Plan B, also known as the morning-after pill, is on its way to
being sold without prescription to women 18 and older.
The U.S. Food and Drug Administration’s decision last
Thursday to allow over-the-counter sale of Plan B has spurred
opposition from some who say the easier access to the pill will
promote unprotected sexual activity, and applause from others who
say the new decision could lead to fewer unwanted pregnancies,
especially among young women.
The FDA’s decision is not the final step in making Plan B
available over the counter. Plan B has been available with a
prescription since 1999.
“There has to have a system in place to ensure that the
sale only occurs to those eligible. … Anyone under age 18 will
have to have a prescription, and a system is needed to monitor the
program,” said Steven Kozel, pharmacy manager at the Arthur
Ashe Student Health and Wellness Center at UCLA.
Plan B consists of two hormonal pills used to prevent pregnancy
by preventing ovulation, fertilization or implantation of a
fertilized ovum. If taken within 72 hours of having unprotected
sex, Plan B can be up to 89 percent effective.
“Wider access is a step in the right direction,”
said Ram Parvataneni, a UCLA assistant professor of obstetrics and
gynecology. “(Selling Plan B over the counter) has potential
to significantly reduce unwanted pregnancies.”
Plan B works differently from the abortion pill, RU-486, which
terminates an existing pregnancy and is only administered with a
prescription, Kozel said.
In the Aug. 24 approval letter, Dr. Steven Galson, director of
the Center for Drug Evaluation and Research, outlined tasks that
the company marketing Plan B, Duramed, agreed upon. This included
establishing programs to enforce the age-based restriction.
Individuals younger than 18 years old must have a prescription to
obtain Plan B.
In the Convenient Access, Responsible Education program,
Duramed, a subsidiary of Barr Pharmaceuticals, will provide
consumers and health care professionals with labeling and education
about the appropriate use of prescription and over-the-counter Plan
B.
Among other duties, Duramed will also work to ensure that
distribution of Plan B will only be through licensed drug
wholesalers, retail operations with pharmacy services and clinics
with licensed health care practitioners. Plan B will not be sold
through convenience stores or other retail outlets in an effort to
control its distribution and prevent its sale to younger women
without a prescription.
“Leveraging well-established state and private-sector
infrastructures will allow for comprehensive and effective
enforcement of the age-based restrictions. … This approach should
help ensure safe and effective use of this product,” wrote
Andrew C. Von Eschenbach, acting commissioner of the FDA in a
memorandum on Aug. 23.
There have been concerns about widening access to the
morning-after pill because some believe it may cause women to be
less vigilant about using condoms, leading to an increase in the
incidence of sexually transmitted diseases.
But Parvataneni said studies with more than 2,000 participants
have shown that the availability of Plan B had no impact on the use
of contraception or on sexual behavior.
Other people remain unsure of whether it will have a big impact
on people’s behavior.
“A lot of it depends on how much it costs as an
over-the-counter product, and how well educated the public is about
it,” Kozel said.
Nevertheless, wider access will save consumers time crucially
needed to prevent pregnancy.
“Selling Plan B over the counter can be really convenient
because you can avoid an unnecessary wait,” said Jennifer Du,
a UCLA psychology and political science student who graduated this
year.
“Waits are expected at a federally funded clinic, which
can put the girl in an unnecessary position, waiting up to three
hours to get the prescription,” Du said. “Making it
more convenient is helpful because females who seek out the
morning-after pill are in a position where they are very stressed
out, worried, anxious, and time is an issue.”