This Week Marks Ten Years of Women Accessing Medication Abortion in the U.S.

On September 28, 2000, the FDA approved the drug mifepristone, in combination with misoprostol, for usage in a medical abortion pill. Formerly known as RU-486 and now marketed as Mifeprex, the drug offers women an alternative to surgical abortion.

According to a Guttmacher Insititute report (PDF), nearly half of pregnancies among American women are unintended, with 40 percent of these pregnancies resulting in abortion. Although the number of abortions performed in United States has decreased in the past decade, the number of medical abortions using the pill has grown. In 2007, an estimated 21% of all abortions performed prior to nine weeks’ gestation used medication abortion.

As Jodi Jacobson writes:

The earlier in an unintended pregnancy an abortion occurs, the safer and less costly it is. Medication abortion is only appropriate for unintended and untenable pregnancies up to nine weeks.  Availability of medication abortion has meant that an increasing share of abortions are early, and an increasing share of early abortions are done before six weeks or before nine weeks.

Besides the critical importance of safety and cost-effectiveness, medical abortion also provides an alternative to having an abortion performed in an operating room. For many women, being able to have the abortion experience in the privacy of their own home is more comfortable.

However, approval of mifepristone has not increased general access to abortion services as much as many reproductive health workers initially hoped. In 2009, Dr. Lawrence Finer of the Guttmacher Institute said:

Instead, almost a decade later, we find that women in areas that already had access to abortion now have the choice between a medication or a surgical abortion. But for most women who were not easily able to access an abortion provider before mifepristone became available, services remain difficult to obtain.

Jezebel points out one possible solution to this problem – a telemedicine program run by Planned Parenthood of the Heartland in Iowa. Women who participate in the program are able to obtain an ultrasound at any of 16 clinics, have an examination by a nurse, and talk to a doctor over a secure Internet connection. If the doctor sees no complications upon reviewing a patient’s medical records, they can unlock a box containing the pill and subsequently prescribe it. So far, almost 2,000 women have gained access to abortion services through this program.

Additionally, as author Irin Carmon states in the same post, this method makes it more difficult for anti-abortion activists to interfere with the process, increasing the safety and comfort of patients and physicians.

Ten years after its FDA approval, mifepristone has yet to substantially extend its reach beyond areas where access to abortion already existed. However, within a decade, it has become a significant part of reproductive health in the United States, and research data suggests its continued growth as an option for safely terminating unwanted pregnancy.

Men who have Sex with Men Still Prohibited from Donating Blood

On June 11^th the Federal Advisory Committee on Blood Safety and Availability refused to recommend a change in restrictions that would allow men who have sex with men (MSM) to donate blood. The review began after Senator John Kerry and seventeen of his colleagues sent a letter to the Food and Drug Administration (FDA) asking them to change their outdated policy. This is the third time since 2000 that the FDA has reviewed and retained the ban on donations from MSM.

Currently, if a man has had sex with another man even once since 1977 he is banned from donating blood for his entire lifetime. The only other people who are never allowed to donate are people who have sex for money, intravenous drug users, and people who have tested positive for HIV. People who have had heterosexual sex with someone they know to be HIV-positive or someone who has had sex with a commercial sex worker are prohibited from donating blood for one year.

The committee admitted that the current system is flawed “because it permits ‘some potentially high-risk donations while preventing some potentially low-risk donations.’” The committee recommended that health authorities create a system that accounts for individual behavior as opposed to generalizations about large groups of people. The committee’s recommendations, while encouraging, are not binding.

Both the American Red Cross and the American Association of Blood Banks report that the current FDA ban on MSM blood donation ‘is medically and scientifically unwarranted (PDF). HIV-positive individuals are already excluded from donating by a pre-donation questionnaire. The Williams Institute at the UCLA School of Law estimated that if the ban on MSM blood donation were lifted, new donors “could increase the total annual US blood supply by 0.6% to 1.4%.While these increases in the blood supply may seem modest, they would occur in an environment where blood supply shortages are common.”

The current FDA ban on MSM donating blood is not only discriminatory and rife with outdated myths about most gay men’s HIV status, it prevents healthy blood from entering the system to boot. We will keep you updated about any future reviews or changes to this outdated policy.

FDA Approves One-Pill Plan B and Lowers Age Requirement for OTC Use

The Food and Drug Administration has approved a one-pill version of Plan B, called Plan B One Step. Additionally, the FDA has approved marketing the drug to women age 17 and older. In a press release, the FDA said that with this action,“both Plan B One-Step and Plan B will be available without a prescription to women 17 years of age and older.”

These new developments come after a year of changes in the accessibility of emergency contraception for young women. We have previously blogged about these changes, including the FDA approval of a generic version of Plan B, requiring pharmacists to dispense the drug despite personal objections, and relieving age constraints to accessing it. We hope that the momentum of these positive changes carries on, and that we will continue to see barriers to women’s access to emergency contraception struck down in months to come.

FDA Approves Generic Version of Plan B As Problems Remain for Young Women’s Access

Last week, the FDA approved the first generic emergency contraception pill, known as levonorgestrel. The drug will be available to women ages 17 and older beginning Aug. 24, 2009, when Plan B’s over-the-counter patent protection expires.

This news marks considerable progress in broadening  women’s access to affordable emergency contraception; even though the FDA said last April that it would allow over-the-counter sales of Plan B to women age 17 or younger, in reality,  women under 18 still do not have access to the drug. From MedPage Today:

…when the FDA said it would allow OTC sales of Plan B to 17 year-olds it meant that the FDA would allow the drugmaker — Duramed Pharmaceuticals of Cincinnati — to submit an application for OTC use by 17-year-olds.

As an FDA employee, [Siobhan DeLancey, who wrote the FDA press release announcing approval of generic Plan B] couldn’t say whether or not Duramed had submitted such an application, but she could say that no application for OTC sales to 17-year-olds has been approved.

Thus, the only way a 17-year-old can acquire the drug — whether brand name or generic — is with a prescription.

Watson Pharmaceuticals, the company who produces the generic levonorgestrel tablet, plans to market the drug under the name “Next Choice” and “launch the product shortly.”

Federal Judge Relieves Constraints on Plan B

Good news for reproductive rights! On Monday, a federal judge ruled that the Food and Drug Administration must make the emergency contraceptive Plan B available without a prescription to anyone aged 17 and older. Currently, the medication is only available over the counter to customers 18 years and older. Individuals under 18 can obtain Plan B with a prescription.

Judge Korman, who issued the ruling, stated his belief that the FDA had “improperly bowed” to political pressure from the Bush Administration when it set 18 as the age limit. Because Plan B must be taken within 72 hours of intercourse, it is exceedingly important that it be quickly available over the counter. Lowering age restrictions is supported by many health organizations, including the World Health Organization and the American Medical Association. We applaud Judge Korman’s decision in support of women’s reproductive rights and health.

Yaz Ads Under Fire

You might have noticed that new TV ads for the birth control pill Yaz
are mentioning that the FDA wants them to correct a few points they made in previous ads. The FDA criticized Bayer for overstating the drug’s ability to improve women’s moods and clear up acne, while understating the risks involved.

The FDA (and the attorneys general in 27 states) are requiring Bayer to run the new ads correcting the errors, a marketing campaign that is costing Bayer $20 million.

Yaz is currently the best selling oral hormonal contraception pill in
the United States, which makes the issue of setting the record straight all the more important. To read more about the controversy surrounding the Yaz advertising campaign, check out this New York Times article.