FDA decision under debate
Dr. Robert Shapiro, a board certified obstetrician and gynecologist with Fayette Specialty Associates in Uniontown, praised a recent Food and Drug Administration ruling allowing anyone over 18 to purchase emergency contraception without a prescription. Barr Pharmaceuticals Inc., the makers of Plan B emergency contraception, plan to have the product available to all pharmacies by the end of the year, according to pharmaceutical representatives.
Shapiro said he believes the Plan B contraception is a good option for women whose first method of birth control has failed – someone who forgot to take their daily birth control pill or whose partner’s condom broke during sex.
Shapiro said it is important people realize Plan B is not an abortion pill. He said studies have shown the 75-milligram progesterone pills, given twice 12 hours apart, do not harm a fetus if the woman is already pregnant.
“It’s very safe and there are few side effects,” Shapiro said, noting that the contraception works by making it difficult for sperm to fertilize an egg and by creating an unfavorable environment for conception in the womb.
In addition, Shapiro said studies conducted in countries where emergency contraception is available over the counter have not seen a rise in promiscuity.
The FDA’s decision to only allow women 18 and older to purchase Plan B without a prescription was a compromise of sorts. The decision to allow women in the United States to purchase the emergency contraception over the counter faced heavy opposition from those who believe increased availability may increase promiscuity and promote use of the pills by sexual predators.
Deirdre McQuade, director of planning and information for the U.S. bishops’ Secretariat for Pro-Life Activities, said the recent decision to allow over-the-counter sales of Plan B, also known as “the morning-after pill,” “defies common sense” and is “completely unacceptable” to the Catholic Church.
Jerry Zufelt, spokesman for the Greensburg Catholic Diocese, said the Plan B drug, in addition to including an extremely powerful dose of an artificial hormone, can also be an abortifacient, something causing abortion.
He noted that the manufacturer has admitted the drug may prevent a newly conceived embryo, which is the beginning of human life, from implanting and surviving in the womb. That would be an early abortion, added Zufelt.
“Pregnancy is the creation of a new human life. The Plan B drug and its approval unfortunately reinforce the all-too-common view that pregnancy is just another disease or pathological condition,’ said Zufelt.
Barr Pharmaceuticals officials maintain that Plan B is not a substitute for other birth control methods and that it should be used only in the case of emergencies and not on a regular basis.
Planned Parenthood, a national group that teaches sex education and believes that individuals should have the right to make reproductive decisions, maintains that 41 other countries, including Canada and Australia, already let women buy emergency contraception without a prescription.
According to the FDA’s ruling, girls 17 and younger will still need a prescription to purchase the pills, which contain a concentrated dose of the same drugs found in many regular birth-control pills.
Those who support the FDA’s ruling – several women’s advocacy and medical groups – claim easier access to the morning-after pill could halve the nation’s 3 million annual unplanned pregnancies and cut back on the number of performed abortions.
Representatives with the pharmaceutical company said women have a difficult time acquiring a prescription from their doctors when emergencies occur on the weekends and holidays, noting that the pills must be taken as soon as possible in order to be most effective.
If a woman takes Plan B within 72 hours of unprotected sex, she can lower the risk of pregnancy by up to 89 percent, according to information provided by Barr Pharmaceuticals.
The pharmaceutical company maintains that Plan B is not an abortion pill in that it will not work or have any effect on the baby if a woman is already pregnant.
Shapiro said he believes many women are not aware morning-after pills such as Plan B are available, citing statistics that show less than 5 percent of women nationwide are aware emergency contraception exists.
Though he writes one to two prescriptions for Plan B a year, Shapiro said women sometimes have a hard time getting the prescriptions filled locally.
However, corporate spokesmen for Rite Aid, Eckerd and Wal-Mart pharmacies all said Plan B will be made available over the counter once the FDA approves the consumer packaging.
Kevin Gardner, senior manager of corporate communications for Wal-Mart, said the product will be kept behind the counter and anyone wishing to purchase the medication must show identification.
Wal-Mart, according to Gardner, currently carries Plan B for sale by prescription.
The FDA approved prescription-only sales of Plan B in 1999. Barr Pharmaceuticals began their quest to have Plan B made available over the counter in 2003.