13 July 2007
Plan B: More Sales, Less Medical Care
Today [13July] the Washington Post trumpets news that sales of the Plan B morning-after-pill have doubled since the FDA allowed it to be sold over-the-counter ("OTC") last fall.
Several points need to be made.
First, the drug's supporters complain about FDA's requirement that Plan B remain a prescription drug for girls 18 or under. Physicians consulting with FRC believe Plan B may affect adolescents differently from adults, and it is alarming that Plan B's manufacturer did not present adolescent safety data to FDA. Consequently, FDA decided that it could not be sold safely to adolescents without a prescription.
When FDA concocted a legally dubious marketing scheme combining OTC adult sales with adolescent prescription sales, FRC, Concerned Women for America, and the American Association of Physicians and Surgeons took FDA to court. That litigation is ongoing.
Second, we were concerned that the label comprehension tests for Plan B, conducted by Plan B's manufacturer, indicated that 1 of 3 women tested did not realize Plan B was not a replacement for traditional contraceptives. Without physician oversight, this might lead to Plan B's overuse. [We do not know the long-term effects of this potent drug on the female body.]
Finally, concerns by pharmacists and hospitals about Plan B's abortifacient properties are credible: the drug's label, approved by FDA, states that Plan B "may inhibit implantation of the embryo." Doubling the use of a bad drug is nothing to celebrate.
[FRC, 13July07; http://www.washingtonpost.com/wp-dyn/content/article/2007/07/12/AR2007071202146.html]
Studies in Europe and the USA over the last 5 years consistently have shown that increased access to emergency contraception (Plan B) does NOT decrease surgical abortion; instead abortion numbers remain constant or have increased.
The recommendation of Food and Drug Administration (FDA) advisory panels to allow the morning-after pill (MAP – also called EC) to be sold over the counter (OTC) is not supported by medical facts and may very well bring about devastating consequences.
Granting the morning-after pill over-the-counter status will lead women and young girls to think the drug poses no greater threat than other medicines available without a prescription.
But the morning-after pill is not "just another contraceptive," and even a passing glance at the facts is sufficient to prove it does not belong on the pharmacy shelf near Tylenol and baby aspirin.
Women taking a regular-strength birth control pill generally meet with their physician at least once per year because the drug has been linked to fatal conditions such as heart attack, stroke and breast cancer.
The morning-after pill is 40 times stronger than regular birth control, and it therefore poses an even greater risk of causing dangerous side effects in women and girls who take the drug unsupervised.
The dangerous impact of the morning-after pill will be felt especially by teen girls, who have little if any grasp of their own medical histories and who will see the drug's easy availability as a license to have promiscuous sex without the chance of getting pregnant. This false sense of security may lead some girls to take the pill frequently, though there have been no clinical studies on its long-term effects.
As a culture, we're clearly confused. We go out of our way to keep cigarettes out of the hands of teenagers, but this policy would make the morning-after pill the new Saturday night party favor of choice.
Supporters say the FDA's decision will reduce the number of abortions; however, several recent studies/statistics in Sweden, the UK, Scotland, and San Francisco show that the number of abortions either remains the same or increases.
EC/MAP gives people another false hope that there are no consequences to one-night stands and promiscuous behavior. There are.
The Bush administration must get the FDA back on the track of protecting health rather than pushing the pet projects of Planned Parenthood & Co. [29Dec03, USA Today; 30 Dec 2003 Pro-Life E-News http://www.usatoday.com/news/opinion/editorials/2003-12-30-oppose_x.htm]
The morning-after pill, which contains hig
h doses of a hormone used in birth control pills, was approved by the FDA as a prescription drug in 1998. If taken within 72 hours of unprotected intercourse, it “prevents” 89% of pregnancies. This is at best a half-truth.
[30 Dec 2003 Pro-Life E-News; http://www.usatoday.com/news/opinion/editorials/2003-12-30-our-view_x.ht 12/29/2003 USA Today]
Members of Congress held a news conference on January 28, 2004 , to discuss the dangers of the Food and Drug Administration (FDA) making Plan B "The Morning After Pill" an over-the-counter product. The participants were Rep. Dave Weldon, R-FL, Rep. Donald Manzullo, R-IL, Rep. Melissa A. Hart, R-PA and Rep. Chris Smith, R-NJ.
Plan B is one form of MAP, "The Morning After Pill", used as an emergency contraceptive.
It differs from RU-486 in that RU-486 is specifically used to abort a known pregnancy.
Plan B, however, may have multiple actions: it may inhibit implantation (early abortion), delay ovulation, or prevent fertilization. Inhibiting implantation has not been proven by studies; however, it has not been disproven. The actual mode of action has simply not been proven by studies at this time.
Some groups want a warning on the label to make users aware that it may prevent implantation [i.e. cause an abortion].
The representatives at the news conference were all in agreement that this drug should not be made an over-the-counter drug. In fact, on January 9, 2004, 49 Members of Congress signed a letter to President Bush urging him to reject the recommendation of the FDA advisory panel because of the threat to adolescent sexual health.
Rep. Dave Weldon released a statement saying, "The scientific fact is that 3 [3.8] million adolescents a year are infected with a sexually transmitted disease. The scientific fact is that no one knows how the OTC availability of the morning-after pill will affect the sexual health of teens. There is great potential that the easy availability of Plan-B will contribute to unsafe sexual practices and the future spread of STDs and HIV-AIDS among adolescents."
[By Tony Perkins Pres., Family Research Council, D.C.]
These pills are also called "emergency contraceptive" pills (ECPs) because they are taken after intercourse.
The regimen approved by the Food and Drug Administration (FDA) for ECPs identifies 6 brands of ordinary birth control pills containing estrogen, and progestin, and requires that a high dose be taken within 72 hours of "unprotected intercourse," followed by a second high dose 12 hours later.
Preven, marketed by Gynetic and approved by the FDA in September 1998, is a kit containing the pills plus a pregnancy test to rule out existing pregnancy from earlier intercourse. Preven tends to cause a great deal of nausea because of the high artificial estrogens consumed.
In 2000, both the House and Senate approved an amendment prohibiting the use of federal funds to distribute or prescribe postcoital emergency contraception in any elementary or secondary school, but the amendment was dropped in conference committee at the insistence of the Clinton Administration.
The FDA is considering a proposal to allow morning-after pills to be sold over-the-counter without a prescription. The morning-after pill in question is called Plan B, a progestin levonorgestrel-only pill that may have both contraceptive and abortifacient properties.
On December 16, 2003, two FDA committees held a hearing and voted that the Plan B pills be made available over-the-counter. The recommendation is not binding. The FDA Commissioner Mark McClellan will make the final decision, though a firm date is not set. On February 13, 2004, the FDA delayed a decision for 90 days stating it needed more time to review additional data. A delay also occurred in May 2005, and again in August 2005.
One of the possible effects of the morning-after pill is to abort a newly conceived human life by preventing implantation in the uterus (womb), although no scientific studies have as yet been able to confirm this beyond doubt.
[Cathy Cleaver Ruse December 17, 2003 press release, "Official Calls FDA Ruling on 'Plan B' a 'Reckless Experiment on Women'," and Maureen Kramlich, "Taking Life at the Corner Drugstore," Life Issues Forum, 19Dec03, www.usccb.org/prolife/issues/contraception/morningafterpill.htm]
For more information on EC/ MAP, click "Birth Control" in the left menu, and then click Emergency Contraception.