Articles about Emergency Contraception
(Washington, DC) – Nov. 13, 2014 – On October 31, 2014, Amazon.com, the world’s largest online retailer, abruptly and without explanation, halted sales of the most affordable brand of emergency contraception (EC), AfterPill. Amazon routinely sells hundreds of over-the-counter drugs, yet the company has frequently impeded online sales of AfterPill, despite its safety and over-the-counter (i.e., nonprescription) status. Though Amazon has consistently sold the brand name EC pill, Plan B One-Step, AfterPill’s lower cost may make it a preferable choice for customers (approximately $35.00 without shipping for Plan B One-Step compared to $25.00 without shipping for AfterPill).
Hoping to put pressure on the retailer, AfterPill went public with its struggle on November 11. AfterPill’s statement spurred reproductive health advocates to action, as groups and individuals blasted Amazon with emails, signed petitions, and took to social media to spread the word. Facing tremendous backlash for its decision, Amazon reinstated sales of AfterPill on November 13.
“Initially, women’s access to EC was blocked by politics, but these days, one of the largest barriers is cost. It is absolutely essential that competition among EC products be allowed to thrive in order to create market pressures to reduce the price of EC and make it affordable for women of all income levels,” said Jessica Arons, President and CEO of the Reproductive Health Technologies Project (RHTP). Arons also praised the quick work of the reproductive health community: “Amazon’s decision to restock AfterPill is a victory and a testament to what can be accomplished when advocates mobilize.”
Because EC’s efficacy depends on how soon it is taken after a contraceptive failure or unprotected sex, it is crucial that women have unobstructed access to EC. Online sales of EC are especially important given that online shopping is increasingly popular and provides greater privacy and that customers in rural or low-income communities may have limited access to EC at brick-and-mortar pharmacies.
For more information about EC, please visit RHTP’s website.
IN RESPONSE TO THIS ARTICLE.
Statement from HRA Pharma – Levonorgestrel EC label change
The effect of a women’s weight on levonorgestrel efficacy was first identified in 2011 during the development of an alternative emergency contraceptive product in the context of a clinical trial. As a result, HRA Pharma performed further analyses in 2012, which enabled it to put together a safety variation which was presented to European regulatory authorities at the start of 2013. By sharing the data in this manner, it demonstrates a clear obligation by the company to be transparent with the healthcare community and provide regulators with the most up-to-date information to inform women.
European authorities involved in the process decided to include the following statement in the levonorgestrel labeling: ?”In clinical trials, contraceptive efficacy was reduced in women weighing 75 kg or more and levonorgestrel was not effective in women who weighed more than 80 kg.”
HRA Pharma does not market levonorgestrel in the US, and is thus not involved in any process of label change for levonorgestrel in the US.
HRA Pharma recommends that women affected by the change in labeling be advised to discuss alternative emergency contraceptive options (IUD or alternative oral EC) with their doctor or pharmacist.
Chief Executive Officer
Redux – The personal is political
Teaching children to understand and cope with bullies is essential, but bullying isn’t limited to elementary school. Bullying may not be physical or direct. It is persistent, intimidating, and it flourishes when victims and witnesses are afraid to speak up or speak out. It is time to identify reproductive coercion for what it is and call the bullies what they are.
“Reproductive coercion” includes sabotage of birth control by abusive partners and occurs in all social and economic groups and most frequently to unmarried sexually active women. Male partners seek control over their partner’s reproductive options, even whether and when to have sex, to assert and maintain power.
Just as the pattern of intimidation, harassment, aggression and control is not limited to schools, reproductive coercion is not limited to interpersonal relations. It is ubiquitous at public forums, health care settings, legislative discourse, and campaign politics. This bullying is intended to intimidate, to silence people who disagree, to deny people access to health care they want or need, to pass legislation that denies reproductive justice, and to maintain power by opposing reproductive rights and justice.
Last week, one of Family Planning Health Services’ (FPHS) employees was participating in a health fair sponsored by our local United Way and county health department. It happened to be hosted at a Catholic hospital. One of the medical directors required the employee to remove information on emergency contraception. The doctor then used post-it notes to obscure “prescription contraception” and “non-prescription contraception” on the FPHS display.
The hospital has been recognized for its work with sexual assault victims and the hospital president is on the state attorney general’s sexual assault task force. We can assume the hospital is in compliance with state law to provide emergency contraception in the emergency room and we know that many of the physicians provide prescription and non-prescription contraception to their patients. But, like the classic elementary school bully, the physician used position and status to censor and deny information to participants.
Victims and bystanders might excuse the bully; “I should have known this would provoke him,” or “I should have known better than to be in this neighborhood,” but motivation does not excuse intimidation, bullying and harassment. On a public level we may understand religious objections, but using status, position, power, volume or force to control someone else’s reproductive health and behavior must be challenged and condemned if the culture of sexual coercion is to change.
Several days ago, Wisconsin’s State Senator Mike Ellis used the power of the majority and the gavel to silence debate and fast-track a bill that requires women to undergo a medically unnecessary ultrasound procedure and morality message before they can have an abortion. In our state assembly, our state representative shared her experience as a child rape victim and spoke very personally to how she felt as a victim and as the mother of three daughters, to a law requiring victims to undergo a re-invasion of privacy and self-control. On-line bullies vilified and harassed her for speaking out as a victim against the “pro-life” legislation.
There are self-styled “prayer warriors” standing outside our family planning clinics for a few months each year. They know that many of our patients and WIC participants/children are intimidated by their presence, but they justify the bullying on the basis of their religious beliefs about abortion, which we do not provide.
Victims and witnesses to reproductive coercion, intimidation and bullying must try to speak up, seek help, or intervene as the situation requires. When it comes to public and political behavior, calling reproductive coercion what it is the first step to ending it.
President Obama recently reassured women’s rights advocates: “As long as . . . we’ve got to fight to protect a woman’s right to make her own choices about her own health, I want you to know that you’ve got a president who’s going to be right there with you.” Right now, he seems to be in both corners of the ring.
In this corner
Under federal court order the Food and Drug Administration (FDA) was to make Plan B™ available over the counter without age or prescription restriction by May 10th. (Plan B™ is a pill taken as soon as possible and up to 120 hours after unprotected sex to prevent a pregnancy.)
The FDA had determined Plan B ™ to be safe over the counter (OTC) for all girls and women at risk of unwanted pregnancy. In what appears to be an attempt to evade the court order, the Whitehouse engineered an FDA compromise requiring women to show identification and proof of age (15) before they can purchase Plan B™.
Judge Edward Korman sharply denied the Department of Justice (DOJ) request for a stay of his order. He said that the DOJ’s arguments on EC contradict the FDA’s own recommendations and he pointed out the administration’s inconsistency in its positions that requirements for photo IDs are unconstitutional barriers to voting rights, but photo IDs are acceptable for women who need to exercise their reproductive rights.
And in this corner
Meanwhile, half the country away in Denver, the DOJ is defending policy that health insurance should include preventive coverage, including hormonal contraceptives and emergency contraception, without copays or deductibles. Consistent with President Obama’s 2009 directive that political officials should not influence scientific findings and conclusions, he commissioned the National Institute of Medicine (IOM) to make recommendations on prevention for women’s health. In stark contrast to the Plan B ™ FDA case, the President implemented the IOM recommendations and is vigorously defending policies to give women access to EC and other contraceptives against secular corporations such as Hobby Lobby which are claiming a religious exemption so they can deny employees reproductive health coverage guaranteed to others.
When the DOJ asserted “public interest” to Judge Korman, he invited them to explain what public interest is served by unplanned pregnancies and abortions. That is the standard by which this dispute should be decided. No public interest is served by unplanned pregnancies. Which policy best prevents them?
- Unwanted pregnancies – like unplanned and involuntary sex — are more likely to occur to teens, to present higher medical risks, and are more likely to be terminated.
- Judge Korman’s comparison between reproductive rights and voting rights is important because pregnant teens and low-income minorities have the fewest resources to overcome obstacles placed in their way. Those same women and girls also have the greatest difficulty overcoming the health and social consequences of an unplanned pregnancy.
- For almost ten years, FPHS has dispensed 10,000 cycles of EC to our patients — quickly, confidentially, and at low or no cost. We have seen our unplanned pregnancy rate drop. We have identified the greatest obstacles to effective emergency contraceptive use are cost and a lack of accurate knowledge about how it works and when to take it. OTC status is an inadequate and imperfect solution, but adding unnecessary photo ID requirements only amplifies its imperfections.
The Obama administration’s now repeated politicization of the EC issue, in contrast to the Obama administration’s defense of contraceptive coverage in primary care, adds to the stigma and enables the opponents of contraception in their efforts to misinform.
It is unclear in its fight against itself, what the Whitehouse will win, but in the fight to prevent unplanned pregnancies and abortions, it is too clear what women and girls might lose.
The US Food and Drug Administration announced that it would AGAIN go against the courts ruling, and limit the access to Plan B emergency contraception to people ages 15 and up, with proper ID shown at check out. Judge Edward R. Korman, of the U. S. District Court for the Eastern District of New York ruled in Tummino v. Hamburg, that Emergency Contraception (EC) “should be available without a prescription for any age or point-of-sale restrictions within 30 days”.
The legal battle surrounding Plan B has gone on for over a decade, and extended through two Presidencies. Judge Korman’s ruling was issued in response to the Center for Reproductive Rights’ (CRR) renewed lawsuit against the FDA seeking to expand over-the-counter access for all women to all brands of the morning-after pill, including Plan B One-Step and Next Choice. The CRR again filed suit against the FDA when Kathleen Sebelius, secretary of the Department of Health and Human Services, overruled a 2011 FDA decision to make emergency contraception available over-the-counter to all ages.
Lon Newman, Executive Director of Family Planning Health Services, Inc states, “Young teenagers are most at risk of rape and most likely to engage in unplanned unprotected sex. They are also most likely to be afraid to purchase emergency contraception when they have to show identification and they are least likely to have it.
FPHS will continue our efforts to make EC quickly and confidentially available to teens and adults who want to prevent a pregnancy. We will also continue to support health care policy based on medical science and evidence and not on politics or ideology . . . apparently, in this case, that will be contrary to the White House’s position.
The primary obstacles to emergency contraception are lack of knowledge and cost. Neither of those obstacles are changed because of over-the-counter status. However, the Obama administration’s now repeated politicization of this issue for insupportable reasons, only adds to the stigma and misunderstandings surrounding this safe and vital service that safely reduces pregnancies and prevents abortions.”
[From Pam Belluck at the Ny Times]
The Food and Drug Administration said Tuesday that it would make the most widely known morning-after pill available without a prescription to girls and women ages 15 and older, and also make the pill available on drugstore shelves, instead of keeping it locked up behind pharmacy counters.
Until this decision the pill, Plan B One-Step, which is used after sexual intercourse to help prevent pregnancy, was available without a prescription only for ages 17 and older.
The decision did not address a federal judge’s ruling in early April that gave the drug agency 30 days to make the pill available for all ages without a prescription. In a scathing opinion handed down three weeks ago, Judge Edward R. Korman in the Eastern District of New York said the Obama administration had put politics before science in restricting access to the drug.
The F.D.A. and the White House said Tuesday that the Department of Justice was still deciding whether to appeal the ruling, something it can do independently of the drug agency’s decision on Tuesday.
That decision, which takes effect immediately, represents a compromise on the politically charged issue of access to emergency contraception, which has pitted conservative and anti-abortion groups against advocates for women’s health and reproductive rights.
The Justice Department is most likely weighing not only the substance of the judge’s ruling, but also the precedent the ruling would set in countermanding an order by a White House cabinet member, Kathleen Sebelius, the secretary of health and human services. In 2011, she decided the pill would be available without prescription only to those 17 and older, despite the F.D.A.’s finding that it was safe and effective and should be available without any age restrictions. She said the pill had not been studied for safety in girls as young as 11. It was the first time the F.D.A. had been publicly overruled by a cabinet secretary.
After her order, the pill’s manufacturer submitted an amended application seeking access for 15-year-olds. On Tuesday, a Health and Human Services Department official said that Ms. Sebelius was comfortable with the F.D.A.’s decision to approve that application.
Besides lowering the age restriction, the new rule addresses concerns of women who were unable to get the pill if their drugstore’s pharmacy counter happened to be closed. Now, Plan B One-Step will be available in drugstore aisles where family planning or women’s health products are displayed.
The packaging will include a product code that, when scanned by a cashier, will indicate that the customer’s proof of age is required. To try to prevent theft, the manufacturer, Teva Pharmaceuticals, has arranged for each box to have a security tag, the drug agency said.
Margaret A. Hamburg, the F.D.A. commissioner, said in a statement that data proved that 15-year-olds “were able to understand how Plan B One-Step works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease.”
The agency’s decision applies only to Plan B One-Step, which is a one-pill dose, not to the two-pill generic versions, because there is not enough data to show the two-dose versions can be used responsibly by younger teenagers without the intervention of a health provider, said an F.D.A. spokeswoman, Erica Jefferson.
Marty Berndt, a vice president and general manager for Teva, called the agency’s decision “a significant milestone for women.”
But it did not completely satisfy either side of the emergency contraception debate. Anna Higgins, the director of the Center for Human Dignity at the Family Research Council, accused the administration of trying to “placate both sides,” adding that “allowing this to young teens will be something that we will remain very concerned about.”
Cecile Richards, president of Planned Parenthood, called the decision “an important step forward” because it “will eliminate some of the biggest barriers and hurdles that women face in getting emergency contraception.”
But Nancy Northup, president of the Center for Reproductive Rights, which filed the lawsuit that Judge Korman ruled on, said the decision on Tuesday was unsatisfactory.
“We will continue our battle in court to remove these arbitrary restrictions on emergency contraception for all women,” she said.
[Jodi Jacobs0n of RH Reality Check wrote this today]
Today, in a proposal that can best be described as adding insult to injury, the Food and Drug Administration (FDA) approved making emergency contraception (EC) available over-the-counter for teens and women ages 15 and up. This convoluted proposal from the Obama administration comes despite a court order in early April by U.S. District Court Judge Edward R. Korman to make EC available over-the-counter to all ages within 30 days of his decision. It comes from an administration which pledged to make science the cornerstone of public policy and instead has consistently flouted a wealth of accumulated evidence on emergency contraception. It also comes after several studies showing that current policy requiring prescriptions for some groups and not others has confused so many pharmacists that access to EC has been denied to many who were in fact legally eligible to obtain it quickly. In practice, the new policy will almost certainly perpetuate, not resolve, that confusion.
The battle to make EC available over-the-counter has gone on for over a decade and spanned both the Bush and Obama administrations. Judge Korman’s ruling was issued in response to the Center for Reproductive Rights’ (CRR) renewed lawsuit against the FDA seeking to expand over-the-counter access for all women to all brands of the morning-after pill, including Plan B One-Step and Next Choice. The most recent CRR lawsuit was filed after Kathleen Sebelius, secretary of the Department of Health and Human Services,overruled a 2011 FDA decision to make emergency contraception available over-the-counter to all ages, underscoring that the Obama administration, like its predecessor, has difficulties dealing with the realities of sex and pregnancy prevention.
The administration’s newest plan is to make EC available over-the-counter to individuals ages 15 and up, but still require prescriptions for those under age 15. While pharmacies can stock it in the family planning section of main store shelves, people seeking to buy EC will have to show identification with a birth date to a cashier. The newest plan comes after approval this week by the FDA of an amended application submitted by Teva, the manufacturer of Plan B One-Step, to allow OTC sale to those ages 15 and over, after an earlier request to do so had been denied by FDA in December 2011. The amended application was in any case superceded by the scientific evidence that led the FDA to rule in 2011 on making emergency contraception available OTC to all ages, the decision that was, as noted above, subsequently overturned by Sebelius. So in using the approved Teva application as the reason for this newest decision, the FDA is essentially reversing itself and ignoring the science on which its 2011 decision was based. Confused yet? Me too. It’s a complete circus, and I have no doubt that leadership at the FDA, which tried to make evidence-based policy in 2011, came under pressure from the White House to find the “fix” it announced today.
According to the FDA press release:
The product will now be labeled “not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified.” Plan B One-Step will be packaged with a product code prompting a cashier to request and verify the customer’s age. A customer who cannot provide age verification will not be able to purchase the product. In addition, Teva has arranged to have a security tag placed on all product cartons to prevent theft.
In addition, Teva will make the product available in retail outlets with an onsite pharmacy, where it generally, will be available in the family planning or female health aisles. The product will be available for sale during the retailer’s normal operating hours whether the pharmacy is open or not.
NPR reported that “the FDA said … Plan B One-Step will be packaged with a product code that prompts the cashier to verify a customer’s age. Anyone who can’t provide such proof as a driver’s license, birth certificate or passport wouldn’t be allowed to complete the purchase. In most states, driver’s licenses, the most common form of identification, are issued at age 16.”
There are several serious problems with this approach, apart from the fact that it ignores scientific and medical findings that call unequivocally for over-the-counter access for all.
First, the policy is not in compliance with the court ruling and therefore may in fact be thrown out. The Department of Justice will have to bring it before Judge Korman for approval and potentially seek a stay of his ruling altogether, throwing EC once again back to the courts.
Second, it still requires a prescription for a subset of the population potentially in need of EC, and therefore creates a significant barrier, especially for low-income teens under 15 years of age or those without ID who “look” younger and are denied access. Emergency contraception is for emergencies. It prevents unintended pregnancy by preventing ovulation, and is therefore most effective when taken within 72 hours of unprotected intercourse (including in cases when another contraceptive method may have failed). The need to see a physician to obtain a prescription that the public health and medical communities have deemed unnecessary is both time-consuming and expensive, and will entail additional indirect costs in terms of loss of time at school and work, likely on the part of both teens and their parents. This requirement serves the interests of no one except anti-choice opponents of birth control, and those in the Obama administration who still seem unable or unwilling to think beyond their own fears of teens and sex, or to go beyond personalizing policy to accommodate their own paternalistic fears of their daughters as sexual beings.
Third, language, lack of identification, and other potential barriers will remain an obstacle for many communities. Many 15- and 16-year-olds do not have IDs that display birth dates, and those who are well above the age limit but “look younger” to a clerk will be required to produce identification, documentation that many people in this country still do not have readily available or that, in a hurry, some might not remember to bring with them to the store.
Latinas, for example, face many of these barriers to access. In reaction to the decision, Jessica González-Rojas, executive director of the National Latina Institute for Reproductive Health, stated:
For too long, this important backup birth control method has been kept out of reach. Immigrant women and aspiring citizens of all ages have been hit particularly hard, since they are less likely to have government-issued identification. Putting emergency contraception on store shelves is a step in the right direction, but this decision still means another unneeded barrier for many Latinas who need contraception. Latinas already face far too many barriers, like poverty, discrimination and language, which prevent Latinas from accessing care.
For Latinas in particular, expanded access to emergency contraception is critical for making the best decisions for our families and ourselves. It’s disappointing that the FDA decided to undermine the recent court victory for immigrant women and young Latinas by introducing more unnecessary obstacles to emergency contraception, which is safe and necessary.
In a press release, Nancy Northup, president and CEO of the Center for Reproductive Rights, also pointed to the barriers to access left unaddressed by the policy:
The FDA is under a federal court order that makes it crystal clear that emergency contraception must be made available over the counter, without restriction to women of all ages by next Monday.
Lowering the age restriction to 15 for over-the-counter access to Plan B One-Step may reduce delays for some young women—but it does nothing to address the significant barriers that far too many women of all ages will still find if they arrive at the drugstore without identification or after the pharmacy gates have been closed for the night or weekend.
These are daunting and sometimes insurmountable hoops women are forced to jump through in time-sensitive circumstances, and we will continue our battle in court to remove these arbitrary restrictions on emergency contraception for all women.
It seems these days that no matter the administration in power, ensuring women have access to basic reproductive health care remains fraught with bias and mismanagement. On one hand, after going to ridiculous lengths to placate the United States Conference of Catholic Bishops (USCCB) on something as basic as including coverage for contraception under health insurance, the administration is fighting the USCCB and others in court over a policy to which the litigants are not even subject because these religious groups so hate the idea of women accessing contraception they are willing to empty collection plates to pay for court battles. On the other, advocates are now fighting the same administration in court on access to EC. And meanwhile, many pharmacies and pharmacists refuse to stock or dispense EC, no matter what, claiming personal religious objections.
The only thing that is clear is that the last chapter of this fight has yet to be written. Janet Crepps, a senior counsel for the Center for Reproductive Rights, told NPR Tuesday night that absent a stay, “we will want to go back to court as quickly as possible and ask the judge to hold them in contempt.”
So teens of any age can now buy prescription-strength drugs such as cough syrup and cold medicine over-the-counter without a prescription, but still cannot buy without hassles and barriers a drug that has been found to be safer than a wide array of other OTC drugs, and which has a small window of usefulness. I guess this administration would rather play Russian Roulette with teen pregnancy than make it easier to prevent.
January 31, 2013 — FDA regulators announced they will not take action regarding a vending machine that dispenses emergency contraception on Shippensburg University’s campus in Pennsylvania, MSN News reports.
The machine is located in the school’s health center, which can only be accessed by students and employees, and offers Plan B One-Step for $25. Under federal law, individuals ages 17 and older may purchase EC without a prescription.
The machine has been in place for about three years but it wasn’t widely known until it drew national media attention last year, prompting critics to claim it would encourage students to have sex. In response to the scrutiny, the Student Senate and the University Forum both passed resolutions in support of keeping the machine.
Erica Jefferson, an FDA spokesperson, in a statement said the agency “looked at publicly available information about Shippensburg’s vending program and spoke with university and campus health officials and decided not to take any regulatory actions.”
Peter Gigliotti, executive director for university communications and marketing, in a statement said an additional card reader has been installed on the machine, which students must use before accessing the drugs (Eng, MSN News, 1/29).
Dr. Susan Wood wrote about EC in The Washington Post.
In his May 25 Washington Forum column, Catholic Archbishop Donald W. Wuerl repeated the false claim that the requirement for insurance coverage of contraception under the Affordable Care Act mandates coverage of “abortion-inducing drugs.” Presumably, those who say this refer to emergency contraception (Plan B and Ella). It is time for the media and editors to stop treating this as a “he said-she said” situation.
Such a statement ignores the science of how emergency contraception works. This can be understandable since the label on emergency contraceptive pills is confusing to begin with and hasn’t changed since 1999. But recent, rigorous studies have found strong evidence that emergency contraception works by delaying ovulation. It may prevent fertilization, but it does not block implantation of a fertilized egg — and this is true for even the newest emergency contraceptive product, Ella.
Even if future studies show that some methods have a post-fertilization effect, so long as it works before pregnancy is established (implantation of a fertilized egg), it is a contraceptive. For a pregnant woman seeking an abortion, there is an FDA-approved option: the abortion pill, also called RU-486. But all of the contraceptive products covered under this health reform policy will not end a pregnancy. Accurate information is necessary if we must debate women’s access to contraception.
Susan F. Wood, Washington
The writer was assistant commissioner for women’s health at the Food and Drug Administration from 2000 to 2005.