Mavra Stark, President of Morris County NOW, is quoted extensively in this article

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 prescription.

By 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 FDA.

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 older.”

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 Mendham.

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 B.

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 conservative.

“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 diseases.

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 motivation.

“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 country.”

“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.”