Critics and Supporters React To Decision to Expand OTC Access to Plan B

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On Tuesday, the FDA announced that the Plan B morning-after pill will move out from behind the counter and be available for girls ages 15 and older without a prescription.


Update: The story has been updated to reflect the FDA’s decision to appeal a court order requiring the agency to make Plan B available to all women without a prescription.

The decision comes after Judge Edward Korman of the District Court of Eastern New York overturned Health and Human Services (HHS) Secretary Kathleen Sebelius’ ruling to put an age limit on obtaining Plan B without a prescription. In 2011, the Food and Drug Administration recommended that all women be allowed to access Plan B, a form of emergency contraception, without prescription. At the time, Plan B was available over-the-counter only to women aged 17 or older. But Sebelius overruled that proposal, and questioned the safety of having young girls taking the drug, which contains higher doses of the same synthetic hormone found in birth control pills, on their own.

Under the FDA’s new ruling, Plan B will now be available next to condoms and other reproductive health products, for girls to pick up off the shelves without engaging a pharmacist. The packaging will contain a code that alerts cashiers to ask for proof of age from anyone purchasing the drug.

(MORE: Judge Orders Morning After Pill Be Available Without Prescription, Without Restrictions)

Reproductive rights groups sued the government following Sebelius’ decision, which led to Judge Korman’s ruling on April 5 to make Plan B available over-the-counter without restrictions to all women. In making his argument, Judge Korman said Sebelius’ ruling was made in “bad faith and improper political influence,” writing in his decision, “it is hardly clear that the Secretary had the power to issue the order, and if she did have that authority, her decision was arbitrary, capricious, and unreasonable.” Korman gave the FDA 30 days to lift the current restrictions, but the FDA says the new approval was independent of the judge’s order, and resulted from an already pending application from Teva that requested its product be made available over-the-counter for women aged 15 or older. However, FDA Commissioner Dr. Margaret A. Hamburg briefed Sebelius about the review process and the amended Teva application, and Sebelius felt the new decision addressed her concerns, according to the HHS.

(MORE: Plan B: 1 in 5 Pharmacists May Deny Eligible Teens Access to Emergency Contraception)

“Research has shown that access to emergency contraceptive products have the potential to further decrease the rate of unintended pregnancies in the United States. The data reviewed by the agency demonstrated 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,” said Hamburg in a statement.

The FDA also filed an appeal to reverse Judge Korman’s ruling, and a spokesperson said the Department of Justice asked the court to prevent any changes in the current policy from taking effect during the appeals process.

(MORE: University Vending Machine Dispenses Morning-After Pill)

In the meantime, the FDA’s ruling on Teva’s application is likely to fuel the debate over who should have access to Plan B. While advocates see greater access to emergency contraception as an important component in fighting teen pregnancy and enhancing women’s reproductive rights, others are concerned about the implications of putting important reproductive decisions in the hands of girls as young as 15. Below are some responses to the FDA’s approval.

Dr. Jim Sears, board-certified pediatrician and co-host of The Doctors:

“While the numbers are improving, unplanned teen pregnancy remains a big concern in the U. S. The FDA’s new policy allowing teens as young as 15 to purchase the over-the-counter morning-after pill may have a significant impact on bringing those numbers even further down. I want to stress that simply because a drug is available over-the-counter, it does not necessarily mean that taking it is without risk. This is perfect opportunity for parents who may have avoided the topic to have a real discussion with their teens, both girls and boys, about the risks involved when it comes to sex. The morning-after pill should not be used as a primary method of contraception.”

Cecile Richards, President of Planned Parenthood Federation of America:

“While there are still practical questions to resolve, this decision will eliminate some of the biggest barriers and hurdles that women face in getting emergency contraception when they need it, which means many more women will be able to prevent unintended pregnancy. Emergency contraception is a safe and effective form of birth control that can prevent pregnancy if taken within five days of unprotected sex.

“While we fully support this expansion of access to birth control, we continue to believe that the administration should lift all unnecessary restrictions to emergency contraception, consistent with the prevailing science and medicine.  As the nation’s leading provider of women’s health care, Planned Parenthood knows firsthand how critical it is that women be able to get emergency contraception quickly and without hurdles.”

MORE: New Availability of Plan B Makes Philadelphia Abortion Doc an Anachronism
Penny Nance, CEO and President of Concerned Women for America (CWA):

“It makes no sense that kids need parental permission to take aspirin at school, but they’re free to buy and administer Plan B. Also known as the morning-after pill, Plan B contains 40 times the dosage of Levonorgestrel, the same drug used in other forms of birth control. If Plan B is so ‘safe,’ then why is a prescription required for birth control? The same ‘women’s rights’ advocates who want every decision to be between ‘a woman and her doctor’ are now eliminating the doctor, isolating young girls in situations that need adult guidance. If health officials continue to push women to make ‘Plan B’ their ‘Plan A,’ we have truly put politics and ‘progress’ ahead of the health of women and, now, our kids.”

Marcia D. Greenberger, Co-President of the National Women’s Law Center:

“While an improvement over current policy, today’s announcement is still disappointing because by retaining an age restriction that the FDA had previously determined was unnecessary, women of all ages must surmount barriers to getting the morning-after pill. Because all women will be required to show an ID to establish their age, those without IDs could be denied access. Further, there is no medical justification for young women under the age-cutoff to have to secure a prescription at all. As a court found recently, the Department of Health & Human Services had in an arbitrary way failed to follow FDA’s original determination and the merit of the ruling still stands.”

Jeanne Monahan, President of the March for Life Education and Defense Fund:

“The decision to make Plan B over-the-counter for girls aged 15 and 16 is not in the best interest of young women’s health. The decision will remove medical screening for adolescents who are sexually active and most people will agree that this defies common sense. Additionally, Plan B does nothing to help the spread of STDs, and studies show that it may in fact exacerbate this problem with young people. Young women deserve better.”

Nancy Northup, president and CEO of the Center for Reproductive Rights:

“The FDA is under a federal court order that makes it crystal clear that emergency contraception must be made available over the counter, without restriction to women of all ages by next Monday. Lowering the age restriction to 15 for over-the-counter access to Plan B One-Step may reduce delays for some young women—but it does nothing to address the significant barriers that far too many women of all ages will still find if they arrive at the drugstore without identification or after the pharmacy gates have been closed for the night or weekend. These are daunting and sometimes insurmountable hoops women are forced to jump through in time-sensitive circumstances, and we will continue our battle in court to remove these arbitrary restrictions on emergency contraception for all women.”

Anna Higgins, Family Research Council’s Director of the Center for Human Dignity:

“This decision shows an alarming lack of concern for the safety of young girls, the fundamental rights of parents, and concerns of the medical community. The effects of taking a high dose of a systematically absorbed hormone during puberty are unknown. There have been no studies on the drug’s effect on young girls. OTC sales could encourage repeat use, which is unsafe.

“Over the counter availability of Plan B for teens distances those girls at highest risk for sexual abuse and sexually transmitted infections (STI’s) from the medical supervision they need. If Plan B is available OTC, teens and women will avoid necessary medical screenings during which serious medical problems like [sexually transmitted diseases] would be detected and treated. A 2010 study out of the UK shows that the increased availability of Plan B to teens was followed by a spike in STI rates among that age group.

“Additionally, this decision undermines the right of parents to make important health decisions for their young daughters. Parents have every right to be involved in any health decisions that affect their children. No parent wants his or her daughter exposed to a potentially dangerous medication without their consent. Instead of allowing unfettered access to potentially dangerous drugs to teens, parent-teen communication regarding the medical and moral issues involved with sexual behavior should be encouraged.”

U.S. Senator Patty Murray (Washington):

“This decision is a step in the right direction for increased access to a product that is a safe and effective method of preventing unintended pregnancies. It’s also a decision that moves us closer to these critical availability decisions being based on science, not politics. Plan B is an essential part of a woman’s basic health care and I will continue to push for more information from FDA and HHS on the practical application of this policy while also working to ensure that access is based on science, safety, and efficacy.”

(MORE: U.S. Rejects FDA Advice to Sell Plan B One-Step Over the Counter)

Marjorie Dannenfelser, president of Susan B. Anthony List, A political action committee helping pro-life women gain election to Congress:

“The FDA is recklessly positioning itself as a parent to our children. Fifteen year old girls need the protection that comes with the involvement of real parents and doctors in their lives. Expanded access to potentially dangerous, abortion-inducing drugs does not strengthen children or families. We strongly urge the Obama Administration to stand by its 2011 position that requiring a prescription for these powerful drugs is common sense.”

20 comments
KateBuccella
KateBuccella

Hey conservative states: How about some form of sexual education beyond the abstinence-only? There is a strong correlation between comprehensive sexual education and lower rates of teen pregnancy. Teach kids about birth control , and how  to be responsible about it. Instead of cramming it down our throats that you shouldn't have sex until you're married, discuss the benefits of doing it with someone you truly care about. Having lived in two states with polar-opposite sex ed stances, I genuinely believe that "abstinence only" education does not work. As for Plan B, it should be available to all, but it needs to be worked into the sex ed curriculum as a possibility, not a primary method of birth control. Discuss the possible side effects, and warn that the hormone levels in the pill can possibly affect puberty. Regardless of how hard abstinence is pushed, teens will have sex. Teen pregnancy is dependent on teens having the right information and the ability to use that information.

Sincerely,

A female high school student

NurseBroccoli
NurseBroccoli

Plan-B advocates and critics alike claim to uphold the health of the young female consumer when staking out their political positions, but reporting on this issue repeatedly fails to answer the question: where do health professionals actually stand? Alexandra Sifferlin’s article recent article on emergency contraception in Time’s Health and Family section does just this, directly quoting 8 different advocates and an FDA commissioner as well as referencing both Judge Korman and HHS Secretary Sebelius while giving voice to only one trained medical “expert” Dr. Jim Sears, the host of a medical talk show on TV. Inclusion of one person’s opinion, no matter how trained can never carry the weight of the collective experience and scientific opinion of organizations like the American College of Obstetricians and Gynecologists, Society for Adolescent Medicine, American Academy of Pediatrics, American Medical Association, American Medical Women’s Association, American Nurses Association and World Health Organization who all stand in support of making emergency contraception widely available. Omitting the opinions of the scientific community may make this and other issues seem more controversial and newsworthy, but does a grave disservice to the American people by subjecting their health to political rather than medical opinion.

bojimbo26
bojimbo26

Buy without prescription but WITH ID .

DerekCope
DerekCope

This is an example of how our "politically correct society" is spinning out of control. We are now too politically correct to tell children they are children, and cannot do some things or be exposed to certain realities of life, until they reach a level of maturity, in an effort to protect them from themselves! Read the article on G*ogle news about the parents who gave a 5 year old a 22 rifle as a gift, the child then accidentally shoots and kills his 2 year old sister. In almost every response, people are raging about charging the parents with a crime, and rightfully so. So why can't we charge parents with negligence when it comes to their kids making more kids that are aborted or otherwise? I guess guns kill, pills save? The end result is the same in both scenarios, a child ended the life of another child, that could've been EASILY avoided, and it doesn't take Sherlock Holmes to figure out the responsibility is on the parents shoulders.

DerekCope
DerekCope

Plan B has already become Plan A. Almost all the female servers and bartenders I employ have either used it, or know someone who has. And there prime motivation was anonymity. Not from there parents (most of these women are 18 or over), but from the MEN who created the child with them. Sex in America has become synonymous with "having a good time" or "going out". Getting knocked up and having an abortion is as common and acceptable as getting drunk and having a hangover, for both men and women. Disgusting.

schroeea
schroeea

@DerekCopeWow.  "Getting knocked up and having an abortion is as common and acceptable as getting drunk and having a hangover, for both men and women."  That's not a generalization at all (read: heavy sarcasm).  I must not live in whatever area you live in because I've only met one person who's had an abortion, due to a rape, and only one friend used Plan B, but that's just because the condom her and her husband were using broke and she wanted to be on the safe side. 

Also, you can totally skip the hangover by doing the glass of water between each drink method.  It really works! 

mtngoatjoe
mtngoatjoe

The availability of Plan-B isn't going to change the relationship good parents have with their kids. And the reality is that it isn't going to change the relationship bad parents have with their kids.

I think that any 14 year old (or 12 year old) that needs to buy Plan-B, needs it because Plan-A didn't work out so well. Plan-A could have failed for any number of reasons (bad parents, bad kids, bad decisions, or God forbid, the girl wasn't given a choice). Restricting access doesn't deal with any of the reasons it's needed. Not one!

absurdbuttrue
absurdbuttrue

This is where the "great uniter" has led the US.  His name will live in infamy!

laugh.or.retch
laugh.or.retch

@absurdbuttrueWhat's truly absurd is that the administration opposed this and you are blaming them for it. In effect you're complaining that they were on your side. LOL

Jasper
Jasper

One thing, over which there is no debate, is that the moral status of abortion, including the use of Plan-B, is hot debated. Even if Plan-B were deemed absolutely and completely safe, without any risk whatsoever, it would be consistent with many other laws to limit access to it by minors. Consider some of the things that have age-based restrictions: driving; voting; going to the movies; buying alcohol; buying cigarettes; entering into legal contracts; serving in the armed forces; employment (requiring work permits and limiting working hours); attending school (required attendance); having sex with an older lover.

Some decisions we simply don't let minors make. This should be one of them. To not restrict access to Plan-B is to simply declare that a decision to use it is not a weighty one, but rather insignificant, in complete disregard for the moral beliefs of many Americans.

Finally, note that the argument from the pro-abortion crowd is self-contradictory. On the one hand, they advocate Plan-B availability as important for avoiding unwanted teen pregnancy.  The implication is that if a pregnancy is unwanted, the right and wise choice is to use Plan-B; it ought to be used; its use is important to avoid these pregnancies. On the other hand, they argue that minors can make these decisions on their own, without parental guidance, as if the decision was not an important one.

Dorama1427
Dorama1427

There aren't as many inconsistencies as you say.  There is no age restriction on getting pregnant, nor even having sex, and so contraception is leggaly available to all ages making it so anyone can buy a condom.  This article talks about the classification of Plan B as contraception, and therefore the argument that it should be freely available and has nothing to do with the Pro-Life/Pro-Choice debate.

Secondly, the major motivation behind the pro-choice crowd (I use the names each side chooses for themselves), is that of minimizing the outcomes of real-world situations.  They know that a girl scared about pregnancy is less likely to tell an adult out of fear, and waiting could turn a mistake, or even failure of normal contraception, into a pregnancy.  Having Plan B available isn't trying to minimize the importance of parents or send a message that abortion is a casual thing; it's to try to reduce the number of unwanted pregnancies, period.  The goal is always reducting the number of unwanted pregnancies, and therefore abortions.

Lastly, Plan B is not an abortion.  It prevents pregnancy, it does not terminate it.  And, anyone who uses Plan B does not want to do it a second time because it's unpleasant to use.  So the liklihood of Plan B becomming Plan A for teens is extremely low.

Jasper
Jasper

@Dorama1427 If life begins when sperm meets egg, and if Plan-B causes that life to be aborted, then it is abortion. You may assert that it is not an abortion, but many would argue otherwise. It obviously has everything to do with the debate over abortion.

leprechaunlady
leprechaunlady

@Jasper @Dorama1427 Plan B does not harm any 46 chromosome zygote. It simply prevents contraception, which is why it is only effective for a short period of time (3-5 days) and effectiveness decreases with the amount of time after unprotected sex. If it could cause an abortion, many women would just take an entire pack of birth control instead of paying $500+ dollars for the abortion pill (which is mifepristone). Plan B is also quite expensive for teens, especially younger ones, yet another reason to not use it as primary contraception. 

Dorama1427
Dorama1427 like.author.displayName 1 Like

Plan B prevents sperm from meeting egg.

Dorama1427
Dorama1427

Not a single mention of males in an article about teen pregnancy. Why aren't boys as scrutinized? Where are the arguments to give parents more control of their behavior, or to make them see a doctor and undergo STI screening before becoming sexually active? Where are the calls for a male version of the pill? Most basically, why hasn't anyone mentioned in this article that 15yo boys can now buy Plan B as well? Why do we place the responsibility (and blame) for being safe and preventing pregnancy on girls when we all know it takes both to have a pregnancy scare in the first place?

urbscap
urbscap

As a 21 year old male, I agree with and support the decision to make Plan-B over the counter and available to minors. Six years ago when I was 15, my 15 year old girlfriend and I had an unfortunate incident where the condom broke. As hysteria ensued, I convinced my friend's 18 year old sister to purchase the morning after pill for us. Looking back, I see how young and irresponsible I was, however I know that I'm not alone in this. At that age, many make mistakes. I'm thankful for how fortunate I was to get through my youth without having a child. This kind of birth control should be available to those having sex, even if they are minors. However, as the name states, it should be considered a backup to proper birth control methods. I often think of what my life would be like if I did have a child at 15. I certainly wouldn't be where I am today, finishing up my four year degree and applying to grad schools, as easily. 

felinius
felinius

"The decision to make Plan B over-the-counter for girls aged 15 and 16 is not in the best interest of young women’s health... Young women deserve better."

Yes, young women do deserve better. Young women need more free and low-cost access to centers like Planned Parenthood to be able to get birth control, counseling, and testing. However, the "pro-life"/"anti-choice" movement has forced the closure of many of these low-cost clinics, which is hilarious given the responses to this Plan B "controversy."

tyrone.m.jackson
tyrone.m.jackson

@felinius Ironic isn't it that the States with the lowest "age of consent" tend to be the States that oppose reproductive rights the most? Thank you, American Taliban.