Justice Department Agreed To Stop Blocking Expanded Access To Contraceptives

NY Times: “U.S. Drops Bid to Limit Sales of Morning-After Pill.” A June 10 New York Times article titled “U.S. Drops Bid To Limit Sales of Morning-After Pill” reported that the Department of Justice (DOJ) decided to drop its effort to block a U.S. District Court ruling that ordered the Food and Drug Administration (FDA) to approve the emergency contraceptive pill Plan B One-Step for over-the-counter distribution without age restrictions. According to The New York Times [emphasis added]:

The Obama administration has decided to stop trying to block over-the-counter availability of the best-known morning-after contraceptive pill for all women and girls, a move fraught with political repercussions for President Obama.

[...]

In its letter to the court, the Justice Department outlined the procedural steps that the F.D.A. plans to take. It said the maker of Plan B One-Step, Teva Pharmaceuticals, has been asked to “promptly” file an application asking for no age or sales restrictions, and that the “F.D.A. will approve it without delay.”

Once that is done, the F.D.A. expects makers of generic versions of Plan B One-Step -- the most popular of those is Next Choice One Dose -- to ask for a similar arrangement. The F.D.A. will evaluate those requests, based on whether it decides to give Plan B One-Step any type of market exclusivity, but most likely generic pills will also eventually be available without restrictions.

The Justice Department said it would not remove restrictions from two-pill emergency contraceptives because it is concerned that young girls might not be able to adequately understand how to take two separate doses. But two-pill versions are a diminishing fraction of the market. [The New York Times, 6/10/13]

NY Times: Fight For Unrestricted Access To Plan B “Is More Than A Decade Old.” The Times also outlined the decades-long legal battle that led to the Justice Department's decision:

The fight to make emergency contraceptives universally available without a prescription is more than a decade old. Plan B, the trade name for the morning-after pill, was approved in 1999 as a prescription-only product. In 2001 the Center for Reproductive Rights filed a citizens petition for it to be made available over the counter or without a prescription.

By December 2011, after years of pressure from women's reproductive rights groups and the companies selling the drug, the F.D.A. was poised to lift all age restrictions. By then the F.D.A. also said it had determined that the drug was safe. But in an unprecedented move Ms. Sebelius overruled the agency. She said at the time that she had based her decision on science because she said the manufacturer had failed to study whether the drug was safe for girls as young as 11, about 10 percent of whom are physically able to bear children.

In April, Judge Korman once again ordered the government to make all morning-after pills available without a prescription and without any sales restrictions. In a stridently worded ruling, Judge Korman wrote that Ms. Sebelius's decision to overrule the F.D.A. “was politically motivated, scientifically unjustified, and contrary to agency precedent.” [The New York Times, 6/10/13]

Right-Wing Media Reacted By Stoking Fears About Widespread Plan B Access

Rush Limbaugh: Obama Administration Approved “The Abortion Pill, The Morning-After Pill.” On the June 11 edition of his radio show, Rush Limbaugh reacted to news of the DOJ decision by falsely labeling Plan B “the abortion pill”:

You can walk into any pharmacy, any drug store, and get the abortion pill, the morning-after pill." [Premiere Radio Networks, The Rush Limbaugh Show, 6/11/13]

Fox Contributor Laura Ingraham: Increased Access To Plan B Is “A Good Deal For Pedophiles” And Statutory Rapists. On the the June 11 edition of Fox News' Fox & Friends, Fox contributor Laura Ingraham stoked fears that expanded access to Plan B could subject young women to abuse:

INGRAHAM: Yeah, well, I mean it's a good deal for pedophiles, a good deal for people who commit statutory rape against young girls. And if mothers and fathers across this country hear this and they think, well, guess my daughter or her boyfriend or her rapist can go out to a pharmacy and get a bunch of, you know, hormone pills to give a little girl, we don't really know the long-term effect of --

STEVE DOOCY (co-host): No--

INGRAHAM: Spiking or dropping a little girl's, you know, in many cases, a young woman's, or little girl's, hormonal levels. It's outrageous. These girls can't, you know, we say it all the time, they can't get their ears pierced, they can't take a Advil at school without parental permission, yet they can go into a pharmacy in this brave new world of women's equality and, quote, “reproductive health,” and get, and get a morning-after pill. I mean, I think it empowers men who want to abuse women. [Fox News, Fox & Friends, 6/11/13, via Media Matters]

Gateway Pundit's Jim Hoft: “Obama Now Offers Morning After Pills To Little 5 Year-Old Girls.” On June 11, right-wing blogger Jim Hoft tweeted:

[Twitter.com, 6/11/13]                                                                                                                                                          

Right-Wing Media Have A History Of Misinforming On Contraceptives

Myth: Emergency Contraceptives Are Abortion Pills

Myth: Access To Contraceptives Increases Sexual Activity In Teens

Myth: Access To Contraceptives May Increase Number Of Abortions

Myth: Young People May Be Susceptible To Taking Plan B Incorrectly

Myth: Prolonged Use Of Oral Contraceptives Leads To Infertility

Myth: Emergency Contraceptives Are Abortion Pills

Drudge Report: “Obama Allows Morning-After Abortion Pill For Under-17s.” A June 11 Drudge Report tweet claimed that Plan B was a “morning-after abortion pill”:

[Twitter.com, 6/11/13]

Wash. Times: Judge Authorized Over-The-Counter Sales Of “The Plan B Morning-After Abortion Pill.” A Washington Times editorial featured the sub-headline: “Pssst! A government pusher's got abortion pills for children,” and led with the claim that Plan B is an abortion pill:

The Justice Department decided Wednesday to appeal a federal judge's order authorizing over-the-counter sales of the Plan B morning-after abortion pill without any age restrictions. [The Washington Times, 5/3/13]

Fact: A Wealth Of Scientific Evidence Shows That Plan B Cannot Stop Pregnancy After Fertilization Takes Place

NY Times: Emergency Contraceptives Work To Prevent Ovulation, Not Implantation.  As The New York Times reported, emergency contraception works to preempt pregnancy. By delaying ovulation, Plan B stops an egg from being released for fertilization. Some emergency contraceptives may also work to thicken cervical mucus to make it more difficult for sperm to swim. Plan B does not stop implantation after fertilization has occurred [emphasis added]:

Studies have not established that emergency contraceptive pills prevent fertilized eggs from implanting in the womb, leading scientists say. Rather, the pills delay ovulation, the release of eggs from ovaries that occurs before eggs are fertilized, and some pills also thicken cervical mucus so sperm have trouble swimming.

[...]

By 2007, scientific consensus was building that morning-after pills did not block implantation. In one study using fertilized eggs that would have been discarded from fertility clinics, Dr. Gemzell-Danielsson found that adding Plan B in a dish did not prevent them from attaching to cells that line the uterus.

Later, in 2007, 2009 and 2010, researchers in Australia and Chile gave Plan B to women after determining with hormone tests which women had ovulated and which had not.

None who took the drug before ovulation became pregnant, underscoring how Plan B delays ovulation. Women who had ovulated became pregnant at the same rate as if they had taken no drug at all. In those cases, there were no difficulties with implantation, said one of the researchers, Gabriela Noé, at the Instituto Chileno de Medicina Reproductiva in Santiago. Dr. Blithe of the N.I.H., said, “No one can say that it works to inhibit implantation based on these data.”  [The New York Times, 6/5/12]

NY Times: Claims That Emergency Contraceptive Pills Cause Abortion “Do Not Reflect What The Science Shows.” The New York Times reported that federally approved product labels and some medical websites have suggested that emergency contraception pills can prevent implantation of a fertilized egg, leading conservative politicians and religious activists to equate the pills with abortifacients. This claim was likely “rooted in outdated or incorrect scientific guesses about how the pills work,” The New York Times reported, and has since been debunked by numerous medical studies. The New York Times reported that, "[An] examination by The New York Times has found that the federally approved labels and medical Web sites do not reflect what the science shows." The Times further noted that an FDA spokeswoman Erica Jefferson acknowledged the findings, though she would not discuss the possibility of revising labels:

The emerging data on Plan B suggest that it does not inhibit implantation. Less is known about Ella. However, some data suggest it also does not inhibit implantation. [The New York Times, 6/5/12]

International Federation of Gynecology & Obstetrics: Emergency Contraceptives “Do Not Inhibit Implantation.” A 2012 statement by the International Federation of Gynecology & Obstectrics with a section titled “Do not inhibit implantation,” explained:

Two studies have estimated effectiveness of [emergency contraceptive pills] by confirming the cycle day by hormonal analysis (other studies used women's self-reported cycle date). In these studies, no pregnancies occurred in the women who took ECPs before ovulation; while pregnancies occurred only in women who took ECPs on or after the day of ovulation, providing evidence that ECPs were unable to prevent implantation. [International Federation of Gynecology & Obstetrics, March 2012]

Myth: Access To Contraceptives Increases Sexual Activity In Teens

Fox News' Martha MacCallum Pushed The Myth That Increased Access To Emergency Contraceptives “Encourage[s]” Underage Sex. On Fox News' America's Newsroom, co-host Martha MacCallum introduced a segment on the FDA's decision to expand access to Plan B as “something that critics argue could encourage sexual activity.” Later in the segment, she responded to a comment about teen sex by asking if access to Plan B would encourage teen sex. [Fox News, America's Newsroom, 5/3/13, via Media Matters]

Fox News' Andrew Napolitano Pushed Myth That Emergency Contraceptive Will “Encourage 15-Year-Olds To Have Sex.” On Fox & Friends, Fox News senior judicial analyst Andrew Napolitano used state efforts to limit access to emergency contraceptives to dispute the FDA's expanding Plan B access, claiming “states regulating for health, safety, welfare, and morality say well this isn't right, we don't want to encourage 15-year-olds to have sex”:

NAPOLITANO: The Constitution keeps the power in the states to regulate for health, safety, welfare, and morality. The Constitution also has given Congress the power to regulate interstate commerce. So these two things are clashing. Congress set up the FDA, and the FDA, the Food and Drug Administration, decides what drugs we can take and who can take them.

ALISYN CAMEROTA (co-host): Okay.

NAPOLITANO: So the FDA says girls as young as 15 can take the morning-after pill. The states regulating for health, safety, welfare, and morality say, well this isn't right, we don't want to encourage 15-year-olds to have sex. We think they should be older. So you have the right of the state to protect the morality of young women versus the right of the FDA to decide who can take the drugs, and they're going to clash and they're going to clash in a federal courtroom and a federal judge will make this decision.

[...]

Is there one size fits all declared by the FDA, no matter what the states want, no matter what the level of morality or need for education is? Or can this be done by state by state?" [Fox News, Fox & Friends, 5/2/13]

Fact: Research Shows Access To Emergency Contraceptives Does Not Increase Teens' Sexual Activity

Guttmacher Institute: Increased Access To Contraceptives Does Not Correlate With Increased Sexual Activity In Teens. A 2012 Guttmacher Institute study “interviewed a nationally representative sample of teens from June 2006 to June 2008, and again from July 2008 to July 2010.” During those periods, it found no correlation between increased contraceptive use and sexual activity:

While there was no significant change over those years in the overall proportion of females aged 15-19 who were sexually experienced or engaging in sexual activity, there was a dramatic shift in teen contraceptive use. [Guttmacher Institute, 4/11/12]

Reuters: Seven Studies Found Access To Morning-After Pill Did Not Increase Teens' Sexual Activity. A Reuters article on the American Academy of Pediatrics' decision to support increased access to emergency contraceptives for teenagers explained that, "[a] 2010 analysis of seven randomized studies of emergency contraception found that having a morning-after prescription in hand did not increase teens' sexual activity or decrease use of standard contraceptives but did increase use of the pill and shorten the time before a teenager used it after sex." [Reuters, 11/26/12]

Bixby Center: Research Shows No Evidence Of A Link Between Emergency Contraceptives (EC) And Sexual Risk-Taking. The Bixby Center for Global Reproductive Health at the University of California, San Francisco found that emergency contraception does not promote sexual risk-taking, and that instead, “a substantial body of research demonstrates that there is no relationship between availability of EC and increased sexual risk behavior”:

Though emergency contraception (EC) is only intended for occasional use, concerns have been raised that increasing access to EC (e.g., by making it available without prescription over-the-counter) would lead to increased sexual risk-taking. For example, if EC was easily accessible, would women use contraception less regularly, more readily engage in casual sex, or be at increased risk of contracting STIs? There is no scientific evidence to substantiate these concerns. To the contrary, a substantial body of research demonstrates that there is no relationship between availability of EC and increased sexual risk behavior.

[...]

A key study found that women who received advance provision of EC did not have sex more frequently than other women, nor did they have greater numbers of sexual partners, behaviors that can increase the risk of contracting an STI ... In fact, the majority of women in the study had only one partner, regardless of whether or not they received advance provision of EC. Moreover, levels of STIs, such as chlamydia and herpes, were similar across women in the study ... indicating that improved availability of EC does not affect STI risk. Women receiving advance provision of EC have also reported that having EC on hand does not influence their decision-making with regard to unsafe sex or exposure to STIs. [Bixby Center for Global Reproductive Health, University of California, San Francisco, April 2008]

Princeton University: Studies Show That Access To Emergency Contraceptives And Education Does Not Increase Teen Sexual Activity. Research published by Princeton University on emergency contraceptives explained that while there is some disagreement in the scientific literature, two studies had shown that “Teens receiving emergency contraception supplies in advance ... did not report higher frequencies of unprotected sex,” and “educating teens about ECPs does not increase their sexual activity levels”:

[T]eens receiving emergency contraception supplies in advance were more likely to use ECPs when needed but did not report higher frequencies of unprotected sex, did not use condoms or hormonal contraception less often, and did not exhibit higher rates of STIs. Another study demonstrated that educating teens about ECPs does not increase their sexual activity levels or use of EC but increases their knowledge about proper administration of the drugs. [Princeton University, May 2013]

Myth: Access To Contraceptives May Increase Number Of Abortions

National Review Online: Increased Contraceptive Access May “Make Abortions More Likely.” The National Review Online's Michael J. New claimed that increased access to contraceptives could “change individual incentives in ways that will make abortions more likely” and suggested that “increased access to contraceptives often fails to reduce the unintended-pregnancy rate.” [National Review Online, 5/7/13]

Fact: Studies Show Access To Contraceptives Decreases Abortions Worldwide And Attribute Decline In U.S. Teen Birth Rates To Contraception, Not Abortion

Guttmacher Institute: “Contraceptive Use Is Key to Reducing Abortion Worldwide.” A 2003 report from the Guttmacher Institute titled “Contraceptive Use is Key to Reducing Abortion Worldwide,” found "[e]xtensive evidence" that access to contraceptives “replaces previous reliance on abortion and becomes the major factor associated with reduced abortion rates” worldwide. The report included these graphs:

[Guttmacher Institute, October 2003]

Guttmacher Institute: Teen Births at Record Low Due “Almost Exclusively” To Contraceptive Access. A Guttmacher Institute analysis of Center for Disease Control (CDC) data identified a 44 percent drop in teen birth rates between 1991 and 2010. The report attributed this decline “almost exclusively” to improvements in teen contraception access.

The most recent decline in teen births can be linked almost exclusively to improvements in teens' contraceptive use, according to data from another CDC survey, the National Survey of Family Growth (NSFG). The NSFG interviewed a nationally representative sample of teens from June 2006 to June 2008, and again from July 2008 to July 2010. While there was no significant change over those years in the overall proportion of females aged 15-19 who were sexually experienced or engaging in sexual activity, there was a dramatic shift in teen contraceptive use. [Guttmacher Institute, 4/11/12]

Myth: Young People May Be Susceptible To Taking Plan B Incorrectly

Wash. Times: Claims Of Plan B's Safety Are Not “Credible” If Young Girls Can Access “A Powerful Drug” Without “Mature Guidance.” The same May 3 Washington Times editorial that claimed that Plan B resulted in abortions, called the claim that young women would properly know how to use  the contraceptive “dubious”:

“There have been no studies on the drug's effect on young girls,” says Anna Higgins, director of the Family Research Council's Center for Human Dignity. "[Over-the-counter] sales could encourage repeat use, which is unsafe." FDA Commissioner Margaret A. Hamburg insists that “women 15 years of age and older 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.” This is a dubious claim, even less credible when applied to girls 12 years old or younger who can walk out of a pharmacy with a powerful drug without the mature guidance of a physician or other adult. [The Washington Times, 5/3/13]

Fact: Research Shows Most Females Ages 11 To 17 Take Plan B One Step Correctly And Experience Minimal Side Effects

Kaiser Permanente Researchers: Regardless of Age, Most Females 11 to 17 Use Single-Tablet Emergency Contraception Correctly. Kaiser Permanente's Division of Research studied the use of a one-pill emergency contraceptive by females between the ages of 11 and 17 in simulated over-the-counter situations. About 91.5 percent of participants used the pill correctly as labeled, and younger participants were no likelier to misuse the pill than older ones. The study identified no adverse effects. [US National Library of Medicine, April 2012]

FDA: Center For Drug Evaluation Research (CDER) Determined That Young Women Understood How To Use Plan B Safely. Before approving Plan B for over-the-counter distribution, the CDER, an FDA agency, conducted research to conclusively determine whether 15-year-olds were able to understand the use and side effects of the medication. As FDA Commissioner Margaret Hamburg, MD explained [emphasis added]:

The Center for Drug Evaluation and Research (CDER) completed its review of the Plan B One-Step application and laid out its scientific determination. CDER carefully considered whether younger females were able to understand how to use Plan B One-Step.  Based on the information submitted to the agency, CDER determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider. [FDA, 12/7/11]

Myth: Prolonged Use Of Oral Contraceptives Leads To Infertility

Fox's Laura Ingraham: Using Birth Control Can Lead To Infertility. On the May 5 edition of The Laura Ingraham Show, host Laura Ingraham cast doubts on the safety of oral contraceptives:

INGRAHAM: Contraception for 12-year-olds, hell in a handbasket,

[...]

Oh they're perfectly safe, you know, just tell all the women that were on the birth control pill for like 15 years how easy it is to get pregnant after being on the birth control for 15 years. They are telling you a lot of things about -- that women messing up their hormonal balance, their natural balance in their body. It's just oh it's just: 'oh it's no risk, no risk, no risk at all.' [The Laura Ingraham Show, 5/6/13]

Fox's Martha MacCallum Suggested Plan B Could Hurt Future Fertility. On the May 1 edition of America's Newsroom, MacCallum stoked fears about Plan B: “Who knows what the long-lasting implications of using it in that way are? When this girl decides she wants to have a baby a few years down the road?” [Fox News, America's Newsroom, 5/1/13, via Media Matters]

Fact: Studies Show That Birth Control Does Not Impede Fertility Later In life

CBS News: “Study: Past Pill Use Won't Lower Fertility.”  A CBS News article titled “Study: Past Pill Use Won't Lower Fertility” reported on a 2003 study that found no correlation between prolonged use of oral contraceptives and later infertility. In her presentation before the 55th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists, researcher Maureen Cronin, M.D., Ph.D. mentioned the common misconception that hormonal contraceptive may lead to higher rates of infertility.  “We did the study to lay the question to rest,” she said. As CBS reported:

One cycle after stopping the pill, 21.2 percent of the women were pregnant, Cronin found. This is comparable to the naturally occurring pregnancy rate per cycle, which experts say is between 20 percent and 25 percent.

A year after stopping the oral contraceptives, 79.4 percent of the women were pregnant; again the rate corresponds with those reported in women planning a pregnancy who had not used the pill.

[...]

Nor did long-term use of the pill have a major impact on fertility, Cronin's team found. While 79.3 percent of women on the pill less than two years became pregnant in the year after stopping it, 81 percent of women on the pill more than two years got pregnant in the first year after stopping it. [CBS News, 6/8/07]

Misinformation About Contraception Is Harmful To Young Adults

Guttmacher Institute: Myths, Lack Of Education Are Associated With Risky Contraceptive Behaviors. According to the Guttmacher Institute, myths about contraceptives can have a detrimental impact on young adults, leading to unplanned pregnancy:

Fear of side effects, norms and attitudes that favor nonmarital pregnancy or undervalue the importance of contraception, pregnancy ambivalence and mistrust of government's role in promoting contraception were also associated with one or more risky contraceptive use behaviors. [Guttmacher Institute, June 2012]