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Administration Again Fails on Over-the-Counter Emergency Contraception

10:47 am in Uncategorized by RH Reality Check

Editor’s Note: The Justice Department filed suit to block Judge Korman’s ruling.

The Obama administration said Wednesday that girls under 15 should not have access to the most common morning-after contraceptive pill as the Justice Department filed a notice to appeal a judge’s order that would make the drug available without a prescription for girls and women of all ages.

Written by Editor-in-Chief Jodi Jacobson for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post.

This article was amended at 10:16 am, Wednesday, May 1, to correct the date of the amended application by TEVA to the FDA. It was resubmitted in 2012, not 2011.

See all our coverage of EC Over-the-Counter here.

Plan B contraceptive wrapper

New FDA emergency contraception regulations still do not go far enough.

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 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:

Read the rest of this entry →

Emergency Contraception and Moral Panic: Dissecting the Newest Misinformation Campaign

1:53 pm in Uncategorized by RH Reality Check

Written by Sidra Zaidi for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post.

Plan B contraceptive wrapper

Plan B emergency is under attack by religious conservatives again.

Reproductive rights advocates have something to cheer about: A federal judge ruled last week that the U.S. Food and Drug Administration (FDA) must allow universal access to Plan B over-the-counter for all ages. But anti-choice proponents want to have the last word on emergency contraception (EC), also known as the morning-after pill. Their strategy to limit access includes claiming that EC is unsafe for adolescents.

After Judge Edward Korman’s ruling, Charmaine Yoest of Americans United for Life said: “This decision allows the abortion industry to gamble with young girls’ health in distributing a life-ending drug, with no real understanding of the long-term implications on their bodies.”

A spokeswoman for the U.S. Conference of Catholic Bishops stated that the court’s action “undermines parents’ ability to protect their daughters … from the adverse effects of the drug itself.”

Once again, the anti-choice community is using inaccurate information to limit women’s and girl’s reproductive rights. There is no evidence that Plan B is a “life-ending drug:” EC is not the abortion pill. It works by preventing or delaying ovulation and does not interfere with implantation of a fertilized egg or with an existing pregnancy.

Nor do any studies demonstrate that EC has “adverse effects” let alone “long-term implications” for girls’ bodies. Plan B is safer than aspirin: It has few or no immediate side effects and no long-term side effects. In fact, the drug meets all of the FDA’s objective criteria for switching a drug from prescription to non-prescription status: It is non-toxic, it is impossible to overdose on it, it has no harmful effects on a woman or teen or a possible pregnancy, and it is not addictive. Girls and women are able to self-diagnose their risk and understand how to use EC from simply reading the label. Finally, Plan B does not require any medical screening or intervention from a health care worker to use it safely.

FDA Commissioner Margaret Hamburg recognized EC’s safety in December 2011 when she confirmed evidence of Plan B’s suitability for all ages without requiring a prescription. What’s more is that her approval for universal over-the-counter EC access has been endorsed by the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the Society of Adolescent Health and Medicine.

Judge Korman also took compelling scientific evidence for Plan B’s safety into account. He wrote in his opinion that Secretary of Health and Human Services Kathleen Sebelius’ countermand of FDA decision-making was “politically motivated, scientifically unjustified, and contrary to agency precedent.”

In 2011, Secretary Sebelius claimed her actions were based on lack of evidence that the drug was safe for girls as young as eleven. Judge Korman was right to counter that “the number of 11-year-olds using these drugs is likely to be miniscule.” A study published last week in Pediatrics bolsters his assertion: According to author Lawrence Finer, only 0.6 percent of 10-year-olds, 1.1 percent of 11-year-olds and 2.4 percent of 12-year-olds have ever had sex.

In the words of the federal judge, claiming that Plan B is unsafe for 11-year-olds is an “excuse to deprive the overwhelming majority of women of their right to obtain contraceptives without unjustified and burdensome restrictions.”

Curiously enough, Secretary Sebelius has made no move to impose an age limit on purchasing aspirin, an over-the-counter drug that is linked to Reye’s syndrome in children under age 16. Nor has the FDA restricted children’s access to energy drinks, despite the fact that over a dozen deaths have been linked to highly-caffeinated beverages that are marketed to youth.

There is no doubt, then, that Secretary Sebelius’ actions to limit EC, one of the safest drugs on the market, were political. The timeline of events indicates as much: The secretary’s FDA override took place in December 2011 immediately before she announced President Obama’s controversial contraceptive mandate one month later

When responding to Judge Korman’s decision, anti-choicers perhaps sensed that evidence-based arguments are effective in the courts. As a result, their offensive tactics have slightly shifted gears from making claims about EC’s safety to arguing that universal EC access potentially coerces girls and increases the risk of untreated STDs.

For example, Anna Higgins, director of the Center for Human Dignity at the Family Research Council, said, “There is a real danger that Plan B may be given to young girls, under coercion or without their consent.”

Donna Harrison of the American Association of Pro-Life Obstetricians and Gynecologists said in a statement, “You’re taking girls at highest risk of STD and isolating them from medical care.”

Harrison’s statement, however, misses the crux of why emergency contraception is important: It is to be used in an emergency. STD education, screening, and treatment are obviously vital components of sexual and reproductive health. Girls who have been sexually violated and potentially exposed to HIV are especially in dire need of HIV prophylaxis. But there is no conclusive evidence that providing EC to adolescents increases their risk of STDs or contributes to a rise in risk-taking behavior. Moreover, if a girl fears that she may become pregnant, she must be able to access EC as soon as possible — Plan B is most effective within 72 hours, and only up to five days, after unprotected sex.

Read the rest of this entry →

Court Orders FDA to Make Emergency Contraception Available Over-the-Counter for All Ages

11:42 am in Uncategorized by RH Reality Check

Written by Jodi Jacobson for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post.

In a long-awaited decision released early this morning, U.S. District Court Judge Edward Korman ordered the U.S. Food and Drug Administration (FDA) to make emergency contraception available over-the-counter to women of all ages, marking a major win for public health and women’s rights in a year that has seen science otherwise buried under an avalanche of anti-choice politics. In his decision, Judge Korman orders the FDA to make levonorgestrel-based emergency contraception available over-the-counter without an age or point-of-sale restriction.

Today’s order was issued in response to the Center for Reproductive Rights’ (CRR) renewed lawsuit against the agency seeking to expand over-the-counter access to all brands of the morning-after pill, including Plan B One-Step and Next Choice, to women of all ages.

The court has ordered the FDA to make emergency contraception available without a prescription and without point-of-sale or age restrictions within 30 days, with the option to limit the change to only Plan B One-Step if the agency “actually believes there is any significant difference between the one- and two-pill products” and to require new labeling if necessary.

Women’s rights groups are celebrating the decision.

“Today science has finally prevailed over politics,” said Nancy Northup, president and CEO of CRR, which brought this and other lawsuits. “This landmark court decision has struck a huge blow to the deep-seated discrimination that has for too long denied women access to a full range of safe and effective birth control methods. “Women all over the country will no longer face arbitrary delays and barriers just to get emergency contraception. It’s a true victory for all women, especially young women, women without government-issued identification, and those who live in areas with limited pharmacy hours,” she added.

Susannah Baruch, interim president and CEO of the Reproductive Health Technologies Project, which has been a leading advocate for emergency contraception, concurred: “Today we celebrate a long overdue victory for all women. Our decade long struggle is finally over. Emergency contraception will now sit on store shelves allowing timely access to this important product used to prevent unintended pregnancy. We urge Secretary Sebelius and the FDA to move swiftly to put emergency contraception on store shelves and into the hands of women and couples who need it.”

In a statement, the National Latina Institute for Reproductive Health applauded the ruling:

For Latinas in particular, expanded access to emergency contraception is critical for making the best decisions for our families and ourselves. For too long, this important backup birth control method has been kept behind the counter and out of reach. Immigrant women and new Americans of all ages have been hit particularly hard, since they are less likely to have government identification. This decision removes one barrier for Latinas who need contraception — though others, like poverty, discrimination, language and immigration status, remain.

This victory came after a long and unnecessarily difficult battle that was marred by politics, irrespective of the political party in charge. (See timeline following article.)

The FDA first approved emergency contraception (EC) for prescription use in 1999. Subsequently, study after study showed the safety of EC for women of all ages seeking to prevent an unplanned pregnancy after unprotected sex or contraceptive failure. In 2003, the first application was made to the FDA to approve EC for over-the-counter (OTC) sales. And thus began a long game of politics that has spanned both the Bush and Obama administrations. First, the Bush administration refused to act to make EC available OTC, resulting in the first successful lawsuit by advocates to ensure that science, rather than politics, governed women’s access to this method of basic preventive reproductive health care. EC was first made available OTC for women ages 18 and older, though the science clearly affirmed its safety for younger women.

After years of advocacy and further scientific proof of efficacy and safety, it seemed that finally EC would be made available over the counter for all women. However, in a deeply controversial move in December 2011, Kathleen Sebelius, secretary of the Department of Health and Human Services (HHS), overruled the decision by FDA Commissioner Margaret Hamburg to approve over-the-counter sales of Plan B One-Step. President Obama publicly supported Sebelius’ decision, in what was widely seen as a political move. Public health, medical, and legal groups went into overdrive, conducting a wide-ranging public education campaign, launching a citizen’s petition, releasing statements in support of EC OTC, and filing the lawsuit that led to today’s decision, in which Judge Korman called Sebelius’s actions “politically motivated, scientifically unjustified, and contrary to agency precedent.” Said Judge Korman, “The decisions of the Secretary with respect to Plan B One-Step and that of the FDA with respect to the Citizen Petition, which it had no choice but to deny, were arbitrary, capricious, and unreasonable.”

“It’s shameful it has taken over a decade and a federal court order for the U.S. government to implement in policy what studies and experience have proven time and time again — emergency contraception is safe and effective and should be available for women of all ages,” said Janet Crepps, senior counsel for CRR.

Currently, EC is available to women ages 17 and older without a prescription; young women under 17 are required to obtain a prescription from a physician. Even for women 17 and older, however, the medication is available only at health clinics or pharmacies, upon request and with adequate identification.

This unique and unnecessary dual scheme, notes CRR, has impeded access even for women who are allowed to obtain the drug without a prescription, as evidenced by several studies, including one published in the journal Pediatrics earlier this year. A total of 943 pharmacies in five major cities were contacted twice by researchers at Boston University — once the researchers posed as a 17-year-olds and another time as physicians. The study found that there misinformation was common regarding who can take EC and at what age it is available without a prescription, creating barriers to timely access. According to the research, nearly 20 percent of the drugstores contacted denied the “17-year-olds” access to the pill.

With the court’s ruling today, drug companies can now apply to make EC available to women of all ages and at stores other than just pharmacies — eliminating human error in determining who can and cannot purchase the medication.

#####

CRR Emergency Contraception Case Timeline

July 28, 1999: The U.S. Food and Drug Administration (FDA) approves Plan B, an emergency contraceptive medication, for prescription use.

February 14, 2001: The Center for Reproductive Rights files a Citizen Petition with the FDA on behalf of over 70 medical and public health organizations to make Plan B available without a prescription or over-the-counter (OTC).

April 21, 2003: Women’s Capital Corporation, the manufacturer of Plan B, files an application with the FDA to make Plan B available OTC.

Late December 2003/January 2004: After a panel of FDA experts recommends approval of the Plan B application, Dr. Steven Galson, the head of the office responsible for making the final decision, informs his staff that the regular procedures won’t be followed this time, and that that office won’t make the final decision. (Jenkins deposition)

December 2003 to Jan 17, 2004: Galson confesses to a co-worker that he has to reject the Plan B application because he’s afraid he’ll lose his job. (Jenkins deposition) Dr. Janet Woodcock, the second in command at the FDA, tells a colleague that the agency first has to reject the application, then approve the drug later with an age restriction in order to “appease the administration’s constituents.” (Houn deposition)

May 6, 2004: The FDA denies the manufacturer application and suggests Barr, the drug’s new manufacturer, amend the application to request an OTC switch only for women 16 and older. (Barr revises the application; the FDA schedules a decision for January.)

January 21, 2005: After the FDA fails to meet its deadline, the Center files a lawsuit against the agency for ignoring science and holding Plan B to a different standard than other drugs.

August 26, 2005: The FDA misses its second deadline to rule on Barr’s application. In a peculiar move, the agency requests the public provide input over an indefinite period of time on how to dispense the drug.

February 24, 2006: The Center is cleared to depose high-level FDA officials. The New York magistrate judge cites strong showing of “bad faith and improper behavior” by the FDA.

June 9, 2006: FDA denies Citizen Petition for the first time.

August 24, 2006: The FDA agrees to make Plan B available without a prescription, but only to women 18 and older who can provide government issued identification. The FDA also requires that Plan B be sold behind pharmacy counters.

March 30, 2007: Center files for summary judgment in the case, arguing that the undisputed facts found in evidence gathered through discovery make it unnecessary for the court to hold a trial, and that the court should order the FDA to make Plan B available without a prescription to women of all ages.

March 23, 2009: Court orders the FDA to approve Plan B for those 17 and older without a prescription and to reconsider the Citizen Petition and all age and other restrictions on OTC access.

July 10, 2009: The FDA approves Plan B OTC for those 17 and older. The FDA also approves Plan B One-Step, which is a product that consists of the same drug as Plan B but in one pill rather than two. Both Plan B and Plan B One Step are OTC for those 17 and older and prescription-only for those 16 and younger.

August 28, 2009: The FDA approves Next Choice, a generic version of Plan B, under the same regime: OTC for those 17 and older and prescription-only for those 16 and younger.

November 16, 2010: The Center files a motion for contempt of court against the FDA for failing to reconsider the Citizen Petition and the current restrictions on OTC access to Plan B.

December 1, 2010: After receiving FDA approval for prescription-only use, Watson Pharmaceuticals launches ella, another form of emergency contraception (ulipristal acetate).

February 7, 2011: Teva Pharmaceuticals, the manufacturer of Plan B One-Step, files a supplemental new drug application (sNDA) with the FDA so that the drug will be available OTC for women of all ages.

Dec. 7, 2011: HHS Secretary Sebelius takes an unprecedented step to block FDA Commissioner Hamburg’s approval of Plan B One-Step manufacturer’s application for OTC status, which included additional data that confirmed its safety for all-ages use. The next day, President Obama publicly supports Sebelius’s decision, “as a father of two daughters.”

Dec. 12, 2011: On the eve of a court hearing on the Center’s motion for contempt, the FDA denies the Citizen Petition for a second time based on a lack of teen-specific data for the two-dose medication, despite the volume of data before the FDA on two-pill emergency contraception products, which data for one pill products of emergency contraception confirmed.

Dec. 13, 2011: Judge denies contempt motion because FDA had ruled on the Citizen Petition the night before, but invites CRR to reopen the case. Judge notes striking similarities between recent actions and 2005-2009.

Feb. 8, 2012: CRR reopens its case, filing a motion for preliminary injunction and summary judgment for immediate relief that would allow OTC access for all levonorgestrel-based emergency contraceptives (both one and two pill versions) without any age or point of sale restrictions. CRR also adds Sebelius as a defendant and supplements the complaint.

February 16, 2012: Judge Korman issues Order to Show Cause to Defendants “why the FDA should not be directed to make Plan B available to those persons whom the studies submitted to the FDA demonstrate are capable of understanding when the use of Plan B is appropriate and the instructions for its due.”

March 9, 2012: Teva Women’s Health, Inc., the manufacturer of Plan B One-Step, files a motion to intervene in the case.

April 27, 2012: Hearing held on Court Order to Show Cause and Motion of Teva Women’s Health to Intervene.

April 5, 2013: Judge Korman orders FDA to make levonorgestrel-based emergency contraception available over the counter without age or point of sale restriction.

Emergency Contraception Should Be Available Over The Counter. And You Can Make That Happen

11:56 am in Uncategorized by RH Reality Check

Written by Kirsten Moore for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post.

Plan B on the shelf - in Canada.

Last week’s announcement from the esteemed American College of Obstetricians and Gynecologists (ACOG), suggesting it’s time to make oral contraceptives accessible without a prescription, is the perfect way to re-ignite and re-engage public conversation about making emergency contraception (EC) available without restriction. We cannot afford another decade of political delays when it comes to common sense measures to improve women’s health.

Doctors are taking the lead by acknowledging they’ve become unnecessary obstacles between women and their birth control. That is an example politicians need to follow. Medical science, not political ideology, should govern which products are safe and effective. It is clear women of all reproductive ages will be better off when emergency contraception is easily accessible and in their hands.

One year ago next week the Food and Drug Administration was poised to announce that EC had been approved for on-the-shelf access, such that it could appear at your local pharmacy between condoms and pregnancy test kits. But Health and Human Services (HHS) Secretary Kathleen Sebelius stepped in at the last minute and ruled that Plan B One-Step and its generic equivalent must remain behind-the-counter. That decision led to confusion and unnecessary obstacles for women, teens, and couples at the very moment clarity was needed most. For example, we know that:

  • Doctors and teens have been given misinformation about the age restrictions applied to emergency contraception over the counter (currently 17) or told that teens could not get the product at all (not true). This confusion helps no one.
  • Men have been told by pharmacists in several states around the country that they could not buy EC (not true), presenting obstacles and delays when timing matters.
  • Rape survivors have been denied access to EC by doctors and prison staff.
  • Individuals without government issued identification may have difficulty accessing EC because of the restrictions.

In addition to the practical confusion the Sebelius ruling created, it also set a dangerous policy precedent. Never before has HHS overruled the FDA on a product that had been as thoroughly vetted and researched as EC. To the extent the concern about teens accessing EC was something the Obama Administration didn’t want to have to deal with during the election, they should clearly understand now that the women, young voters, and communities of color who stood in line at the polls did so in part because access to contraception, and the choice it represents in all our lives, is important.

For example, today 82 percent of teen pregnancies are unintended. Seventy percent of  teens in New York City who became pregnant between 2011-2012, dropped out of school Increased, evidence-based access to EC  could give these teens a second chance to prevent pregnancy and stay in school. But research reveals that because of widespread confusion, 50 percent of teens seeking EC were told the wrong age requirements for buying it. 

The science supporting EC hasn’t changed, but the politics sure have. We need to send a clear signal to Secretary Sebelius that women’s reproductive health and medical science should be the driving force behind public policy. A broad coalition of medical professionals and advocates is launching a petition today to urge Secretary Sebelius to revisit the evidence and remove the restrictions.

Please sign it and share it with your friends. Engage people in conversation about the important issues on social media and help demonstrate the strong consensus for common sense public policy that puts health and science over political ideology. We want to get as many signatures as possible before the one-year anniversary of the Sebelius decision on December 7th, please sign, share, and continue to make your voice heard.

Read the rest of this entry →

He-Men, Virginity Pledges and Bridal Dreams: Obama Administration Quietly Endorses Dangerous Ab-Only Curriculum

10:28 am in Uncategorized by RH Reality Check

Photobucket

Written by Debra Hauser, Monica Rodriguez, Elizabeth Schroeder and Danene Sorace for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post.

Sometime this month, an updated list of “evidence-based” teen pregnancy prevention programs was endorsed by the Department of Health and Human Services (HHS) and posted to the website of the Office of Adolescent Health (OAH).

No notice, not even a press release to announce the addition of three programs to the coveted list of 28 deemed effective and carrying the HHS seal of approval. Until now, this list was the holy grail of the Administration’s commitment to a science-based approach to teen pregnancy prevention and a directive for grantees of the President’s Teen Pregnancy Prevention Initiative (TPPI).

So why the secrecy about the new additions? What does the Administration have to hide?

Because one of the “new” programs is actually an old, dis-proven and dangerous abstinence-only-until-marriage program.

We have been around long enough to expect politics as usual in Washington, D.C. The backroom deals and secrecy should not surprise us. The jettisoning of young people and their sexual health for political expediency is not new. But, this blatant hypocrisy needs to stop. This latest example is just too much.

Perhaps the Administration realized that the inclusion of Heritage Keepers Abstinence Education on this select list would call into question its commitment to young people and their sexual health. Once again, they have succumbed to the political pressure of social conservatives and allowed the ideology of the right to prevail over the health and well-being of the nation’s youth. The Obama Administration’s endorsement of this abstinence-only-until marriage program runs in direct contradiction to its stated commitment to the health and well-being of young people and, quite possibly, its promise to uphold science and evidence.

The Trampling of Young People’s Sexual Health

The President has talked about his administration’s commitment to LGBT health and rights by recording his own “It Gets Better Video” and announcing support for both the Safe Schools Improvement Act and Student Non-Discrimination Act. And, the CDC has recognized the disproportionate impact of the HIV epidemic on young men who have sex with men and has committed millions of federal dollars to reducing the burden of disease on this population.

Yet, at best Heritage Keepers Abstinence Education ignores LGBT youth – and at worst it promotes homophobia. The stigmatization of LGBT youth throughout the program reinforces the cultural invisibility and bias these students already face in many schools and communities. The curriculum’s focus on marriage as the only appropriate context for sexual behavior further ostracizes LGBT youth and the children of LGBT parents who still cannot legally marry in most states.

The Director of the CDC has called teen pregnancy prevention and HIV prevention two of the country’s six “winnable battles,” and recent analysis of National Survey of Family Growth data trends indicates that significant reductions in teen births have been primarily fueled by increased contraceptive use.

Today roughly 40 percent of high school students have had sex and young people under age 29 continue to account for approximately 30 percent of all new cases of HIV infection.

Yet, Heritage Keepers Abstinence Education does not include information about the health benefits of contraception or condoms. Read the rest of this entry →

The Cost of Contraception in Insurance Plans: What the Data Say

11:08 am in Uncategorized by RH Reality Check

Written by Editor-in-Chief Jodi Jacobson for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post.

In 2011, the Department of Health and Human Services examined the issue of just how much it costs insurance companies to cover contraception. Based on data from a wide range of peer-reviewed medical and public health data, evidence-based research and actuarial studies as well as prior experience with insurance policies in which contraception is covered without a co-pay, the HHS analysis found that it costs more not to provide contraception than it does to provide it.  HHS concluded:

While the costs of contraceptives for individual women can be substantial and can influence choice of contraceptive methods, available data indicate that providing contraceptive coverage as part of a health insurance benefit does not add to the cost of providing insurance coverage.

HHS guidelines for including contraceptive care and supplies as part of the essential package of primary health care for women were based on this analysis as well as on recommendations to HHS from the Institute of Medicine, which conducted an extensive study, relying on independent physicians, nurses, scientists, and other experts as well as evidence-based research to draw conclusions and formulate its recommendations.

Here, in brief, is what the cost analysis said.

The Evidence

“Evidence from well-documented prior expansions of contraceptive coverage,” states the HHS issue brief, “indicates that the cost to issuers of including coverage for all FDA-approved contraceptive methods in insurance offered to an employed population is zero.”

In 1999, when Congress required the health plans in the Federal Employees Health Benefits (FEHB) program to cover the full range of FDA-approved contraceptive methods, premiums for 1999 had already been set when the legislation passed. The Office of Personnel Management (OPM), which administers the FEHB program, provided for a reconciliation process for insurers who found this requirement burdensome. But, HHS notes:

[T]here was no need to adjust premium levels because there was no cost increase as a result of providing coverage of contraceptive services.

In other words, no insurance company complained because they found it was to their advantage to provide the service.

This is critical because it is perhaps the best model for the nation in terms of what to expect. The FEHB program is the largest employer-sponsored health benefits program in the United States, and at the time, notes HHS, “it covered approximately 9 million Federal Employees, retirees and their family members and included approximately 300 health plans.”

Likewise a review of a similar mandate in Hawaii found no increase in insurance costs.  In 1999, Hawaii prohibited employer group health plans from excluding contraceptive services or supplies from coverage, requiring them to include FDA-approved contraceptive drugs or devices to prevent unintended pregnancy.

A report on this experience by the Insurance Commissioner of Hawaii concludes that the mandate did not appear to increase insurance costs in any of the four surveyed health plans in Hawaii servicing employer groups.

What do reviews of actuarial data show?

The direct costs of providing contraception as part of a health insurance plan are very low and do not add more than approximately 0.5 percent to the premium costs per adult enrollee, as per studies from three actuarial firms–Buck Consultants, PriceWaterhouseCoopers (PwC), and the Actuarial Research Corporation (ARC)–which estimated the direct costs of providing contraception coverage. 

More recent analysis of actuarial data conducted in July 2011 by the Actuarial Research Corporation and using data from 2010 estimated that contraceptive coverage without a co-pay costs roughly $26 per year per enrolled female.

However, notes HHS, “as indicated by the empirical evidence described above, these direct estimated costs overstate the total premium cost of providing contraceptive coverage.”

When medical costs associated with unintended pregnancies are taken into account, including costs of prenatal care, pregnancy complications, and deliveries, the net effect on premiums is close to zero. One study author concluded, “The message is simple: regardless of payment mechanism or contraceptive method, contraception saves money.

Counting indirect costs–such as time away from work and productivity losses–further reduces the total cost to an employer. 

A model developed by Global Health Outcomes that incorporates costs of contraception, costs of unintended pregnancy, and indirect costs found that covering contraception saves employers $97 per year per employee. Similarly, the PwC actuaries state that after all effects are taken into account, providing contraceptive services is “cost-saving.”

Does providing contraception through public programs also save costs?

Yes.

As HHS notes:

Each year, public funding for family planning prevents about 1.94 million unintended pregnancies, including almost 400,000 teen pregnancies.  Preventing these pregnancies results in 860,000 fewer unintended births, 810,000 fewer abortions and 270,000 fewer miscarriages.  More than nine in 10 women receiving publicly-funded family planning services would be eligible for Medicaid-funded prenatal, delivery, and postpartum care services upon pregnancy.  Avoiding the significant costs associated with these unintended births saves taxpayers $4 for every $1 spent on family planning.

Evidence that expanding access to contraception through Medicaid is unequivocal: Increased access saves taxpayer money.

During the 1990s, HHS states:

…many states implemented Medicaid Section 1115 Family Planning Demonstrations.  An independent evaluation of the experience of six of these states found that all six Demonstrations yielded savings, with annual state savings ranging between $1.3 million in New Mexico and nearly $30 million in Arkansas.

As of August 1, 2010, 27 states, including States like Pennsylvania, Texas, Florida, and Virginia had expanded Medicaid eligibility for family planning services under waivers that stipulated that these expansions be budget neutral.  Based on this experience, the Congressional Budget Office has estimated that expanding family planning to all States would save $400 million over 10 years.

Why would insurance companies provide contraception without a co-pay to their female employees?  The answers are clear.

 

Teen Immaturity Is Not the Problem with Plan B. The Immaturity of Politicians Is.

11:56 am in Uncategorized by RH Reality Check

Plan B (photo: vixyview/flickr)

Plan B (photo: vixyview/flickr)

Written by Catherine Rivera for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post.

Teenagers get a lot of crap for going above, under, and around the laws that are established to keep them “safe.” Some of these laws are completely well-founded. Others are not.  President Obama and Kathleen Sebelius, betrayed millions of teens and young people (along with their doctors, parents, and supportive adults) by telling them that they were not mature enough to decide to prevent a pregnancy.

As a recent teenager, I want to set the record straight on some things that our politicians may not have realized. Teenagers do have the maturity to know how and when to take Plan B. Teenagers know that emergency contraception is what you use when the condom breaks, when pulling out doesn’t go as planned, when contraception wasn’t available. They know it can stop pregnancy from occurring and that they shouldn’t wait until Monday when they MAY be able to go to the doctor to get a prescription.

Because let’s face it, sex for teenagers happens more often when their parents are out for the night, when they don’t have school the next morning, and when they have the most free time. Monday isn’t going to cut it and while teenagers may want to go to the pharmacy and pick up Plan B because they want to protect themselves or their partners from becoming pregnant, they can’t. Not because they are going to abuse it, not because they don’t know how to use it, not because they lack the maturity to know what consequence the lack of action could have, but because politicians have deemed that it’s immoral to let teenagers to access Plan B. They are denying teenagers access to something that could help them continue being teenagers, because isn’t that what every parent, neighbor, and president wants?

Teenagers under 17, who can’t legally access Plan B, do sometimes have access to it. The majority of people that I know who have used Plan B were not 17 and they didn’t go to a doctor to get a prescription to get emergency contraception. Teenagers know that there are faster ways to get Plan B and so, while millions of adults don’t have the maturity to admit simple (or big) mistakes, teenagers admit to their friend, their sibling, their cousin that they messed up and they need that person to buy them or their partner emergency contraception. These teenagers use their birthday, babysitting, or lawn- mowing money to buy a $50 pill that will prevent a pregnancy and enable them to continue being teens. Read the rest of this entry →

Disappointed Doesn’t Cut It Anymore: A Mother’s Rebuttal of President Obama’s Plan B Politics

1:38 pm in Uncategorized by RH Reality Check

Written by Kate Stewart for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post.

See all our coverage of Kathleen Sebelius’ 2011 Emergency Contraception Reversal here.

Disappointed doesn’t cut it anymore.

Disappointed, angry, dismayed — these are only some of the emotions I am feeling this afternoon after hearing President Obama’s poor excuse for restricting access to Plan B One Step.

I am also scared.

Scared about the health of my daughters.  As the mother of two daughters, just like President Obama, I try to use “common sense” as much as possible. But, also like President Obama, I am not a doctor; I am not a scientist. I use my own judgment when it comes to things I am confident I can handle — a case of the sniffles, a little cold.

But, I also understand that it is my responsibility as a parent to know when I don’t know all the answers and it’s time to turn to experts. And that, apparently, is where the President and I disagree.

When my daughter’s pediatrician gives me medical advice, I listen. Carefully. American Academy of Pediatrics and the Society of Adolescent Health and Medicine make recommendations about my daughters’ health, that matters to me. A lot. And I believe it should.

Today, President Obama has made the irresponsible – and nearly incomprehensible — decision to support HHS Secretary Kathleen Sebelius’ move to block the FDA from expanding access to Plan B One-Step emergency contraception. Whether the President’s decision was motivated by well-intentioned ignorance or political cowardice is beside the point. Either way, this move will adversely impact millions of women, particularly young women, across the country.

President Obama has decided to ignore scientific research and medical advice and has sacrificed the health of young women. And I want to know why. Why, Mr. President? Why would you reject years of research and the best scientific thinking the medical community has to offer? Why, for the first time in U.S. history, did your administration intervene to overrule the FDA’s ability to make decision about medical science? Read the rest of this entry →

After the EC Decision, A Lifelong, Third Generation Democrat Wonders Where She Belongs

11:50 am in Uncategorized by RH Reality Check

Kathleen Sebelius (Photo: americanprogress, flickr)

Kathleen Sebelius (Photo: americanprogress, flickr)

Written by Kari Ann Rinker for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post.

See all our coverage of Kathleen Sebelius’ 2011 Emergency Contraception Reversal here.

President Obama visited Osawotamie, KS on Tuesday and gave a speech about the economy.  His speech focused on fair play, fair shares and fair shots for all citizens.  I went to Osawotamie to ask the President to extend that message of fairness to the women of the nation, regardless of the religious affiliation of their employer.  I went to the speech to represent the interests of a coalition consisting of Planned Parenthood of Kansas and Mid-Missouri, MoveOn.org and Kansas NOW.  The following is from our press release…

President Obama has continually spoken out about his administration’s commitment to women and women have supported the President in many of his initiatives, including the passage of the Affordable Care Act.

We stand united in Kansas, encouraging the President to honor his commitment to all women by standing in firm opposition to the expansion of the conscience clause of the birth control mandate within the Affordable Care Act.

Peter Brownlie, President and CEO of Planned Parenthood of Kansas and Mid-Missouri said, “President Obama should reject efforts to take away the birth control coverage benefit from millions of Americans who work at religiously-affiliated hospitals, universities, schools, or organizations.  These are nurses, teachers, janitors, and other workers who should not be discriminated against and denied a benefit that the vast majority of Americans will receive.”

Kari Ann Rinker, State Coordinator of Kansas NOW stated, “We ask the President to stand up to the U.S. Conference of Catholic Bishops and other opponents of contraception and just say no to the continued bullying of corporate religious interests, whose demands run counter to the individual conscience of the millions of women who could potentially be effected by this expansion. The President’s vague answers and lack of official statement on this subject is disconcerting.” Read the rest of this entry →

Denying Access to Plan B: An Act of Political Cowardice

11:43 am in Uncategorized by RH Reality Check

Written by Lorraine Berry for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post.

Fool me twice. I’m an idiot.

I keep thinking someone in this administration is going to take a stand that will mean something.

It’s a small thing, really, but a huge thing when you’re a teenager. You need access to emergency contraception and you can’t get it because your government is controlled by fundamentalist body haters who think that sex is for procreation only.

*****

I’m still hunting for the right words to say. Nearly 40 years after abortion was made legal in this country, 50 years since we’ve had the Pill, and women are still told, day-after-day, that the only thing that matters about them is their ability to bear children. And if bearing a child costs you your life, well, what greater sacrifice can you make? (And besides, there are plenty of women to replace you.)

*****

To visit the local cemeteries is to see this philosophy carved in stone–acres of stones that tell the same story. One man will be buried with two, often three, wives. He died in his 80s. The first two wives died in their 20s or early 30s, but the third wife grew old with him. Frequently, there are newborns whose death dates approximate the death dates of their mothers.

We tell ourselves that this was before modern medicine. That puerperal fever, or ruptured uteri, or hearts weakened by childhood diseases and then too weak to bear the strains of pregnancy, that these things are all things of the past.

But, we maintain maternal mortality statistics because pregnancy is still potentially deadly. And lest any American think that we have the best health care system in the world, ask yourself why our rates of maternal death are among the highest in the industrialized world?

****

The FDA cannot find a single reason why Plan B contraception can’t be on a shelf where anyone can buy it. Katherine Sebelius, and her boss, Barack Obama, they moved the football again.

We were all so happy when Obama chose a pro-choice champion to head HHS. But, it turns out, just like her boss, she’s a political coward.

So what, the right wing thinks teenagers shouldn’t be having sex? How has that changed in all the years that we’ve been talking about it?

Sebelius, no doubt ordered to by her boss, overruled the FDA, denied scientific evidence, to make moralistic assholes happy.

I really thought you were going to hold the football steady this time, Obama. I really did.

I’m an idiot. I keep hoping against hope that you’re not going to throw women under the bus. That you can stand up to the ladies who swoon at the Concerned Women for America. You think they’re going to vote for you because you said no to Plan B?

I know you’re not stupid.

You’re a coward.