FDA Asked to OTC Morning After Pill

Women’s Capitol Corp., which distributes the “morning after” pill Plan B, has filed a request the Food and Drug Administration to allow it to sell the drug over the counter.

Plan B has been available by prescription in the United States since 1999 and the privately held company has sold about 3 million Plan B kits. If the initial pill is taken within 72 hours after having unprotected sex, Plan B reduces the risk of pregnancy to around 1 percent.

Morning after pills are available in other countries, such as France, but the sale of such drugs even by prescription is controversial in the United States due to opposition from anti-abortion activists. Since Plan B works by preventing the implantation of a fertilized egg onto the wall of the uterus, some activists view it as little more than a chemical abortion.

A decision from the FDA on the OTC application is unlikely until sometime in early 2004.

Sources:

‘Morning After’ Pill Maker Asks FDA to OTC Switch. Kate Fodor, Reuters, April 21, 2003.

Easier ‘morning-after’ access sought. Rita Rubin, USA Today, February 14, 2001.

A Man’s Right to Choose?

A few weeks ago, on the anniversary of Roe v. Wade which gave women the right to make a range of reproductive choices, Glenn Sacks wrote an cogent summary of the arguments for a men’s right to choose. Sacks writes,

When a woman gets pregnant she has the right to decide whether or not to carry the baby to term, and whether to raise the child herself or to give it up for adoption. In many states she can even terminate all parental responsibility by returning the baby to the hospital within a few weeks of birth. Yet if she decides she wants the child, she can demand 18 years of child support from the father, and he has no choice in the matter. When it comes to reproduction, in America today women have rights and men merely have responsibilities.

. . .

The “Choice for Men” movement seeks to give fathers the right to relinquish their parental rights and responsibilities within a month of learning of a pregnancy, just as mothers do when they choose to give their children up for adoption. These men would be obligated to provide legitimate financial compensation to cover pregnancy-related medical expenses and the mother’s loss of income during pregnancy. The right would only apply to pregnancies which occurred outside of marriage, and women would still be free to exercise all of the reproductive choices they have now.

At the moment there is almost no support outside of the men’s movement for such ideas, but as Cathy Young noted in an article on this topic a couple years ago, it is a direct outgrowth of feminist claims about the importance of abortion rights. Young wrote,

. . . Advocates of choice for men like to cite a passage from a Planned Parenthood statement, “9 Reasons Why Abortions Are Legal”: “At the most basic level, the abortion issue is not really about abortion. … Should women make their own decisions about family, career and how to live their lives? Or should government do that for them? Do women have the option of deciding when or whether to have children?”

Substitute “men” for “women,” and it’s hard to deny that coerced fatherhood drastically curtails a man’s ability to make key decisions about how to live his life, including when or whether to have children with the woman he loves. Think of “A Dad Too Soon,” the young husband saddled with college loans, graduate school tuition, car payments and other expenses, and forced to give up a quarter of his earnings because he made a mistake as a teenager. (His admittedly one-sided narrative also suggests that the mother’s paternity suit was partly driven by vindictiveness: Having waited for eight years, she filed the claim days after his wedding.) Yet, in the eyes of Ann Landers and many others, he deserves only a stern rebuke. Pay up and shut up. You play, you pay. It takes two to tango.

. . .

Yet, by and large, feminists and pro-choice activists have not been sympathetic to calls for men’s reproductive freedom. “If there is a birth, the man has an obligation to support the child,” says Marcia Greenberger, co-president of the National Women’s Law Center. “The distinction with respect to abortion is the physical toll that it takes on a woman to carry a fetus to term, which doesn’t have any translation for men. Once the child is born, neither can walk away from the obligations of parenthood.” (Actually, a woman can give up the child for adoption, often without the father’s consent, and be free of any further obligation.)

Indeed, on the issue of choice for men, staunch supporters of abortion rights can sound like an eerie echo of the other side: “They have a choice — use condoms, get sterilized or keep their pants on.” “They should think about the consequences before they have sex.” (The irony is not lost on men’s choice advocates or pro-lifers.) Yes, some admit, it’s unfair that women still have a choice after conception and men don’t, but biology isn’t fair. As a male friend of mine succinctly put it, “Them’s the breaks.”

Clearly there are some inequities that need to be eliminated, such as relief for men who end up being fathers thanks to the fraudulent and/or criminal actions of unscrupulous women, as well as men who are forced to pay child support for children they later find out they are not biologically related to, but going beyond that opens a can of worms that warrants proceeding very slowly.

Source:

30 years after Roe v. Wade, How About Choice for Men?. Glenn Sacks, MensNewsDaily.Com, January 22, 2003.

Study Finds No Increased Risk of Breast Cancer from the Pill

A study of more than 9,000 U.S. women ranging from 35 to 65 has found no evidence that oral contraceptive use increases the risk of developing breast cancer.

A 1996 study published in the New England Journal of Medicine had claimed that there was indeed such an increased risk, but that was a meta-analysis of 54 different epidemiological studies.

In the current study about 4,500 women with breast cancer and 4,500 without breast cancer were questioned in detail about their use of oral contraceptives, including older contraceptive pills which some researchers have suggested might be more likely to contribute to cancer because of their much larger levels of hormones.

But, in fact, the study found no increased risk of breast cancer for women who had taken such pills.

Source:

Pill does not increase risk of breast cancer. Gaia Vince, NewScientist.Com, June 26, 2002.

Contraceptive Patch Coming Soon to Europe and the United States

The BBC reported this week that the European Agency for the Evaluation of Medicinal Products has approved a contraceptive patch that has already received Food and Drug Administration approval in the United States. Women on both sides of the Atlantic should be able to buy the patch with a prescription sometime later this year.

The patch contains the same hormones as the pill — though in lower concentration since it is absorbed directly into the blood stream — and needs to be changed once a week. The patch has been designed to withstand exposure to water such as from bathing and swimming.

Clinical research of the patch found that it has fewer side effects, a higher compliance rate than the pill (i.e. women were more likely to use the patch consistently than they were to take pills consistently) and is not affected by condition by problems such as vomiting or diarrhea which can cause the pill to be ineffective.

About the only caveat with the patch is that heavier women — those weighing in excess of 196 pounds — may not receive a high enough dose of hormones and it may not be appropriate for them.

Source:

Contraceptive patch set for Europe. The BBC, February 26, 2002.

Anti-Abortion Groups Challenges Morning After Pill in Great Britain

Since January 2001, women in Great Britain have been able to buy the emergency contraception drug levonelle from pharmacists without a prescription. Now an anti-abortion group is mounting a legal challenge to this policy that could also threaten the availability of other forms of contraception.

The Society for the Protection of the Unborn Children is challenging the law based on Great Britain’s 1861 Offences Against the Person Act which makes it a crime to sell any “poison or other noxious thing” in order to cause a miscarriage.

Levonelle acts by preventing a fertilized egg from implanting itself in he womb — essentially causing a spontaneous miscarriage. SPUC agues that on that basis the drug should be illegal under the 1861 law.

Of course commonly used birth control drugs operate on the same principle, so if the court agreed with this line of reasoning all chemical birth control might be illegal. As Anne Weyman of the Family Planning Association told the BC,

Their case is about the provision [of emergency contraception] in pharmacies but in fact the same argument would apply to all methods of contraception which can prevent implantation and that would affect every method except barrier methods, sterilization or natural family planning.

So we’re talking here about something like 4.5 million women being told overnight that their method of family planning is illegal.

And beyond that, what exactly would be the legal status of abortion?
This is in the courts now, but a better approach would be for the British Parliament to pass new legislation overturning that part of the 1861 law being used here.

Sources:

Legal challenge to morning-after pill. The BC, February 12, 2002.

Head to head: contraception challenge. The BC, February 12, 2002.

New Emergency Contraception Laws Now in Effect in California, Illinois

In Illinois and California, laws affecting emergency contraception — the so-called “morning after” pill — went into effect on January 1, 2002. In both states, the new laws are designed to make access to emergency contraception easier.

California took the biggest step, allowing women to obtain emergency contraception directly from pharmacists without first seeing a doctor to obtain a prescription. Jane Boggess, executive director of the Pharmacy Access Partnership which pushed for the change in the law, told the Sacramental Bee,

Women will now be able to go directly to their pharmacists for emergency contraception, which is a significant improvement over having to make an appointment with a doctor or clinic first. Time is of essence with emergency contraception. In order to prevent a pregnancy after unprotected sex, a woman must use emergency contraception within 72 hours.

Illinois, which already allows prescriptions for emergency contraception to be obtained over the Internet, added a mandate which requires hospitals to inform rape victims about emergency contraception. The legislature had originally considered forcing hospitals to provide such drugs to rape victims, but faced opposition from Catholic hospitals that opposed to emergency contraception on religious and ethical grounds.

Source:

New contraception law takes effect. The Sacramento Bee, December 31, 2001.

New state laws pending. Christopher Wills, Associated Press, January 1, 2002.