FDA Should Act Quickly to Approve New Emergency Contraceptive

Alicia Johnson

The FDA is considering approval of a new pregnancy prevention option.  Anti-choicers are, unsurprisingly, opposing approval of and expanded access to the method.

Today the Food and Drug Administration (FDA) Advisory Committee for Reproductive Health Drugs will meet to advise the FDA on the approval of a new emergency contraceptive, ulipristal acetate 30 mg, also known as “ella” in the United States. It has been available under the brand name ellaOne® in Europe since May 2009 after approval from the European Medicines Agency and is now available in more than 20 countries.  Clinical trial data has shown ella to be safe and effective at reducing the risk of pregnancy up to five days (120 hours) after unprotected intercourse or contraceptive failure. This is two days more than other products on the market, providing women an even longer window to prevent pregnancy after unprotected sex.

As a reproductive health advocate, I am excited for the opportunity to expand safe and effective pregnancy prevention options for women. Half of all pregnancies in the United States are unplanned. While there are many birth control options to choose from, sometimes a woman needs a backup method – a condom breaks or she forgets to take her pill. There are also cases when sex is unplanned, or unfortunately, unwanted. Emergency contraception is an important tool for a woman to tailor family planning for her particular circumstances.

Ella is a welcome addition to the contraceptive family for two key reasons. First, it may be a more affordable EC option. If a woman’s insurance doesn’t cover over-the-counter EC, the availability of ella, which if approved will be a prescription-only product, may help her utilize EC in the event she needs it. Second, because ella remains effective for five days, its availability will increase access for women who need additional time to obtain the product.

Unfortunately, recent media coverage has highlighted how opponents of ella are working to demonize this safe, effective and necessary contraceptive option out of the gate, leading again to the unnecessary politicization of women’s reproductive health. Opponents are predictably rehashing the same, tired arguments against emergency contraception used in the past, attempting to create confusion and doubt about this product. While chemically related to mifepristone, there is no evidence that ulipristal acetate 30 mg can cause an abortion. Women seeking to end a pregnancy should use one of the other safe, legal FDA approved options. Other sources, including Feministing and Salon’s Broadsheet, have highlighted the potential of ella for women’s health. 

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In written and oral testimony this Thursday, women’s reproductive health organizations will urge the FDA to approve this important new EC option.  We will remind the FDA Advisory Committee of the importance of expanding safe and effective pregnancy prevention options for women, and the significance of the increased window of time ella provides for a woman seeking to prevent pregnancy after contraceptive failure or unprotected intercourse. A woman is healthiest when she can decide the timing and spacing of her pregnancies.  Let’s ensure that women have access to the most safe and effective options for preventing pregnancy.

For more information on ella, check out the comprehensive fact sheets released by Reproductive Health Technologies Project and Planned Parenthood.

News Contraception

New Hawaii Law Requires Insurers to Cover a Year’s Supply of Birth Control

Nicole Knight Shine

Insurance companies typically cover only a 30-to-90-day supply of birth control, posing a logistical hurdle for individuals who may live miles away from the nearest pharmacy, and potentially causing some using oral contraceptives to skip pills.

Private and public health insurance must cover up to a year’s supply of birth control under a new Hawaii law that advocates called the nation’s “strongest.”

The measuresigned by state Gov. David Ige (D) on Tuesday, applies to all FDA-approved contraceptive medications and devices.

Hawaii joins Washington, D.C., which also requires public and private insurers to cover up to 12 months of birth control at a time.

Oregon passed a similar measure in 2015, but that law requires patients to obtain an initial three-month supply of contraception before individuals can receive the full 12-month supply—which the Hawaii policy does not.

“At a time when politicians nationwide are chipping away at reproductive health care access, Hawaii is bucking the trend and setting a confident example of what states can do to actually improve access,” Laurie Field, Hawaii legislative director for Planned Parenthood Votes Northwest and Hawaii, said in a statement.

Insurance companies typically cover only a 30-to-90-day supply of birth control, posing a logistical hurdle for individuals who may live miles away from the nearest pharmacy, and potentially causing some using oral contraceptives to skip pills. Both the American Congress of Obstetricians and Gynecologists (ACOG) and the U.S. Centers for Disease Control and Prevention recommend supplying up to one year of oral contraceptives at a time, as the Hawaii Senate Committee on Commerce, Consumer Protection, and Health noted in a 2016 conference report.

Fifty-sex percent of pregnancies in Hawaii are unintended, compared to the national average of 45 percent, according to figures from the Guttmacher Institute.

Women who received a year’s supply of birth control were about a third less likely to experience an unplanned pregnancy and were 46 percent less likely to have an abortion, compared to those receiving a one- or three-month supply, according to a 2011 study of 84,401 California women published in Obstetrics and Gynecology.

Reproductive rights advocates had championed the legislation, which was also backed by ACOG–Hawaii Section, the Hawaii Medical Association, and the Hawaii Public Health Association, among other medical groups.

“Everyone deserves affordable and accessible birth control that works for us, regardless of income or type of insurance,” Planned Parenthood’s Field said in her statement.

Commentary Contraception

Zika Threat Shows Urgent Need for Better Contraceptive Access

Julie Rabinovitz

As summer approaches and global officials continue to issue warnings about Zika, U.S. federal and state officials can allocate funds and expand insurance coverage to ensure contraceptive access.

Pressure is mounting on Congress to send President Obama a sufficient spending bill to combat the Zika virus’ spread.

The House and Senate recently passed their own measures, both proposing less than the $1.9 billion the president requested. But now they must work out their differences for the sake of our public health. Currently, none of these proposals include funding for Title X, the federal program that provides low-income people with family planning services, birth control, and other preventive reproductive health services. With the potentially life-changing outcomes that can result from contracting Zika, federal and state action is urgently needed to support prevention efforts and increase access to the full range of contraception available nationwide.

There’s no time to waste. More than 600 people in the continental United States, including at least 150 pregnant women, have already been infected with Zika. This month, a New Jersey infant exposed to Zika was born with the birth defect microcephaly, where a baby’s head is smaller than expected. Many more Americans have been affected in Puerto Rico and other U.S. territories. Local transmission is expected to spike as warmer weather approaches and climate conditions become more favorable to the virus’s primary vector, the Aedes aegypti mosquito.

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The Centers for Disease Control and Prevention (CDC) have reported significant evidence showing links between Zika and adverse pregnancy and birth outcomes, including miscarriage, stillbirth, and fetal abnormalities. Brain damage in Zika-infected babies is proving to be far worse than doctors initially thought. Zika has been found to attack lobes of the fetal brain that control thought, vision, and movement. Exposure to Zika was first considered to be a threat for women in the first trimester only, but there is growing concern about the possibility of maternal-fetal transmission throughout pregnancy.

It has also been discovered that men infected with Zika can transmit the virus to their sexual partners through semen, where the virus is stored much longer than in the blood.

As more individuals learn about the potential health risks linked to the virus, many will want and need services and information to help them effectively avoid or postpone pregnancy. Extensive research already shows the public health value and taxpayer savings associated with preventing unintended pregnancy.

Now with Zika, the stakes are even higher.

Congressional leaders must act without delay to pass a comprehensive Zika funding and preparedness package that includes additional resources for Title X to expand access to reliable birth control, related services, and counseling to low-income and uninsured people. Increased funding for these essential services is needed on the ground now, especially in regions expected to be disproportionately affected by the virus. The threat is particularly worrisome in areas that experience the warmer weather that’s conducive to Zika-carrying mosquitoes.

On the state level, elected leaders across the country should require public and commercial health plans to cover all—not just some—FDA-approved birth control. After the passage of the Affordable Care Act (ACA), California was one of the first states to approve a contraceptive-coverage equity law that codified the spirit of the ACA’s contraceptive mandate, also known as the birth control benefit, by requiring health plans to cover all methods of contraception without cost sharing or restrictions. Maryland recently enacted a similar measure that also requires coverage for vasectomies, and several other states are considering legislation with the same intent. The Zika threat makes passage of these kinds of laws across the country time-sensitive. State Medicaid programs must also adopt reimbursement and coverage policies that break down barriers enrollees may face in accessing the full range of effective contraceptive methods.

Patients must be able to get the method they can use safely and consistently. That means health-care professionals across the country, including those in primary-care settings, must offer all forms of available birth control. Providers need training to support their patients in accessing the contraceptive method that is best suited for their health and reproductive life goals. Even some OB-GYNs can use training on newer methods and updated best practices.

Many unknowns remain regarding the Zika virus, which has quickly become one of the world’s greatest public health challenges. But a concerted and proactive response—that includes improved access to contraception—must be implemented before Zika becomes a national public health crisis here in the United States.