Stop Over-the-Counter Approval of the Morning-After Pill, (CWA Action Alert)

The Food and Drug Administration (FDA) will decide this week whether to allow Plan B, a morning-after pill, to be available over-the-counter to anyone who is over 16 years old and to those younger than 16 with a prescription. After the FDA denied its first application for over-the-counter status last May, Barr Labs, the owner of Plan B, filed a new application with this marketing scheme, purportedly to address concerns that the drug has not been adequately tested for the health effects on adolescents.

Proponents loudly claim that easy access will reduce pregnancy rates and abortions. Not so, according to studies - even studies designed by morning-after pill advocates.

A new study released last week showed that easy access did not increase "unprotected sex"; but buried in the announcement was the startling admission that the study's purpose was to show a decrease in pregnancy rates. Surprise! No statistical difference was found among women who had three packs of the drug in hand, those who went to a pharmacy to get it, or those who had to go to a clinic.

The study also found that women (15 - 24 years old) who had the drugs in hand were likely to use it more than once in a six-month period. Yet, no studies have been done to determine the medical effect of multiple uses of this high dose of hormones.

Other studies show no decrease in the number of abortions where the drug is easy to obtain.

Abortion advocates - including congressmen - are exerting immense pressure on the FDA to make this drug easy to get. They argue that other countries make it available, so the U.S. should as well. Not mentioned is that these countries also experience a surge in sexually transmitted diseases when the drug is available without prescription.

And one country found that the most frequent buyer of the morning-after pill is men, who sometimes slip it to women without their knowledge or consent.

Easy access to the morning-after pill does not reduce pregnancy rates, increases sexually transmitted disease rates, and accommodates men who seek to abuse women and girls.

Please contact the FDA now and urge the agency to continue requiring a prescription for the morning-after pill. Tell the FDA, "Please do not approve any scheme to make the morning-after pill available without prescription." The FDA's phone number is (301) 594-5400. Or, click here for a prepared email.

The FDA's deadline is January 22, 2005. We know that pro-abortion groups are already asking their members to call the FDA as well. Time is of the essence, so please do not delay. Thank you.

Dear Colleague:

Greed-driven manufacturers of the morning-after pill (MAP) are hoping that the FDA will soon approve this abortifacient drug for over-the-counter sale. Eight months ago the FDA rightly rejected this very bad idea. Nothing has changed since then. Call 888-463-6332 to urge them to do so again.

Steven W. Mosher, President
PRI Weekly Briefing
20 January 2005 Vol. 7 / No. 3

OTC MAP is Back
By Joseph A. D'Agostino

Despite deciding against non-prescription sales of the morning-after pill (MAP) just last May, the Food and Drug Administration (FDA) could decide as early as today to effectively reverse that decision. Taken within 72 hours after intercourse, MAP prevents pregnancy-or so its advocates say.

The American MAP's manufacturer has even proposed a novel, never-before-approved method for regulating the drug's sale in order to get it into the hands of as many women and girls as possible while satisfying the FDA's safety concerns. The campaign to expand MAP's availability, both in the United States and around the world, rests on two
lies:

That MAP is safe for women and girls, and that MAP only prevents pregnancy rather than killing unborn children.

The second lie is the more blatant. MAP is often called "emergency contraception," and under that misleading name it has been introduced around the world with government and international funds that are not supposed to go for abortion. Something called "contraception" should prevent conception from occurring--that's what "contraception" means--but MAP doesn't always do this. Instead, it prevents the implantation of an already conceived child, killing an unborn baby in the early stages of life.

The push for MAP (sold under the brand name "Plan B" in the United States) is so intense that pro-abortion experts have redefined pregnancy to begin at "implantation," rather than "conception," thus allowing them to claim that MAP has no abortifacient effect whatsoever. This Orwellian ampering with language is intended to deceive the public-including anti-abortion women who are willing to use contraceptives but not abortifacients-and is almost as disturbing as MAP itself.

If MAP kills unborn children, is it nonetheless safe for mothers, particularly the teenagers who will get their hands on MAP without medical supervision if it is sold over the counter? Plan B's manufacturer, Barr Laboratories, and leading American feminist organizations say yes. But as we noted in a 2004 report, Under the Table: Why the U.S. Food and Drug Administration Should Not Approve the Over-the-Counter Distribution of Morning-After Pills, "Berlin-based Schering, manufacturer of two MAP products primarily used in Western Europe. . .has refused to sell MAP in
countries where it is available without a prescription."

As for Plan B itself, a "December 2003 FDA advisory committee meeting revealed that certain MAP research issues were not resolved," said the report. "These include evidence on long-term safety, especially as to ectopic pregnancy; safety in [already] pregnant women and MAP-exposed fetuses; use as primary form of ontraception. . .and interactions with other drugs." Perhaps the greatest concern is that if MAP is available over the counter, women and girls will use it repeatedly rather than take care to use contraception or abstain. This could lead to unknown consequences.

Plan B contains levonorgestrel, the same active ingredient in the contraceptive Norplant. Norplant has been yanked from the American market because it's so dangerous.

Barr says it wants pharmacies to keep MAP behind the counter and sell it only to those 16 years old and older. This is a dubious stratagem at best, one never before approved by the FDA. Does anyone doubt that minors will easily be able to get their hands on it without their parents' knowledge? Younger girls will get older friends to buy the drug for them-or their boyfriends will, since so many studies show that many boys and men having relations with 13-, 14-, and 15-year-old girls are several years (or more) older than their girlfriends.

Even though there is little data on how MAP affects younger teenagers, feminists want 13-year-olds to get MAP. Referring to Barr's 16-year-old minimum, the National Organization for Women (NOW) said January 18, "The National Organization for Women opposes that restriction."

Over-the-counter sales of MAP will likely greatly increase its use, judging from other countries' experience. "Sales of the morning-after pill have soared 60% in the 12 months since the emergency contraceptive became available over the counter in pharmacies," reported the Australian on January 13. "The rise in sales sparked a warning from Australian Medical Association president Bill Glasson that Postinor-2 should not be used as a drug of convenience. Health Minister Tony Abbott [who is pro-life] last year expressed concern about reports girls as young as 13 had requested the emergency contraceptive." (Yes, there is the phrase
"emergency contraceptive.")

If you oppose over-the-counter availability of MAP, please express your opinion politely but firmly to the FDA. Go to:

http://www.fda.gov/cder/comment/commentdrug.htm

Or call the comment line, 888-463-6332.

Do it now.

Joseph A. D'Agostino is Vice President for Communications at the Population Research Institute.

PRI
P.O. Box 1559
Front Royal, VA 22630
USA

Phone: (540) 622-5240 Fax: (540) 622-2728
Email: jad@pop.org
Media Contact: Joseph A. D'Agostino
(540) 622-5240, ext. 204
_________
© 2005 Population Research Institute. Permission to reprint granted. Redistribute widely. Credit required.

Holly Patterson took the new abortion pill and then, in intense pain, died. Her parents are suing the drug matter and Planned Parenthood, them gang who gave it to her.

Spread the word.

Yours sincerely,

Austin Ruse
President

CULTURE & COSMOS

December, 28 2004 Volume 2, Number 22

Parents of Abortion Drug Victim Sue Drug Company and Planned Parenthood

The parents of a young woman whose death was linked to the abortion pill Mifeprex have filed suit against the drug's maker for wrongful death and product liability. Holly Patterson, who died at the age of 18 in September of 2003, is the third woman since the drug's 2000 approval to die in connection with taking Mifeprex.

On Sept. 10, 2003, only a month after turning 18, Patterson took Mifeprex, also called mifepristone and RU-486. Four days later she had her boyfriend take her to the emergency room because of heavy bleeding and cramps. She told her parents the pain was from severe menstrual cramps. She was release by the hospital after being given pain medication. Three days later on Sept. 17, she returned to the hospital where she experienced intense pain and bleeding and then died. Patterson's autopsy determined her death was "due to endomyometritis (inflammation)" caused by "therapeutic, drug-induced abortion."

A spokeswoman for Danco Laboratories, the maker of the abortion pill, said, "no causal relationship between the use of the Mifeprex regimen and the unfortunate death of Ms. Patterson has been established." Mark Crawford, the lawyer representing Patterson's parents said the suit is not intended to cause media hype. "I haven't filed this thing to get publicity. It's filed because there's been some wrongdoing on the part of the drug manufacturer and drug sponsor here in not getting the warning out."

Officials with the Federal Drug Administration (FDA) believe the potential for Mifeprex to cause significant harm to those who take it to be so serious that on Nov. 15 they strengthened the warning label that comes with the pills. "The new warnings to health care providers and consumers include changes to the existing black box on the product to add new information on the risk of serious bacterial infections, sepsis, and bleeding and death that may occur following any termination of pregnancy, including use of Mifeprex," according to an FDA statement.

A New York Times story reported that in addition to the three deaths linked to the drug, the F.D.A. has received 676 reports of problems. Among those were 72 cases of blood loss requiring transfusions and 7 cases of serious infections. According to the story the stronger warning label was a step in the right direction for Patterson's father but more steps should be taken. "Holly did not die in vain," said Patterson's father. "I'm not convinced this drug is safe and I still think it should be banned.''

Some leaders in the pro-life community believe that regardless of the final verdict the case could be significant. Information about Mifeprex that becomes public as a result of the pre-trial investigation may prove to be embarrassing to the drug maker. The lawsuit also names Population Council; Planned Parenthood of Golden Gate, where Patterson received the medicine; the doctor who treated Patterson; and the operators of the hospital where Patterson died. None of the organization would provide comment. The amount of money sought in the suit was not specified.

Culture of Life Foundation
1413 K Street, NW, Suite 1000
Washington DC 20005
Phone: (202) 289-2500
Fax: (202) 289-2502
E-mail: clf@culture-of-life.org
Website: http://www.culture-of-life.org

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