Stark, President of Morris County NOW, is quoted extensively in
Contraceptive generates controversy
Pharmacies and women-oriented organizations are voicing
contradictory opinions over the U.S. Food and Drug
Administration’s (FDA) ruling that girls 18 and older can now
buy emergency contraception pills over-the-counter, without a
CHRISTINA MUCCIOLO Staff Writer, Observer-Tribune, 09/07/2006
On Thursday, Aug. 24,
the FDA announced approval of Plan B, emergency contraception or
the morning after pill, as an over-the counter option for women
18 and older, but only with proof of age. The FDA said
Plan B is a method of preventing pregnancy after a contraceptive
fails or after unprotected sex. According to an FDA
statement, Plan B will remain available by prescription only to
women 17 and under. Plan B is administered in two pills
containing a higher dose (.75 mg in each pill) of Levonorgestrel,
an ingredient found in most prescription birth control pills.
If taken within 72 hours (three days) of unprotected sex, Plan B
can reduce the risk of pregnancy by 89 percent, according to the
Nonprescription sales of Plan B would begin at the end of the
year, and in the interim, Plan B will remain available as a
prescription product only, said Anna Manno, a spokesperson for
Barr Labratories of Woodcliff Lake, who manufactures Plan B.
“Plan B must be stored behind the counter as it remains a
prescription product for women 17 and younger,” Manno said.
“Pharmacists and their staff will need to be prepared to answer
questions at the point of purchase and to follow a protocol,
where appropriate, for asking customers to provide government
issued identification to verify they are 18 years of age or
As pharmacies prepare for their new stewardship role of
over-the-counter sale of emergency contraception, some area
pharmacists think Plan B should still require a prescription.
“I wouldn’t really be for it as over-the-counter,” said Ken
Hodge, pharmacist at Robinson’s Drugstore on Main Street in
He said he was not necessarily referring to the moral decision
for sale “but the possible side effects in some people and the
physical concerns of some people.
“It’s a personal choice,” he said, but in his professional
opinion, “It should be prescribed by a physician.”
The pharmacist at Mendham Apothecary in the Mendham Village
Shopping Center on Route 24 declined to comment.
Long Valley Pharmacy on Mill Road carries Plan B.
“We stock it, but I don’t think it’s a good idea to sell it
over-the-counter,” said owner Phil Crangelo.
“The problem with it is that young ladies are going to use it as
birth control,” Carangelo said, “I think this will lead to more
STD’s. (sexually transmitted disease)”
Chester Rite Aid Pharmacies located in the Chester Shopping Mall
on Main Street and The Chester CVS on 206 South, both carry Plan
Over-the-counter approval came after a long back and forth which
started in December 2003, when the FDA reviewed the application
which would allow the sale of Plan B without a prescription.
Later in May, the FDA issued a “not-approvable” letter for
over-the-counter sale to Barr Labs, on the grounds of
insufficient information on the use of Plan B by adolescents
younger than 16 without the intervention of a physician.
Although Barr originally submitted for Plan B to be an
over-the-counter product for girls 16 and older, in August 2005,
then-FDA Commissioner Lester M. Crawford, approved the
application, but only for women 17 and older.
The approval went to the state, but the path to approval was
stymied until earlier this month when the Center for Drug
Evaluation and Research (CDER) helped Barr negotiate how to
address the issues raised in a letter from FDA Commissioner, Dr.
Andrew von Eschenbach. Issues included restricting the
over-the-counter sales of Plan B to women 18 and older.
Although the FDA announced approval of over-the-counter sale of
Plan B shortly thereafter, the long and winding road is not
finished for some women-centered organizations, both liberal and
“It is irresponsible of the FDA to approve the sale of this
drug,” said Marie Tasy executive director for New Jersey Right
to Life in Cranford on Thursday, Aug. 17. “One of the
mechanisms (of the drug) is to prevent implantation of the newly
conceived human into the uterus, which is abortion.”
“Women are being deceived, they are being exploited,” Tasy said
of the concerns her organization has over Plan B, and its
increased availability through over-the-counter sale.
“There are a lot of issues here.”
“It certainly benefits Planned Parenthood, but not women and
children,” Tasy said.
Tasy said that court documents obtained by New Jersey Right to
Life showed that Planned Parenthood entered into a sweetheart
deal with Barr Pharmaceuticals, the current owner of Plan B, in
which Bar agreed to allow Planned Parenthood to purchase the
morning after pill at a fixed rate of $4.50 and $4.25 for the
next five years. Tasy said the arrangement enables Planned
Parenthood to sell the product at a higher rate and reap a hefty
profit and that Planned Parenthood boasts on its own website
that it has distributed Plan B to over one million women in the
last year alone.
Tasy said some of the concerns surround sexually transmitted
She said that although proponents of Plan B continue to claim
that the morning after pill will reduce abortions and not
increase STDs, experience in countries like the U.K. and
Scotland which have made Plan B available for about 15 years
show the exact opposite effect with both abortions and STDs
increasing for that period.
“Under this two-pronged marketing approach, the FDA has created
a new process that has neither been authorized by Congress nor
undergone a formal rule-making process. We call on
Congress to hold hearings to review and suspend the approval of
the morning after pill without a prescription,” said Tasy.
The head of the local Planned Parenthood chapter, based in
Morristown, said the group’s motivation is not financial but
ethical and medical in promoting Plan B.
“Our motivation is not financial,” said Jeffrey Brand president
and chief executive officer of Planned Parenthood in the Greater
Northern New Jersey. “Our motivation is so that American
women have access to tools they need to prevent unwanted
pregnancies. Right now women need a prescription, so
making it more readily available in a pharmacy is truly our
“Planned Parenthood is a not for profit, mission driven, health
care provider. Our services help women prevent unwanted
pregnancies, and all our services provide a sliding fee scale,”
said Brand. “Right now women need a prescription by making
it more readily available.”
“For the last three years the Bush administration and the FDA
have attempted to beauracratically derail this,” said Brand.
“It is only because of pressure applied through the efforts of
Sen. Hillary Clinton, D-N.Y., Sen. Patty Murray, D-Wash.,
Planned Parenthood and others that we are finally getting
science overriding ideology.”
Brand said that according to the Alan Guttmacher Institute,
emergency contraception currently prevents 100,000 pregnancies
in the United States each year, and they estimate that 51,000 of
those pregnancies would have ended in abortion.
“If the right-to-lifers really cared about reducing the number
of abortions, rather than making political points, they would be
championing rather than challenging,” Brand said.
Also jumping on the support wagon for over-the-counter sale of
Plan B is the Morris County Chapter of the National Organization
for Women (NOW), except they’re not satisfied.
Mavra Stark of Boonton, president of Morris County NOW, said the
FDA’s announcement is unacceptable.
“In fact, Plan B, the manufacturer’s name for the morning after
pill, will not truly be an over-the-counter item at all, but a
behind the counter indignity for all women,” Stark said.
Stark said the organization believes that the FDA’s announcement
is a “bad deal that compromises the health of women in this
“While it is surely good news that women over the age of 18 will
have easier access to Plan B, it is totally unacceptable that
the same access is being denied to millions of young women, who
arguably need access most,” Stark said. “The
behind-the-counter arrangement is an unnecessary invasion of all
women’s privacy and autonomy, and it cannot be tolerated.”
“Morris County NOW is not celebrating today. We will
redouble our efforts to make the morning after pill available
without regard to age as a true over-the-counter item, one that
any woman can pick up from any shelves in any drugstore,” Stark
said. “To be content with less than that is an abandonment
of the needs of young women and an acceptance of the odious view
that women must be treated like children.”