Last week, we wrote about a controversial decision by HHS Secretary Kathleen Sebelius, who overruled the FDA’s decision that emergency contraception should be made available over the counter to women of all ages. On Friday, former FDA official Susan Wood issued her response to the move in the Washington Post, rejecting Sebelius’s claim that more data is needed on safety and label comprehension for the youngest of possible emergency contraception users: …this type of age restriction, and worries about the use of medicines by teenagers, have not been applied to other products…Indeed, for no other over-the-counter medication has the FDA ever required extra data for a particular age group. (This extra data on younger teenagers was provided to the FDA in the latest application by the company.) Like what you’re reading? Our Bodies Ourselves needs your support to continue providing trusted health info!Act NowBut somehow, the prescription requirement for Plan B — which is very safe and impossible to overdose on — remains in place for those younger teens who are in the unfortunate situation of being at risk of pregnancy and who need emergency contraception immediately. Wood also notes that because the age restriction remains, access for older women … More
Our Bodies, Our Blog
Evidence Trampled By Politics: HHS Secretary Sebelius Overrides FDA Decision on OTC Emergency Contraception
Yesterday, Health and Human Services head Kathleen Sebelius interfered with the FDA’s decision that emergency contraception could safely be made available over the counter (OTC) without a prescription to women and girls of all ages. The drug is already available without a prescription for women 17 and older, after years of political wrangling. Advocates have worked to ensure OTC access because emergency contraception is most effective when used as soon as possible, and time, distance, money, and privacy can be serious barriers to getting a prescription and obtaining the drug in time to prevent pregnancy. The FDA’s Center for Drug Evaluation and Research (CDER) had completed a review of the issue and concluded that Plan B One-Step emergency contraception should be available OTC to younger women, which Commissioner Margaret Hamburg explains: Like what you’re reading? Our Bodies Ourselves needs your support to continue providing trusted health info!Act NowBased on the information submitted to the agency, CDER determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could … More
Earlier this year, we wrote about the Center for Reproductive Rights’s efforts to bring attention to young women’s continued lack of over-the-counter access to emergency contraception, despite a lack of evidence for the current age-based cutoff. In March of 2009, a judge ordered the FDA to extend over-the-counter access to 17-year-olds, and also to reconsider these age restrictions in general. Last week, the Center filed a motion for civil contempt against the FDA arguing that the agency has failed to reconsider the age restrictions for women younger than 17. The Center has background materials and more information at http://reproductiverights.org/en/feature/the-center-takes-the-fda-back-to-court. The group is encouraging supporters to contact the FDA asking the agency to “respect the findings of its own scientific review panel and take immediate action to end restrictions on emergency contraception.” Like what you’re reading? Our Bodies Ourselves needs your support to continue providing trusted health info!Act Now[In other we’re-still-waiting news, almost two years after the administration announced that they were going to review the controversial “conscience clause,” we still haven’t seen any action. As far as I know, the proposed public comment period never happened.]
In June, we wrote about the FDA’s Advisory Committee for Reproductive Health Drugs recommendation to approve ulipristal acetate (brand name “ella”) for emergency contraception. On Friday, the FDA did approve the drug, as a prescription-only emergency contraceptive to be taken up to 120 hours (5 days) after contraceptive failure/unprotected sex. Existing “Plan B”-type emergency contraception is currently approved for use up to 72 hours. Despite the five-day use window for this drug (and the three-day window for others), some media outlets persist in calling it a “morning-after” pill. Ahem. At the time of our June post, a transcript of the Advisory Committee meeting – which includes the text of presentations and detailed discussion of the drug – was not yet available. That transcript is now online [PDF], including comments from representatives of Planned Parenthood and the National Women’s Health Network. Like what you’re reading? Our Bodies Ourselves needs your support to continue providing trusted health info!Act NowSee our previous post for further discussion of the new emergency contraceptive.
The FDA’s Advisory Committee for Reproductive Health Drugs yesterday reviewed a new drug application for ulipristal acetate, an emergency contraception that prevents pregnancy after intercourse. This particular drug has been available in Europe under the brand name ellaOne since May of 2009 and is intended for use up to five days after unprotected sex or contraceptive failure. Most other emergency contraceptions sold over the counter in the United States are officially approved for use up to three days (72 hours), although it is widely accepted that these others drugs (such as versions of Plan B) are also effective for up to five days. See our previous post on the topic for further discussion of this aspect, as well as some fairly recent studies and anti-choice objections to the product. The FDA committee voted unanimously to recommend approval; the Agency itself will now need to decide whether the drug is approved. The National Women’s Health Network released a statement [PDF] urging the FDA not to reverse the committee’s recommendation (as the FDA did in the initial, controversial Plan B decision in 2004), and commenting on anti-choice opposition, which has centered on whether the drug could be used for abortion or otherwise … More
The Center for Reproductive Rights has launched a campaign to raise awareness of the continuing prescription status of emergency contraception for young women, while older women have over-the-counter access – and they’re doing it with bunnies. As the bunnies note: Bunny 1: Wait, I thought you didn’t need a prescription anymore. Like what you’re reading? Our Bodies Ourselves needs your support to continue providing trusted health info!Act NowBunny 2: You don’t. But you still have to go to the pharmacist, show your ID, and if you’re lucky, escape without the Stares of Shame. Bunny 1: Yikes. Why can’t you buy it like a condom? Bunny 2: Excellent question. Scientists say there are no medical grounds for limiting access to emergency contraception. But instead of putting our health first, the Food and Drug Administration overruled their own scientists and bowed to political pressure. Bunny 1: Whoa. The video further explains that “On March 23, 2009, the Center won a major victory when a judge ordered the FDA to reconsider making emergency contraception available over-the-counter to women of all ages. A year later, the FDA still isn’t moving forward. Even though there is no scientific basis to continue restrictions on emergency contraception.” … More
A recent ABC news piece and two new journal articles (in The Lancet and Obstetrics and Gynecology) have drawn attention to an emergency contraception drug that is not currently available in the U.S. but apparently has been submitted to the FDA for review. Emergency contraception pills (EC) currently available in the U.S. are intended to be taken within 72 hours (3 days) of unprotected intercourse or contraceptive failure. The drug new drug, ellaOne (ulipristal acetate), can be taken within 120 hours (5 days), providing a longer period in which to prevent pregnancy. [It’s worth noting here that women have long been advised that existing EC options can also be taken up to 5 days after intercourse, although that’s not the “official” approved recommendation on the drug inserts]. Anti-choice groups such as the American Association of Pro-Life Obstetricians and Gynecologists argue that the pill could cause abortions and be an OTC abortion pill in the U.S., using a definition of “pregnancy” that includes a non-implanted fertilized egg, a definition that is generally not medically or scientifically accepted. These arguments were also presented during debate over the approval of Plan B. Like what you’re reading? Our Bodies Ourselves needs your support to … More
Via AirForceTimes I learned that the Compassionate Care for Servicewomen Act [S 2904/HR 4386], a bill that would require emergency contraception to be made available at all military health care treatment facilities, was introduced in mid-December by sponsors Al Franken (D-MN) in the Senate and Michael Michaud (D-ME) in the House. NARAL Pro-Choice America praised the bill, noting the bill’s potential affect on women serving overseas, stating, “Sen. Franken’s bill is based on the principle of fairness: Women in the military serving overseas should be able to access EC the same way women stateside do.” The bill has been referred to the Senate Committee on Armed Services. A similar bill was introduced in 2007 but failed to make it out of committee. Like what you’re reading? Our Bodies Ourselves needs your support to continue providing trusted health info!Act NowThe blogger at Lettuce Spray called the Senate Committee on Armed Services about the legislation (something she also encourages others to do), and learned that “the committee has not yet scheduled anything for January, and are not scheduled to start any hearings until after January 20th. As soon as a hearing date is set (if at all) it will be posted to … More
If you tried taking the survey about emergency contraception and found it closed this weekend, it’s because the limit for the basic plan was reached. The survey site has been upgraded, so please give it another try. Thanks! Like what you’re reading? Our Bodies Ourselves needs your support to continue providing trusted health info!Act NowAnd if this is the first you’re hearing of it, read our previous post about the book that Heather Munro Prescott, a history professor at Central Connecticut State University, is writing on the history of emergency contraception and how she could use your input.
Have a few moments to take a survey about emergency contraception? Heather Munro Prescott, a history professor at Central Connecticut State University, is writing a book on the history of emergency contraception, and she’s looking for input from women who have used EC — as well as input from their partners, health care providers and activists. Prescott is especially interested in hearing from women who used EC in the 1960s, 1970s and 1980s. Like what you’re reading? Our Bodies Ourselves needs your support to continue providing trusted health info!Act NowYes, emergency contraception has been around for decades, though most of what we know about EC is connected to the FDA’s recent approval of over-the-counter access to Plan B, a progestin-only pill available to women as young as 17 without a prescription. It reduces a woman’s risk of pregnancy by up to 89 percent when taken within 72 hours of unprotected sex (research indicates Plan B can be taken up to 120 hours after, but the pill is more effective the sooner it’s taken). Other types of EC are described at the Emergency Contraception website, an independent, peer-reviewed resource operated by the Office of Population Research at Princeton University and the Association of Reproductive Health Professionals. The website also … More