm or the egg). In
addition, Plan B may inhibit implantation into the lining of the uterus. It is
not effective once the process of implantation has begun.
Plan B is effective up to five days after unprotected sex, but it is most
effective when used within 72 hours.
The FDA has yet to act on a year-old application from Plan B manufacturer
Barr Laboratories to allow sales of the drug to women 16 years of age and
older. The delay spurred complaints from family planning supporters that the
Bush administration was politicizing approval of the controversial drug, which
some feel may encourage teen promiscuity or discourage condom use.
A U.K. study released earlier this month showed making emergency
"morning after" contraceptive pills available over the counter had not changed rates of contraceptive use or
unprotected sex. Emergency contraception has been available without
a prescription in the U.K. since 2001.
In late 2003, an FDA advisory panel recommended 23-4 that a similar
application from Barr be approved. But the agency rejected the bid, saying that
the company had not proved that Plan B is safe for women under 16. The company
submitted a new application in July 2004.
FDA Weighing Scientific Evidence
"This decision rests solely with the FDA and must be made according to
the scientific evidence and FDA's authority," Leavitt wrote in his letter
to senators. "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,
Leavitt's letter prompted Sens. Patty Murray (D-Wash.) and Hillary Rodham
Clinton (D-N.Y.) to lift the "hold" on Crawford's nomination, which
they enforced in June in an effort to force the FDA to issue a decision on Plan
"After more than two years of waiting, American consumers and American
women will finally get an answer," the senators noted in a joint
If the FDA backs over-the-counter status for the drug, women 16 and older
with proof of age will be able to buy it without a prescription.
Small but vocal groups of pharmacists in several states have refused to fill
Plan B prescriptions and have also vowed not carry the drug on shelves if it is
approved for nonprescription sales.