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    FDA could approve over-the-counter purchase of first birth control pill

    FDA could approve over-the-counter purchase of first birth control pillThe agency is considering the application by HRA Pharma to make Opill available without a prescription The Food and Drug Administration will consider an application for the first birth control pill to be sold without a prescription.US pharmacies reportedly set purchase limit on emergency contraception pillsRead moreThe application from HRA Pharma would seek to make Opill – an every day, prescription-only hormonal contraception first approved in 1973 – available over-the-counter. Such an approval from the FDA would allow people to purchase “the pill” without a prescription for the first time since oral contraceptives became widely available in the 1960s.The application will also cast oral contraceptives into a fraught political moment in the US. The US supreme court ended federal protection for abortion rights late last month, throwing into question the future of birth control.The drugmaker said the timing is unrelated. A decision on the application could come as soon as 2023.“This historic application marks a groundbreaking moment in contraceptive access and reproductive equity in the US,” said HRA Pharma’s chief strategic operations and innovation officer, Frédérique Welgryn. “More than 60 years ago, prescription birth control pills in the US empowered women to plan if and when they want to get pregnant.”Making birth control available without a prescription will “help even more women and people access contraception without facing unnecessary barriers”, said Welgryn, whose company has already submitted the application.Most oral contraceptives are exceedingly safe, using a combination of estrogen and progestin to prevent pregnancy. Opill uses only progestin, which may make it a better candidate for over-the-counter marketing, since it can be used even by people with a history of blood clotting or uncontrolled high blood pressure, according to the American College of Obstetricians and Gynecologists (ACOG).However, the “mini-pill,” as some progestin-only contraceptives are called, also has side effects. The most common is breakthrough bleeding between periods, which can be unpredictable, according to ACOG.Presently, all hormonal daily birth control pills require a prescription in the US, and many are covered by health insurance. However, obtaining such a prescription has been difficult for many US women. Roughly one-in-four women who had ever attempted to get a hormonal birth control prescription reported difficulty doing so, often because of language barriers, lack of insurance or cost, according to a 2015 study.If approved, over-the-counter birth control would be a victory years in the making. The Free the Pill Coalition has worked to make birth control available without a prescription for nearly two decades in the US, saying it is now available without a prescription in more than 100 countries. The American Medical Association, which is the nation’s largest professional association of doctors, said in June it supports over-the-counter birth control.Over-the-counter birth control would also provide an alternative form of family planning in the chaotic aftermath of the supreme court’s decision to overturn its landmark 1973 ruling in Roe v Wade, which granted federal abortion protections.Several states have already begun to enforce near-total abortion bans, and that number is expected to grow to at least 26 in the coming weeks.The debate about abortion rights could spill over into the FDA’s work on contraception. Already, contraception is among the most politicized aspects of the agency’s work. Emergency contraception, sold under the brand name “Plan B” in the US, is already available over-the-counter. The FDA recently said medication to terminate a pregnancy, often called the “abortion pill” or “medication abortion,” can be prescribed via telemedicine.However, states hostile to abortion and anti-abortion groups have already signaled that medication abortion is the next battleground for clamping down on abortion rights. That could put the FDA and states into direct conflict as states seek to regulate a medication that was federally approved.That conflict is likely to be sorted out in court. Should it reach the supreme court, the battle between the FDA and states could come before a conservative supermajority, some members of which have already expressed a willingness to overturn federal rights to contraceptives and to re-evaluate the power of federal agencies to regulate states.TopicsUS newsContraception and family planningUS politicsHealthReuse this content More

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    Biden move to refund UN population agency is 'ray of hope for millions'

    The decision by US president Joe Biden to refund the UN population fund, UNFPA, offers “a ray of hope for millions of people around the world”, said the agency’s executive director.
    Dr Natalia Kanem said the announcement on Thursday would have an “enormous” impact on the agency’s work, particularly as the world continues to grapple with the coronavirus pandemic.
    In 2017, the Trump administration halted funding to the UNFPA, claiming it supported coercive abortion and involuntary sterilisation – claims strongly denied by the agency.
    The US was one of the agency’s largest funders. In 2016, it provided $69m (£50m) to support its work in more than 150 countries.
    “Ending funding to UNFPA has become a political football, far removed from the tragic reality it leads to on the ground. Women’s bodies are not political bargaining chips, and their right to plan their pregnancies, give birth safely and live free from violence should be something we can all agree on,” said Kanem.
    She added that the pandemic had hit particularly hard the vulnerable communities in which the UNFPA works. “US support will be instrumental in helping us build back better and fairer.”
    US secretary of state Antony Blinken said his department would appropriate $32.5m to support the UNFPA this year.
    “UNFPA’s work is essential to the health and wellbeing of women around the world and directly supports the safety and prosperity of communities around the globe, especially in the context of the global Covid-19 pandemic,” he said.
    Blinken also confirmed that the US would withdraw its support for the “Geneva Consensus Declaration” – an anti-abortion policy introduced last year by the then secretary of state Mike Pompeo, and signed by more than 30 countries, including Brazil, Hungary and Uganda.
    “The United States is re-engaging multilaterally to protect and promote the human rights of all women and girls, consistent with the longstanding global consensus on gender equality and sexual and reproductive health and reproductive rights,” said Blinken. More

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    Joe Biden axes 'global gag rule' but health groups call on him to go further

    Health groups around the world are celebrating the end of a harmful policy banning US funding for overseas aid organisations that facilitate or promote abortion, which was scrapped by the US president, Joe Biden, in a presidential memorandum on Thursday.Reproductive rights advocates are urging the new administration to now go further and permanently repeal the Mexico City policy – known as the “global gag rule” – to prevent it being reinstated by a future Republican president. The policy has been blamed for contributing to thousands of maternal deaths in the developing world over the past four years.The gag rule prevents overseas organisations that receive American aid from using their own money to provide information about abortion, or carry out abortions. First adopted by the Reagan administration in 1984, it has been repealed by every Democratic administration and reinstated by every Republican one in the years since.In a short appearance in the Oval Office on Thursday afternoon, Biden said he ended the policy as part of an effort to “protect women’s health at home and abroad”.But Donald Trump went further than previous Republican presidents. The policy usually applies to family planning organisations. But the Trump administration expanded the policy to include all global health programmes, including programmes that address HIV, nutrition, malaria and cholera.Widening the rule increased the pool of aid funds it affected from roughly $600m to about $12bn (£8.7bn), according to the Guttmacher Institute, a health policy research group.“We can breathe,” said Serra Sippel, the president of the Center for Health and Gender Equity, of Biden’s plans to repeal the policy. “There’s just so much hope and optimism in Washington DC right now. We have a lot of work to do, but it’s so much better.”The consequences of Thursday’s memorandum will ripple out from Washington into more than 70 countries including some of the poorest places in the world, where essential women’s health operations were abruptly halted or scaled down after Trump reinstated the rule in January 2017.In Zimbabwe, a women’s health team run by Abebe Shibru, from the organisation MSI Reproductive Choices, cut its operations by 60%. “We reduced our outreach from 700,000 women to about 300,000,” Shibru, who now heads the organisation’s Ethiopian operations, told the Guardian.“Women missed out on information, they had no access to family planning, and in return they were exposed to unintended pregnancy and unsafe abortion, which contributed to higher maternal mortality.”Zimbabwe’s teenage pregnancy rate increased by 2% over the past four years, according to Unicef data, a trend Shibru said was exacerbated by cuts as a result of the gag rule.“We were not providing services to rural women, so they had no choice but to get pregnant against their wish,” he said.Pledging conferences attracted hundreds of millions of dollars in donations from governments and private groups to try to bridge the gap in American funding, but could not meet the total shortfall.An assessment of the rule’s impact released last year, surveying health organisations in Nigeria, Kenya, South Africa and Nepal, found a sector in “crisis” with confusion over what was banned and permitted using US aid, a growing stigma around reproductive health services and widespread closures and scaling downs of programmes.Trump’s ban also spawned a new wave of activism, including a new grassroots movement, SheDecides, which is pressuring policymakers around the world to commit to upholding reproductive and sexual health rights.Zara Ahmed, the associate director of federal issues at the Guttmacher Institute, said repealing the gag rule “is just the first step in undoing [the US’s] current status as the greatest global hindrance to reproductive health”.“We are glad that the Biden-Harris administration is addressing the global gag rule …… But let’s be clear, repealing the global gag rule is the bare minimum this administration can do to address the harm caused by the previous administration’s coercive and spiteful approach to foreign policy,” she said.“The Biden-Harris administration can, and must, take a comprehensive approach to unravelling the dangerous, punitive and coercive policies the outgoing administration has woven into our foreign policy, and it must take action to address longstanding harmful policies like the Helms amendment.”The Helms amendment has been widely misinterpreted as a total ban on US funding used for abortion overseas, when in fact it can be used to support abortion in cases of rape, incest or a woman’s life being in danger. A bill to permanently repeal it was introduced last year.On Thursday, the Global Health, Empowerment and Rights Act (Global HER Act) to permanently repeal the global gag rule will be introduced for the third time in Congress. The bill, cosponsored by the new vice-president, Kamala Harris, has received cross-party support, and hopes are high it will pass.“It’s not automatic and it’s not going to be easy but we’re starting in a very strong place to get the act passed,” said Sippel. “If not the bill itself, but the language of the bill incorporated into another bill. Getting rid of the GGR, that’s what we’re striving for.”Sippel also called on the Biden administration to disavow the “Geneva consensus declaration” – an anti-abortion policy Trump promoted last year – to “signal to the world that abortion and LGBTQ rights and sexual and reproductive rights are important, and to state that loudly to the world”.She added that some activists wanted the Biden administration to issue a formal apology for US policies on sexual and reproductive health and rights over the past four years.Biden also ordered funding restored to the UN population fund, UNFPA, which Trump stopped.The agency’s executive director, Natalia Kanem, hailed the “enormous” impact of the decision.“Ending funding to UNFPA has become a political football, far removed from the tragic reality it leads to on the ground. Women’s bodies are not political bargaining chips, and their right to plan their pregnancies, give birth safely and live free from violence should be something we can all agree on,” she said. More

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    Who is Amy Coney Barrett? Trump's anti-abortion supreme court nominee

    Subject to confirmation by the Senate, Amy Coney Barrett will be the youngest justice on the US supreme court, a position from which she will be set to influence American life for decades yet to come.Donald Trump’s nomination of the 48-year-old comes two years after her name surfaced as a possible replacement for the retiring Anthony Kennedy, whose seat was ultimately filled by Brett Kavanaugh after contentious confirmation hearings.Republicans want Barrett confirmed before the presidential election, on 3 November. Democrats lack the power to block her but the process is likely to be no less contentious than that which Kavanaugh survived.To the fore is Barrett’s religious faith, prominently her association with People of Praise, a charismatic Christian group with what is described as an authoritarian internal structure.Arguments from both political factions have been publicly rehearsed: will Barrett’s religious convictions affect her performance as a supreme court justice, or should they have nothing to do with determining her fitness for such an important role?Conservatives argue public questions about religious beliefs should be excluded. Liberals suggest Barrett’s beliefs could overshadow her ability to administer unconflicted jurisprudence on issues such as abortion and contraception, thereby threatening foundational values of religious liberty.Barrett clerked for the late conservative justice Antonin Scalia, who argued that there is no constitutional right to abortion. The gravest threat Barrett poses, according to many on the left, is to Roe v Wade, the 1973 ruling that ensured abortion rights.In 2017, Trump nominated the Louisiana native and Notre Dame Law School graduate to the Chicago-based seventh US circuit court of appeals.Answering a White House questionnaire, the mother of seven – who adopted two children from Haiti – said she admired justice Elena Kagan, an Obama-appointed abortion rights supporter, for bringing “the knowledge and skill she acquired as an academic to the practical resolution of disputes”.But during her confirmation hearing, Democratic senator Dianne Feinstein memorably said Barrett had “a long history of believing that your religious beliefs should prevail” and added”: “The dogma lives loudly in you.”Barrett has said she is a “faithful Catholic” but her religious beliefs do not “bear in the discharge of my duties as a judge”. She has also said legal careers ought not to be seen as means of gaining satisfaction, prestige or money, but rather “as a means to the end of serving God”.People of Praise, the group to which Barrett belongs, emerged out of the revivalist movement of the 1960s, which blended Catholicism and Protestant Pentecostalism. Founded in South Bend, Indiana, in 1971 and with 1,700 members, the group describes itself as a community that “support[s] each other financially and materially and spiritually”.“Our covenant is neither an oath nor a vow, but it is an important personal commitment,” it says on its website. “Members should always follow their consciences, as formed by the light of reason, and by the experience and the teachings of their churches.”There’s nothing particularly extreme about People of Praise – other than women are not given senior positionsWilliam CashOn Saturday William Cash, chairman of the Catholic Herald, told the Guardian members of People of Praise were on “the conservative side of the church and are unlikely to be the sort of progressives who are fanatical about Pope Francis”.“There’s nothing particularly extreme about People of Praise – other than it is very hierarchical and women are not given senior positions,” he said.The former reporter saw questions about Barrett’s Catholicism and the supreme court in the context of the White House race.“Not only is Biden Catholic, albeit in a very liberal way that will alienate many ‘trads’,” Cash said, “but Melania Trump is also a practicing Catholic and has even had a private audience with Pope Francis in Rome, describing it as one of the most important moments of her life. So Melania, Amy Coney Barrett and Biden are from opposite poles of the US Catholic planet.”Former members of People of Praise and religious scholars have described an organization that appears to dominate some members’ everyday lives, in which so-called “heads”, or spiritual advisers, oversee major decisions. Married women count their husbands as their “heads” and members are expected to tithe 5% of their income to the organization.According to a former member, Adrian Reimers, “all one’s decisions and dealings become the concern of one’s ‘head’, and in turn potentially become known to the leadership”.Heidi Schlumpf, a national correspondent for National Catholic Reporter, called the group’s level of secrecy “concerning”.Trump may sense in Barrett’s nomination a last chance to energise religious conservatives in his race for re-election. The president met evangelical leaders at the White House before introducing Barrett to the press.In 2012, as a professor at Notre Dame, Barrett signed a letter attacking a provision of the Affordable Care Act, the healthcare reform known as Obamacare, that forced insurance companies to offer coverage for contraception, a facet of the law later modified for religious institutions.Republican attempts to bring down the ACA have repeatedly fallen short. If Barrett is confirmed before the November election, one of her first cases shortly after it could determine its fate. More