Pharma company seeks over-the-counter Plan B access for minors

———- Forwarded message ———-
From: michelle joseph
Date: Fri, Feb 18, 2011 at 10:52 AM
Subject: Pharma company seeks over-the-counter Plan B access for minors

Girls of any age could obtain over the counter access to the Plan B morning
after pill, if a request filed by Teva Pharmaceuticals with the Food and
Drug Administration (FDA) is approved.

BY Christine Dhanagom

WASHINGTON, D.C., February 17, 2011 ( – Girls of any age
could obtain the Plan B morning after pill without a prescription, if a
request filed by Teva Pharmaceuticals with the Food and Drug Administration
(FDA) is approved.

Teva manufactures Plan B One-Step, a form of the drug that the company
claims will prevent pregnancy with a single pill if taken within 72 hours of

Pro-life opponents of the pill have long pointed out that, like other forms
of emergency contraception, Plan B can also act as an abortificient by
preventing a fertilized ovum from implanting in the uterus.

“Plan B One-Step works like any other abortifacient drug: It can alter . .
. the lining (endometrium) of the mother’s uterus so that the newly-formed
baby cannot implant and thus dies,” aid Marie Hahnenberg, director of
American Life League’s The Pill Kills project. “Plan B One-Step’s
product information itself states, ‘It may inhibit implantation.’ Women
should not allow themselves to be misled by sales representatives for Plan B
and Plan B One-Step, who claim that these products will not terminate an
existing pregnancy.”

Plan B is currently available over the counter to women over the age of 17,
but requires a prescription for those under the minimum age.

The company’s request is the latest development in the drug’s embattled
history since it was first made available by prescription in 1999.

In response to a lawsuit filed by the Center for Reproductive Rights, the
FDA in 2006 made the pill available over the counter to women 18 years of
age and older.

In March of 2009, a U.S. District Judge ruled that the FDA’s continued
restrictions on the pill were in “bad faith and in response to political
pressure.” The Agency was ordered to lower the age of over the counter
access to 17, and to reconsider granting full over-the-counter status.

Last November, the Center for Reproductive Rights (CRR) filed a motion for
contempt against the FDA, arguing that the agency had failed to comply with
the court’s order to reconsider free access to the drug.

Advocates of the pill have expressed hope that Teva’s recent application
could provide additional leverage to their efforts.

“The FDA has had enough evidence before it to make a decision . . . since
before the lawsuit started.  There was no need to wait for another
application,” Ian Vandewalker, a CRR legal fellow, wrote in a blog post
Monday. “The Teva application may get the ball rolling on a final decision
on Plan B, which will likely result in increased access for teens.”

Opponents, however, are raising concerns about the effect that increased
access will have on the health and well-being of minors.

“Plan B has been an utter failure at reducing abortions or pregnancies,
which was the main argument for making it available over the counter. This
senseless obsession with giving it to minors without doctor’s oversight is
not in the best interest of children,” Wendy Wright, President of
Concerned Women for America, told LifeSiteNews in an interview.

“There’s a good reason why even the birth control pill requires a
prescription, which is an even lower dose of the drug. . . . It offers an
opportunity for the woman to get a check up, for the doctor to talk to her
and check her for sexually transmitted diseases and find out if she is being

Wright also pointed out that several studies have indicated that many women
now rely on Plan B as a substitute for normal methods of birth control,
despite the lack of information about the effects of regular use.

“They haven’t done the tests,” said Wright, “They’re not going to
do the tests because they don’t want to find out. That’s why it is
incredibly irresponsible for the FDA to continue approving these kinds of

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