On June 18, 2010, the US Food and Drug Administration (FDA)'s Reproductive Health Drugs Advisory Committee voted unanimously in favor of approving the new drug application (NDA) for ulipristal acetate tablets, 30 mg (ellaOne; Laboratoire HRA Pharma), for use as an emergency contraceptive.

The 11-member committee voted unanimously that sufficient information was available about the efficacy of ulipristal. They also agreed that the safety profile appeared to be acceptable for the proposed indication.

The committee's vote was based on a review of data from the ulipristal acetate preclinical and clinical development program including more than 4000 women from the United States and Europe. The panel agreed that there is no scientific evidence that at the dose recommended, ulipristal causes abortion

BACKGROUND

On October 15, 2009, the US Food and Drug Administration (FDA),s received a request for approval for ulipristal acetate, a selective progesterone receptor modulator, as an emergency contraceptive indicated for the prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure.

The proposed dosing regimen is one 30-mg tablet taken orally as soon as possible within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure. As a method of emergency contraception (EC), ulipristal acetate is not intended for routine use as a contraceptive.

Progesterone plays a pivotal role in reproduction in many species. It is involved in the control of ovulation, implantation, and maintenance of pregnancy. Progesterone mediates its physiological effects through interaction with the progesterone receptor, a member of the superfamily of nuclear receptors.

The recognition of the important role of progesterone in reproduction led to the development of synthetic progesterone receptor ligands, also known as selective progesterone receptor modulators.

Also known as CDB-2914, ulipristal acetate was originally synthesized by Research Triangle Institute (RTI) under contract with the National Institute of Child Health and Human Development (NICHD). NICHD carried out the initial preclinical and clinical development of the compound until HRA Pharma licensed-in the molecule in 2000 and took over its development.

Ulipristal acetate (17α-Acetoxy-11β-(4-N,N-dimethylaminophenyl)-19-norpregna-4,9-diene-3,20-dione) is a derivative of 19-norprogesterone that binds with high affinity to the progesterone receptor. A new molecular entity, it is the first member of a new pharmacological class of selective progesterone receptor modulators (SPRMs) designated by the “pristal” suffix.

Ulipristal acetate was approved in May 2009 by the European Commission for marketing as an emergency contraceptive within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure. The product was launched in October 2009 and is marketed today in 22 countries in Europe.

With the information obtained in clinical studies including four efficacy trials in which over 4,000 women at risk of pregnancy from unprotected sexual intercourse or failure of a contraceptive method received ulipristal acetate for EC, it is concluded that:

• ulipristal acetate reduces pregnancy risk when used up to 120 h after intercourse
• ulipristal acetate has a well-characterized safety profile, with the most frequently reported adverse events (headache, nausea, dysmenorrhea and abdominal pain) being those commonly reported in studies of EC and similar to those described for approved products
• ulipristal acetate would offer women and healthcare professionals an important new treatment option for reducing the risk of unintended pregnancy

6th Annual Parliamentarians’ Summit on "Balancing the Scales of Women’s Lives in the Countdown to 2015", Ottawa, Canada, June 10th-11 2010

Two weeks prior to the G8 and G20 Meetings in Canada, the European Parliamentary Forum on Population and Development (EPF) in co-operation with the Asian Forum of Parliamentarians on Population and Development (AFPPD), the Forum of African and Arab Parliamentarians on Population and Development (FAAPPD) and the Inter-American Parliamentary Group (IAPG) brought over 40 Parliamentarians to the Sixth Annual Summit “Balancing the Scales of Women’s Lives in the Countdown to 2015". The event hosted by Hon. Raymonde Folco, MP, Chair of the Canadian Association of Parliamentarians on Population and Development (CAPPD)  in close cooperation with the Parliamentary Centre addressed MDG targets which have not yet been achieved and specifically examined the theme of Women and Development, based on goals 1, 5 and 6, which deal with the reduction of extreme poverty and hunger, with a specific focus on maternal health, and combating HIV/Aids and other diseases such as malaria and tuberculosis.

Approximately 150 participants took part at the Summit including international and civil society organizations, indigenous organizations from Latin American and the Caribbean and representatives of Canada’s First Nations, Inuit and Métis Peoples.

During the Session 4 - "Dialogue with Donor Countries: How reproductive Health and Family Planning Help Meet all the MDGs, Parliamentarians expressed their views on how to overcome obstacles in policies and funding in the Final Countdown to 2015 and ensuring that the Health MDGs are met.

"Ensuring the coordination with the Governments from the Global South and the dialogue with fellow Parliamentarians and regional Parliamentary Associations will make aid more efficient and targeted", said Hon. Henriette Martinez, MP, France. Baroness Tonge from United Kingdom informed participants that the Maternal and Child Health is the development priority of the UK Government this year. "It is cruel and immoral to prevent women from access to reproductive health and family planning" she said. Hon. Eleni Theocharous, MEP (Cyprus) said that ensuring obligatory blood testing for HIV/AIDS for all in Sub-Saharan Africa would help reduce the pandemic.

Hon. George Tsereteli, MP from Georgia and EPF Vice-President chaired the Session on Best Practices and MDGs from all over the world, where European Representative, Hon. Birute Vesaite, MP Lithuania discussed the necessity of meeting the needs of young people.

Parliamentarians concluded with adopting the Parliamentary Appeal to G8/G20 Heads of State and Governments. Among others, Parliamentarians called on "pooling new funding in a total of 24 billions under an international funding mechanism, specifically for MDG 5, which will provide targeted assistance for sexual and reproductive health and rights, family planning and access to safe abortion, when and where its legal and therapeutic abortion".

 The Appeal was later on submitted to Canada’s Prime Minister, The Right Honourable Stephen Harper, host of the 2010 Heads of State Summits . 

For more information about 6th Annual Parliamentarians’ Summit on "Balancing the Scales of Women’s Lives in the Countdown to 2015", contact Saskia Pfeijffer at saskia@iepfpd.org or Marina Davidashvili at: marina@iepfpd.org

When we speak about universal access to contraceptives and the huge unmet need for family planning services that exists in the world today, the image that usually comes to mind is that of poor women in Africa. Indeed, in most countries, poor women have a much higher rate of unmet need than do women with higher incomes, and in Africa, unmet need for contraception is much higher than in other regions. More than 60 percent of women of reproductive age have an unmet need for contraception in Africa.

What is frequently forgotten though, is that unmet need is high among older adolescents and young adults, and most pronounced among young women 20 to 29 years of age. From any angle we look, young women are at the greatest disadvantage in terms of access to needed services, in Africa and everywhere in the world. An estimated 818 million women worldwide would like to limit childbearing but do not have access to modern contraceptives. Nearly 70 percent of young women in sub-Saharan Africa and an equal share in Southeast and South Central Asia have unmet need for contraception. As a result of this gap, the number of unintended pregnancies and births if very high. Unintended pregnancies contribute to unsafe abortions: Adolescents account for an estimated 2.5 million of the approximately 19 million unsafe abortions that occur annually in the developing world.

These facts should give us reason enough for much greater attention to young women. There are, however, three other reasons that are as or more compelling.

The first is purely demographic: early childbearing contributes to population momentum, the neglected component of population growth.  Population momentum refers to the continued population growth that occurs even after a given population growth has reached replacement-level fertility when there is a high concentration of people in their childbearing years.

In terms of population growth, an exclusive focus on fertility decline is misguided because postponement of childbearing has a significant contribution to the overall rate of growth of a population and the absolute numbers ultimately resulting from that rate of growth.  Those of us coming from a rights-based perspective do not feel very comfortable discussing the demographic issues at hand because of the risk of using “population control” to justify coercive policies.  The fact that a huge number of women do want to space births and limit the ultimate size of their families, though, creates a win-win situation, where fulfilling women’s own expressed needs results in a demographic bonus – not an insignificant consideration in a world increasingly pressured by environmental concerns. In short, getting to a slower rate of growth can be achieved without trampling on individual rights. Quite the opposite: it is better achieved by fulfilling young women’s right to information, to health services and to autonomy regarding the decision on whether and when to have children and how many children to bear.

The second reason why we should pay more attention to young women’s unmet need is that fulfilling their needs has proved more difficult than is the case with older women. Throughout the world, we have seen that in cases where fertility rates have declined substantially among women above 30 years of age, the same has not always happened among younger women despite similar desires to space and limit births .  In fact, the proportion of adolescents who have become mothers in Latin America has actually increased in 14 countries and decreased in only 3 of the 17 countries studied, even when the adolescent fertility rate has slightly decreased due to the fact that there was a decrease in second births.

The explanation for this intractability of unmet need among adolescents rests on a host of different social conditions in different countries. In many societies, lack of educational opportunities and economic inequalities offer few attractive options to girls other than motherhood. This is especially true for girls living in poverty. A substantial proportion of adolescent mothers declare that their pregnancy was desired even though this proportion seems to be decreasing –at least in the countries in Latin America. But an equally substantive proportion –both married and unmarried– wanted to postpone or avoid pregnancy.

A third and pervading factor that affects both wanted and unwanted pregnancies of adolescents in most societies is the basic question of young people’s sexual rights.

This might be surprising because when we think of unmet need the first thing that comes to mind is supply of contraceptives and availability of services. And indeed, they are basic. Without contraceptives, women of any age will – by and large – be unable to realize their own desire to avoid a pregnancy or to limit the size of their families to that desired. The same applies to young women. Married and unmarried adolescents alike need information and access to contraceptive methods so that they can avoid a pregnancy they do not want. But young women face deep social and psychological barriers that older women normally don’t. And they all have their roots in the denial of young women’s sexual rights.

In most societies there is a deep resistance to recognize young people as subject of rights, and an equality strong denial of the recognition of them as sexual beings. The deadly combination of these entrenched values takes different shapes and forms in different cultures and different societies. While in some places young women are forced into early marriages with the expectation that they produce sons whether or not they want to do it, in others good girls are still expected to remain virgins until marriage no matter how late that might occur.

Cultures are rapidly evolving and public policies could successfully address the violation of human rights evident in harmful cultural practices.  However, of greatest concern is that very little public policy support exists for programs that address young people’s sexuality in an evidence-based and non-judgmental way even in societies where enforcement of virginity taboos is rapidly eroding or is no longer as prevalent..  Good quality comprehensive sexuality education is very rarely available in schools, much less for the millions of adolescents who are out of school. Rigorous studies have shown that comprehensive sexuality education works but resources for its large-scale implementation are far from the top of the agenda, even for those trying to address unmet need. Youth friendly services remain a boutique endeavor.

Equally or perhaps even more damaging is the other side of the coin: the feeling of lack of entitlement to education and services among young women. The lack of society’s recognition of their sexual rights and the absence of public policies to fulfill those rights makes it inconceivable for many of them to use services that might be available and used by older women.

So, what is the advocate for meeting the unmet need to do? Push for continuing strong endorsement of the Millennium Development Goal 5 b at all relevant international fora? Yes. Keep adolescent fertility as the most important indicator among those related to 5b? Yes. Advocate for resources earmarked to young women’s services and education? Yes.  Advocate for gender-sensitive comprehensive sexuality education is schools? Yes. Support policies to empower young women economically? Absolutely!  But above all, promote the sexual rights of young women, their full recognition as rights bearers, according to their evolving capacity.

  
http://www.rhrealitycheck.org/blog/2010/06/07/filling-unmet-need-contraception-deliver-women

Is this condom to avoid pregnancy? Or is it to avoid HIV?

That’s the uncomfortable question representatives from the International Planned Parenthood Federation have sometimes had to ask in clinics in developing countries.

The question is a throwback to the George W. Bush-era rule that wouldn’t allow any US aid money to pay for contraceptives. US President Barack Obama quickly changed the policy when he took office.

“While this may sound ludicrous, IPPF has before been in the position where, in the clinic, we have to ask clients if they want they want the condom for pregnancy or STI prevention,” read Jolanta Scott-Parker in a statement written by IPPF.

“This is because the donor for the former was a European community and the latter was the United States government. Not only is this invasive and confusing for clients, but it also precludes dual protection if we run out of the family planning condoms.”

Scott-Parker, from the Canadian Federation for Sexual Health, was one of several international development group representatives who spoke about maternal and child health at the House Foreign Affairs Committee on Tuesday.  She read the statement for IPPF because IPPF spokesman Pierre LaRamée’s flight to Ottawa was cancelled.

LaRamée took aim at the shape he sees the G8 maternal and child health initiative taking. The only detail the government has so far released is the lack of abortion funding, so nobody really knows yet how it will look. But based on statements by International Cooperation Minister Bev Oda and Prime Minister Stephen Harper, La Ramée is guessing it will be a menu-style plan, where countries select the services they want to provide. He says that risks leaving critical areas of women’s health unfunded, undermining health systems and putting women’s lives at risk.

“Do we really want to see a maternal health initiative that provides a woman with clean water and better nutrition only to fail to provide the help she needs preventing an unwanted pregnancy or preventing a sexually-transmitted infection, including HIV?” he wrote.

IPPF is still waiting to hear whether CIDA will renew their funding for 2010-2012.

http://www.torontosun.com/blogs/thehill/2010/06/01/14218016.html