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Health

OB-GYNs Are Confused By The Political Fight To Restrict Emergency Contraception

This month, the political fight over emergency contraception has intensified, as the Obama administration continues to resist making the morning after pill available to women of all ages over the counter. After a federal judge ordered the FDA to remove all age restrictions on emergency contraception, the administration disagreed, maintaining that girls under 15 years old should still be required be obtain a prescription to purchase the contraceptive method — a position that baffles medical experts.

At the American Congress of Obstetricians and Gynecologists’ recent annual meeting, MedPage Today asked women’s health experts what they thought of the ongoing fight over Plan B. Multiple medical experts went on record to say that they don’t understand why emergency contraception has been such a contentious issue, and they don’t support restricting it for younger teens:

Owen Montgomery, MD: “I would much rather have a 13- to 14-year-old girl who needs emergency contraception have access to it than come to my office with an unwanted pregnancy… In our clinics in the university, we see lots and lots of teenagers. And many of these young ladies have no access to good parental role models, and they need access to emergency contraception when they need access. And they can’t wait for permission from a judge, or someone else of authority.”

Alison Edelman, MD, MPH, of Oregon Health & Science University: “Emergency contraception is a really, really important part of our toolkit for contraception. It helps women who have emergencies, i.e., they aren’t using contraception at the time of sexual activity or they had a misstep with their contraception, like a condom break or slip.”

Barbara S. Levy, MD, ACOG’s vice president for health policy: “There’s failure of other methods. There are rapes. There are other things that occur. Women need to be able to access emergency contraception and have the knowledge and understanding of how to use it, so we can prevent unwanted pregnancies and unintended pregnancies that happen, because life happens.”

Laurie J. McKenzie, MD, of both the University of Texas and Baylor College of Medicine: “I find it very interesting that there are these concessions that are being made in terms of age limitation … There are more deaths associated with Tylenol overdose than there are with oral contraceptive overdoses or potential overdose with Plan B. There have never, to my knowledge, been any overdoses with hormonal contraception.”

Eve Espey, MD, MPH, of the University of New Mexico in Albuquerque: “Plan B should be over the counter… All emergency contraceptives should be over the counter with no age restrictions.”

Indeed, there’s no scientific basis for imposing an age limit on Plan B. Multiple medical groups, including the American Academy of Pediatrics, have expressed support for making emergency contraception easily accessible to women of all ages.

Health

Judge Slams FDA’s ‘Sweetheart Arrangement’ With Big Pharma That Limits Access To Morning After Pill

In a fiery decision on Friday, U.S. District Judge Edward Korman denied the Obama administration’s motion to delay an order to immediately allow over-the-counter access to emergency contraception to women of all ages. After Korman initially ordered in April that the so-called “morning-after pill” be available to all women and girls without a prescription, the FDA instead decided to lower the age limit to teens 15 and up rather than 17. However, those 15- and 16-year-olds will only have over-the-counter access to one brand of emergency contraception pill, Teva Pharmaceutical’s Plan B One-Step, thanks to what Korman called a “sweetheart arrangement” between the FDA and Teva.

Blasting the Obama administration’s argument as “an insult to the intelligence of women,” Korman attacked the FDA’s decision to lower the age restriction for Plan B rather than comply with his order to allow all women access to any brand of emergency contraception. The judge accused the administration of delaying his ruling so as to give Teva Pharmaceutical sole access to the market of 15- to 17-year olds without a prescription. Generic versions of Plan B, meanwhile, will stay behind the pharmacy counter for this age group.

Korman also noted that Teva will drive up the price of the pill now that it has a monopoly on young women in need:

While this proposal was a boon to Teva, it did little to eliminate the practical obstructions in obtaining emergency contraception to women of child-bearing age whether over or under age 15. On the contrary, Teva will use its privileged marketing status and exclusivity to increase the cost of the drug. The price of Plan B One-Step under the new marketing regime is expected to be $60, significantly more than the one- or two-pill generic version, and could conceivably go higher, if only to accommodate the more expensive packing, age-verification tags, and anti-theft technology that the new marketing arrangement would require.

As Teva profits from the Obama administration’s arbitrary age restriction, the burden on women seeking emergency contraception will only grow larger. Younger teens and undocumented women unable to prove their age with government-issued ID will still not have access, and may not be able to afford the new cost. As Korman points out, the Teva-FDA deal still requires Plan B to be sold over the counter at stores with on-site pharmacies, even though many women do not live near such facilities. The decision also cites a survey of 943 pharmacies in 5 cities, which found that only 4.7 percent stayed open 24 hours. Given the time-sensitive and often urgent need for emergency contraception, limiting the hours and locations where women can buy the drug could have serious consequences.

Moreover, there is no medical reason to limit access to the morning-after pill. Despite the Obama administration’s concern that it could be “dangerous” to young teens, an enormous body of research has demonstrated emergency contraception is safer than aspirin for women of all ages.

Health

Judge Mocks Obama Administration’s Attempt To Restrict Morning After Pill As ‘A Charade’

U.S. District Judge Edward Korman did not take well to the Obama administration’s appeal of the judge’s recent order to lift all age restrictions on the Plan B “morning-after pill.” In his original ruling last month, Korman chided the administration for its “political interference” into the FDA’s recommendation to allow women of all ages to obtain emergency contraception without a prescription. On Tuesday, the federal judge did not hesitate to express his displeasure once again, calling the Justice Department’s appeal “a charade.”

During a hearing in Brooklyn, Korman accused the administration of trying to “sugarcoat this appeal of yours” to hide their true attempt to stall the court order. Though the court’s ruling is not expected until the end of the week, Korman made his outrage over the “total and complete corruption of the administrative process” quite clear:

When the government lawyer argued that delaying Korman’s order while it was on appeal was in the public interest, the judge responded, “Is there a public interest in unwanted pregnancies … that can often result in abortions?”

The judge also expressed outrage at another provision under the new FDA rules that would require government-issued photo identification to get the pills, placing an “impossible burden” on disadvantaged people without IDs.

“The poor, the young and African-Americans are going to be put in the position of not having access to this drug,” he said.

Making the same point earlier, he asked, “Is that the policy of the Obama administration?”

Korman also speculated that the FDA’s new policy restricting Plan B for girls under 15 instead of under 17 was intended to undermine his ruling, which would have removed all limits on the drug’s availability this week. Indeed, the Obama administration’s apparently arbitrary age limits have no basis in scientific research. Multiple studies have found Plan B to be safer than even aspirin for all ages. Moreover, making women prove their age before buying Plan B creates an unnecessary burden for undocumented women and teens who don’t have government-issued documents. Women’s advocacy organizations erupted in protest over Obama’s decision to appeal the court order to remove these limits.

Health

Fox News Commentator: Stop Abortions By ‘Celebrating’ Teen Pregnancy

A Fox News contributor denounced the “culture” of abortion on Fox News Sunday, claiming there is a “stigma” against teenagers who carry babies to term and give them up for adoption. In a discussion about the current Plan B controversy, Nina Easton of Fortune Magazine conceded that expanding access to birth control is an effective way to reduce abortions. However, she quickly pivoted to the need to “celebrate” young girls who carry pregnancies to term for adoptive parents:

I do think there’s a case to be made for conservatives or anybody who cares about the rate of abortions in this country to deregulate birth control more, although I also understand a need for parents to be involved. One of the things out of all of this news, including the president’s speech to Planned Parenthood and this Gosnell case of murdering babies, is we’re looking at a culture that produces 1.2 million abortions a year. We’re losing sight of that fact. I would say that in addition to deregulating birth control, another thing we need to do is celebrate young women who bring a baby to term and find an adoptive parent. There’s such a stigma today to being an adoptive birth mom that you’re more willing to admit that you’ve had an abortion than that you are delivering a healthy newborn to a loving family. What’s wrong with our culture that that’s where we are today?

Watch it:

Easton offered up Obama’s speech to Planned Parenthood and the Gosnell trial as evidence of how young women who choose to carry babies to term for adoption are being stigmatized. While it’s true that only 1 percent of single pregnant women choose adoption, Easton glosses over the difficulty involved in maintaining a normal life for 9 months as a pregnant teenager. Moreover, birthmothers under 17 are more likely to change their minds about the adoption and keep the baby, making them vulnerable to dropping out of high school and a permanent cycle of poverty that entraps the majority of teen moms. While adoption can be a good option for many pregnant women, Easton’s suggestion that teen pregnancy should be celebrated while abortion should be stigmatized is playing with fire.

Meanwhile, teen pregnancies are at their lowest rate in 40 years, thanks to expanded birth control and abortion access.

Health

Fox News Freaks Out Over Obama’s Plan B Decision: Teen Sex Is ‘Criminal Behavior’

On Friday morning, Fox News anchor Martha MacCallum bemoaned the FDA’s recent decision to lower the age restriction on over-the-counter Plan B from 17 to 15 years old. MacCallum and her guest, Republican strategist Brad Blakeman, falsely asserted that easing access to emergency contraception would increase teens’ rates of sexual activity, and suggested that the government is condoning “criminal behavior” among minors.

In order to justify denying contraceptive resources to American teens, Blakeman attempted to construe consensual sexual relationships between minors as criminal activity. Even though state law typically defines statutory rape as a sexual relationship between two individuals with a significant age gap, Blakeman claimed that sexually active 15-year-olds are always engaging in statutory rape, and allowing them to purchase Plan B over the counter is simply condoning this illegal behavior:

BLAKEMAN: This makes no sense at all. You have to be 18 years old to buy a pack of cigarettes, and the president is also encouraging criminal behavior, because in most jurisdictions in America engaging in sexual intercourse at 14, 15 years old is statutory rape. The president is somehow saying in if you engage in that activity, criminal behavior, that is okay because the government is going to provide you the out for your bad decision making. [...]

MACCULLUM: We had Dr. Manny Alvarez here the other day, and he, you know, has delivered thousands of babies, he’s an obstetrician, a gynecologist. He was so upset about this. You know, he said, they are giving them out like candy. He said there are college students who think that this is the — that this is contraception, it’s what they use, the day after pill in order to, you know, as a matter of course in their lives. Does that not trouble you?

BLAKEMAN: This strips away the moral fabric of our country. It’s the government basically being complicit in a criminal act. And also complicit in coming into the houses of America and telling the parents, you’re — we are bringing to bring up your children. We’ll be able to provide better for your decisions than the decisions you may make at home. I think it’s an outrage, but it’s the modus operandi of this administration. [...] Should we decriminalize statutory way up and say if you’re 15, go out and have sex as a matter of law?

Watch it:

The idea that consensual sexual activity among minors is inherently “criminal” is common viewpoint among conservative groups. Earlier this year, the right-wing Family Research Council suggested that unmarried people should be denied birth control and punished for having sex. This attitude helped fuel the abstinence-only movement in the 1990s, which has prevented students across the country from learning accurate information about sexual health resources and has contributed to epidemic levels of STD infections and teen pregnancy rates.

But, contrary to Fox News’ dramatic assertions, studies have shown that providing teens with access to Plan B does not actually increase their sexual activity. In fact, easing young adults’ access to emergency contraception simply helps prevent unintended pregnancies and abortions, which is why it’s a public health policy that has support from prominent medical experts — including the American Academy of Pediatrics.

Health

President Obama Defends Age Restrictions On Over-The-Counter Emergency Contraception

(Credit: WOWKTV)

Earlier this week, the Obama administration announced that it will fight to maintain age restrictions on over-the-counter Plan B sales, appealing a U.S. federal judge’s recent ruling that ordered the FDA to make that type of contraceptive available to all women without a prescription. The FDA recently lowered the age threshold for over-the-counter sales from 17 to 15, and President Obama said on Thursday that he supports continuing to restrict Plan B for girls younger than 15.

“I’m very comfortable with the decision they’ve made right now based on solid scientific evidence for girls 15 and older,” Obama said at a press conference on Thursday afternoon. That’s consistent with the administration’s previous claims that Plan B could be too “dangerous” for young women to use correctly.

But — despite Obama’s misleading reference to “solid scientific evidence” — that position isn’t actually backed by science. In fact, multiple prominent doctor’s groups and medical experts have confirmed that emergency contraception is safe for teens of all ages to use. The morning after pill is safer than aspirin. That’s why the FDA approved it for over-the-counter use for all ages back in 2011. The only reason that the agency amended its policy to impose an age restriction is because the Obama administration stepped in to overrule the FDA — a political overreach that wasn’t based on the scientific evidence, but rather signaled a decision to disregard it.

In reality, the fight to limit over-the-counter sales of Plan B is more related to social pressures than it is to scientific evidence. Paternalistic attitudes toward teen sexuality have led many Americans to favor restricting sexual health resources for youth. But, as the American Academy of Pediatrics points out, allowing younger teens to have access to the birth control resources they need is actually a safer public health policy than enacting an unnecessary age restriction, since it can help prevent unintended pregnancies and abortions among young girls. The United States continues to have one of the highest rates of teen pregnancy in the developed world.

Both women’s health groups and anti-abortion activists have been critical of the Obama administration’s emergency contraception policy. Perhaps in an attempt to distance himself from the ongoing controversy, the president noted on Thursday that the FDA is ultimately outside of his purview. “It’s not my decision to make,” Obama said. “The first time around, where there were no age restrictions, Secretary Sebelius expressed concerns and I supported those concerns and I gave voice to them.”

Health

Women’s Health Groups Slam Obama Administration’s Fight To Maintain Age Restrictions On Plan B

Late Wednesday evening, the Obama administration announced that it will appeal a recent court decision that ordered the FDA to make emergency contraception available to all women over the counter. Last month, U.S. Judge Edward R. Korman gave the administration 30 days to lift the current age restrictions on over-the-counter Plan B, saying the decision to require younger teenagers to obtain a prescription for the FDA-approved contraceptive amounted to “political interference.”

The Department of Justice believes Korman overstepped his authority by ordering a federal agency to change its policy without allowing more time for internal review. Earlier this week, the FDA announced that it will lower the age restriction from 17 to 15, a policy change that is unrelated to last month’s court ruling. The Obama administration’s decision to appeal is a sign that it will stand by that new rule.

But the women’s health groups that have long advocated for expanded access to emergency contraception — which prominent medical groups confirm is safe for girls of all ages — are unhappy with what they perceive as a “step backwards.” Since there is no scientific basis for age restrictions on Plan B, reproductive rights leaders argue that the White House is simply insistent on playing politics to impose an unnecessary burden on young women:

– SUSANNAH BARUCH, INTERIM PRESIDENT AND CEO OF THE REPRODUCTIVE HEALTH TECHNOLOGIES PROJECT: “This appeal takes away the promise of all women having timely access to emergency contraception. It is especially troubling in light of the Food and Drug Administration’s move yesterday to continue age restrictions and ID requirements, despite a court order to make emergency contraception accessible for women of all ages. Both announcements, particularly in tandem, highlight the administration’s corner-cutting on women’s health. It’s a sad day for women’s health when politics prevails.”

– NANCY NORTHRUP, PRESIDENT AND CEO OF THE CENTER FOR REPRODUCTIVE RIGHTS: “The federal court has made clear that these stalling tactics were based purely on politics, not science. We are deeply disappointed that just days after President Obama proclaimed his commitment to women’s reproductive rights, his administration has decided once again to deprive women of their right to obtain emergency contraception without unjustified and burdensome restrictions.”

– CECILE RICHARDS, PRESIDENT OF PLANNED PARENTHOOD FEDERATION OF AMERICA: “The Obama administration took an important step forward earlier this week by moving emergency contraception out from behind the pharmacy counter and making it available to people ages 15 and older, and we continue to believe that access should be expanded further.”

– TERRY O’NEILL, PRESIDENT OF THE NATIONAL ORGANIZATION FOR WOMEN: “The prevention of unwanted pregnancy, particularly in adolescents, should not be obstructed by politicians…President Obama should practice what he preaches.” She called the decision to appeal a “step backwards for women’s health.”

– ILYSE HOGUE, PRESIDENT OF NARAL PRO-CHOICE AMERICA: “When Judge Korman’s ruling came down, we welcomed it as an affirmation that policy can and should be driven by facts and delivered with the public health in mind. Unfortunately, today’s appeal reminds us that sometimes our leaders are out of step with the reality women face every day. We can only assume that HHS is signaling that they are satisfied with the status quo. That’s simply unacceptable.”

Conservative groups, on the other hand, applauded the decision to appeal — but still found some fault with the administration’s Plan B policy, which they believe is too lax. Marjorie Dannenfelser, the president of the anti-abortion Susan B. Anthony List, noted, “While we agree with the administration’s decision to appeal Judge Korman’s ruling, it is troubling that Secretary Sebelius is ‘satisfied’ with the FDA’s decision to endanger the lives of teen girls. Whether they are 15 or 17, teens need the protection and support that comes with parental and doctor involvement…The administration is moving in the wrong direction if they seek to set an underage standard.”

Health

Why Limiting Over-The-Counter Plan B To Girls Over 15 Is Still An Ineffective Policy

(Credit: Boston Globe)

On Tuesday, the FDA announced that it will lower the age restriction on over-the-counter emergency contraception sales, allowing teens 15 years old and up to purchase Plan B without a prescription. Currently, only those 17 and older can buy this type of contraception over the counter. The new FDA guidelines will also move Plan B onto pharmacy shelves next to the condoms; previously, it was kept behind the counter and those who wanted to purchase it had to ask a pharmacist to retrieve it.

As Planned Parenthood noted in a statement on Tuesday, removing the restrictions on Plan B for 15- and 16-year-olds is certainly a step in the right direction in terms of expanding access to birth control. But, even though the age has been lowered, maintaining an unnecessary age restriction on over-the-counter sales is still a policy that ultimately undermines women’s health. Here’s why the FDA’s new policy is still problematic:

– It still isn’t based in science. There’s no scientific reason to impose age restrictions on Plan B. In fact, back in 2011, the FDA determined that the contraceptive can be used safely by girls and women of any age. Nevertheless, the Department of Health and Human Services overruled the FDA to restrict Plan B for Americans under 17 years old — a move that a U.S. federal judge recently criticized as “political interference.” Studies have shown that Plan B is safer than aspirin, which is obviously available for purchase over the counter for people of any age. Multiple medical groups have come out in favor of making emergency contraception available to all women over the counter. The continued efforts to police it — earlier this month, the Obama administration falsely asserted that Plan B could be too “dangerous” for young women to take correctly — seem to be based in paternalism rather than in actual scientific fact.

– It imposes an additional burden on women of every age who will have to provide proof of age. When the old FDA guidelines restricted emergency contraception for those under 17, it created issues even for those who were well above the age limit. Women’s health advocates argue that this type of age restriction perpetrates a stigma that makes it harder for everyone to access Plan B, as pharmacists often falsely tell older women they may not purchase emergency contraception without a prescription or incorrectly deny Plan B to men. And requiring women to prove their age — the new Plan B packaging will include a product code that prompts the cashier to verify the customer’s age — could present a significant hurdle for women who don’t have ID on them.

– It leaves out undocumented women and potentially younger teens. Undocumented immigrant women do not necessarily have the proof of age that the FDA stipulates is required under its policy, like a driver’s license, a passport, or a birth certificate. Even the immigrant women who are much older than 17 may not be able to purchase emergency contraception if the cashier insists on seeing one of those government-issued documents. And younger teens who may not have a license or a passport, which could apply to many 15-year-olds, will be denied emergency contraception. “If a 15-year-old is unable to verify their age, they will not be able to purchase Plan B One-Step,” an FDA spokeswoman told the Washington Post.

– It doesn’t fully address a recent ruling that the FDA must make Plan B available to all women over the counter. The FDA clarified that Tuesday’s announcement is completely unrelated to a recent court decision that ordered the agency to remove all age restrictions for Plan B. At the beginning of April, a federal judge ruled that the FDA must make emergency contraception over the counter for all women. The Obama administration has four days left to decide whether to comply with that ruling or appeal it. This separate announcement may be seen as somewhat of a compromise, but since it’s not actually in response to that judge’s order, it doesn’t really do anything to address that pending legal issue.

Another unresolved issue with the Obama administration’s Plan B policy is the matter of insurance coverage. Obamacare requires insurers to cover all FDA-approved contraceptives without charging a co-pay, and that includes over-the-counter emergency contraception. But as the policy stands now, women must still have a prescription from their doctor in order to get insurance coverage for the birth control that they purchase over the counter — without that prescription, they have to pay for it out of pocket. Many women, particularly younger teens, may not be able to afford the full cost of Plan B, which is typically around $50. But requiring them to get a prescription for this time-sensitive medication often defeats the point.

Update

The American College of Obstrecians and Gynecologists has released a statement in response to the FDA’s new policy. The group of medical experts commends the FDA’s attempt to expand access to emergency contraception for teens, but reiterates that “the medical evidence demonstrates that EC is safe and effective in preventing pregnancy for all reproductive-age females” and “the College strongly encourages the FDA to reaffirm its earlier decision to approve EC for unrestricted over-the-counter access.”

Health

New Federal Guidelines For Sexual Assault Cases Could Expand Rape Victims’ Access To Plan B

For the first time in the past seven years, the federal government has issued specific guidelines for the way that health professionals, law enforcement officers, and prosecutors should respond to sexual assault cases. And unlike the earlier guidelines issued in 2004, the new policy specifically recommends methods to prioritize victims’ “physical and emotional needs,” including ensuring that emergency contraception is available to them.

The new national protocol intends to standardize the practice of collecting evidence and treating victims who have been the subject of sexual violence — a method of bolstering the advances made by the Violence Against Women Act over the past 18 years. Except for the medical professionals working in federal prisons or in the military, who will be required to follow them, the guidelines are voluntary. Still, advocates working to assist victims of sexual assault are praising the new policy as an important update to the 2004 rules:

Unlike the 2004 protocol, the new guidelines also recommend that rape victims be offered emergency contraception or — in cases where health professionals have moral objections — information on how to immediately obtain the medication.

The earlier guidelines “were not nearly so direct,” said Barbara Sheaffer, medical advocacy coordinator for the Pennsylvania Coalition Against Rape, which receives some financing from the Justice Department. [...]

Sgt. Jim Markey, a former sex crimes investigator for the Phoenix Police Department who now trains law enforcement officers in dealing with sexual assault, said the new guidelines were “long overdue.”

“What this does is this allows workers in the trenches, those victim advocates, those detectives and nurses, to go to the decision makers and leaders in their communities and say: ‘You know what? Here are the standards. We need the resources to provide the minimum standards that are in this protocol.’ ”

It’s important that the guidelines not only recommend making Plan B readily accessible, but also specify that the medical professionals who personally object to emergency contraception should still provide victims with information about where else to obtain it. Over the past year, there have been several incidences where rape victims have been denied the morning after pill at hospitals or jails after employees there cited their religious objections to the contraceptive.

However, there’s still more work to be done on the state level. Currently, just 16 states and the District of Columbia have enacted legislation that requires medical professionals to provide survivors of sexual assault with Plan B. In other states, Republican lawmakers have blocked similar proposals to help ensure rape victims’ access to emergency contraception.

Health

The Most Effective Form Of Birth Control Is (Still) Safe For Teenagers

Intrauterine devices (IUDs), the most effective form of birth control, are a safe contraceptive method for teenagers, new research published by the American College of Obstetricians and Gynecologists last week confirms.

Examining health insurance claims for more than 90,000 women who had an IUD inserted between 2002 and 2009, the study found serious complications occurred in less than 1 percent of patients, regardless of IUD type or age, and concluded:

The IUD is as appropriate for teenagers to use as it is for older women, with serious complications occurring infrequently in all groups. The levonorgestrel-releasing intrauterine system may be a better choice than a copper IUD as a result of lower odds of complications, discontinuation, and failure.

IUDs are the most effective long-term birth control available. Although their somewhat higher upfront costs have historically limited women’s awareness and usage of the devices, Obamacare’s no-cost sharing for preventative care is helping fix that problem by eliminating co-pay costs required of patients.

The American College of Obstetricians and Gynecologists has previously recommended IUDs for sexually active teenagers, arguing that younger women are best suited for long-term contraceptives because the majority of teen pregnancies are unintended. Unfortunately, parental attitudes towards the IUDs have not kept up with medical opinions, with just 18 percent of parents saying they would be comfortable with their teen’s doctor giving them one in a study published earlier this year.

IUDs are not the only reproductive health advance where public perception has gotten in the way of medical science: Although the Food and Drug Administration (FDA) determined that Plan B (also known as the morning after pill) is safe for teenagers to use without the intervention of a healthcare provider, Health and Human Services (HHS) Secretary Kathleen Sebelius countermanded an order to make it available to people under the age of seventeen without a prescription in 2011.

Last week, a Reagan-appointed federal judge ordered that the FDA remove current age restrictions, pointing out that the Plan B — which is not an abortifacient — is “among the safest drugs sold over the counter.” Despite these developments and support from medical professionals for changing the policy, the Obama administration continues to claim Plan B could be “dangerous” for teen use.

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