FDA Makes Plan B Available Over The Counter To 15 Year Olds

The FDA has modified it's rules on the availability of a politically controversial form of birth control.

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Earlier this month, a Federal District Court Judge in New York struck down a rule promulgated by the Food And Drug Administration that stated that “Plan B” and similar “morning after” pills would only be available to girls under seventeen years of age.  Today, in what seems like a partial response to that ruling, the FDA has revised its rule so that the drugs will now be available over the counter to girls as young as 15:

The U.S. Food and Drug Administration announced Tuesday that it approved the availability of the Plan B One-Step emergency contraception pill without a prescription for women 15 and older.

This move comes just weeks after a federal judge in Brooklyn, New York, ordered the FDA to make the morning-after birth control pill available to women of any age, without a prescription. Tuesday’s FDA announcement, which pertains to an application from Teva Women’s Health, Inc., is not related to that, the FDA said.

“The FDA’s approval of Teva’s current application for Plan B One-Step is independent of that litigation and this decision is not intended to address the judge’s ruling,” the FDA said in a statement.

In early April, the U.S. Justice Department indicated an appeal of the Brooklyn judge’s order was under consideration. “The Department of Justice is reviewing the appellate options and expects to act promptly,” department spokeswoman Allison Price said.

According to the new FDA decision, Plan B One-Step will now be labeled to reflect that proof of age is required to purchase it, and it cannot be sold where age cannot be verified. The packaging will include a product code that prompts the cashier to ask and verify the age of the customer.

The product will be available in retail outlets with pharmacies, but the pill can be sold during non-pharmacy hours, too.

“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,” Planned Parenthood Federation of America President Cecile Richards said Tuesday in a statement.

The FDA decision does not pertain to the two other emergency contraceptive drugs marketed in the United States. Plan B is available from generic manufacturers over-the-counter for women 17 and older and Ella is available by prescription only, for all ages, and prevents pregnancy within five days of unprotected sex or contraceptive failure.

“Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States,” said FDA Commissioner Dr. Margaret A. Hamburg in a statement. “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.”

The Washington Post’s Sarah Kliff comments:

This is not, as the FDA points out in a statement, a response to the recent court decision on emergency contraceptives. In that April 5 case, a federal judge ordered the Obama administration to make Plan B available over the counter to women of all ages — not just those who are 15 and older.

“The Department of Justice is considering next steps in the litigation,” FDA officials said in a statement. “In the meantime, the FDA took independent action to approve the pending application on Plan B One-Step for use without a prescription by women 15 years of age or older.”

We don’t know yet whether the Department of Justice will file an appeal to the court decision, but we will know soon: The Obama administration only has until May 5 to do so.

If the federal government does not appeal and does comply with the federal court ruling, it would make this FDA rule, in a way, moot. Under that scenario, the FDA would agree to allow emergency contraceptives to be sold without any age verification.

If Justice goes the other route, and appeals the court decision, then this policy would have a lot more meaning. It would liberalize access to emergency contraceptives for women of all ages by making Plan B One-Step available in situations when a drug store may be open — but it’s pharmacy is closed.

Jon Terbush, though, points out that the new FDA rule isn’t likely to please anyone:

For one, it falls short of the unrestricted access favored by leading science and health groups like the American Medical Association. They’re joined by liberal lawmakers, including Sen. Patty Murray (D-Wash.), who called the change a “step in the right direction,” but said she would keep pushing for more open access. Planned Parenthood vowed to do the same, as did the Center for Reproductive Rights, which filed the lawsuit that led to the recent court ruling.

“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,” Nancy Northup, president and CEO of the Center for Reproductive Rights, said in a statement.

Social conservatives, meanwhile, are miffed that the FDA has granted wider access to a pill they oppose on principle.

“This ruling places the health of young girls at risk,” a spokesperson for the Family Research Council told Life News. “Making Plan B available for girls under the age of 17 without a prescription flies in the face of medical information and sound judgment.”

Kate Sheppard also points out another part of the new rule that is likely to displease advocates of wider availability of morning after pills. Specifically, because there’s an age restriction on availability without a prescription, the rule requires pharmacies to check identification to verify that the person making the purchase is over the age of fifteen. Obviously, most girls who are fifteen, or even sixteen, are not going to have a driver’s license and would not typically carry around some other form of government identification. One also presumes that the identification cards that many High Schools now issue to students is not going to be considered sufficient unless it includes a date of birth. This requirement also conflicts with the Court Order issued last month which requires the FDA to make Plan B available over the counter to women of all ages. That order goes into effect on May 5th unless the Justice Department decides to appeal the case and obtains a stay of the ruling. So far, there’s been no word from the DoJ in that regard, although it strikes me that they are more likely than not to appeal the decision at least to the Circuit Court level.

Politically, of course, this is as likely to set off a political firestorm as the court decision last month did. Scientifically, it appears to be the case that there is no valid reason for the FDA to place an age restriction on the use of Plan B, which is why the Judge ruled the way that he did. Given that, restrictions based on age would seem to be outside the bounds of FDA rulemaking. At the same time, though, it’s quite obvious that the idea of making a drug like this available to teenage girls without a prescription and, presumably, without parental knowledge and consent is something that’s likely to make a substantial group of people, including people who might not necessarily qualify as hard-core social conservatives, uncomfortable to say the least. As I when discussing this last month, it is entirely possible for Congress to take control of this issue by passing a law directing the FDA to require a prescription for minors who want this medication, although that’s unlikely to happen in the current political climate. Nonetheless, I think we an expect to see candidates forced to take a position on this issue.

FILED UNDER: Health, Health Care, Law and the Courts, US Politics
Doug Mataconis
About Doug Mataconis
Doug holds a B.A. in Political Science from Rutgers University and J.D. from George Mason University School of Law. He joined the staff of OTB in May 2010. Before joining OTB, he wrote at Below The BeltwayThe Liberty Papers, and United Liberty Follow Doug on Twitter | Facebook

Comments

  1. Jenos Idanian #13 says:

    Pedophiles, rejoice!

    “Excuse me, I’d like some Plan B.”

    “No problem, little lady. Here you go. Anything else?”

    “Yes, a box of Sudafed.”

    “I’ll need to see your ID.”

    “I’m only 13, I don’t have an ID.”

    “Sorry, can’t sell you that. Will that be cash or charge for the Plan B?”

  2. michael reynolds says:

    @Jenos Idanian #13:
    You know what else is available at drugstores? Douches. But then you know that.

  3. grumpy realist says:

    Jenos, please look up the definition of pedophile. Now please look up the definition for statutory rape.

    Please tell me how the availability of Plan B to 15-year olds negates the statutes on the books against pedophilia and statutory rape.

    Take your time….

  4. Neil Hudelson says:

    So in shitforbrains Jenos’s mind, there are hordes of pedophiles kept at bay because of the lack of proper birth control?

  5. anjin-san says:

    No doubt there are a lot of conservatives out there who themselves have the sex life of a lawn gnome that will be outraged by this.

    In the real world, teenagers have sex. Let’s deal with it as best we can.

  6. Jenos Idanian #13 says:

    @grumpy realist: Oh, grumpster. You’re so cute when you’re ingenuous.

    The ready access to Plan B enables pedophiles/statutory rapists by taking away one opportunity for parents to discover their underage daughter is being exploited. It’s another tool in their arsenal — “just take this the next morning, and it’ll be just fine. No one need ever know what we’re doing.”

    But then, parents aren’t to be trusted anyway, right?

  7. Ben says:

    @anjin-san:

    In the real world, teenagers have sex. Let’s deal with it as best we can.

    Exactly. There are thousands and thousands (maybe hundreds of thousands) of teenage girls who have shitty abusive parents, and those parents then abuse the girls, physically or emotionally, when the girl turns up pregnant. This rule will spare a lot more suffering than it will create because of “enabling pedophiles”, Jenos.

  8. OzarkHillbilly says:

    @Jenos Idanian #13:

    Oh, grumpster. You’re so cute when you’re ingenuous.

    Oh Jenos, you are so not cute when you are stupid, you are just another blithering idiot.

    It’s another tool in their arsenal —

    Are you really this stupid? Never mind of course you are, you’re arsenal long ago became an empty tool box. You could argue this from the point of parental rights, where at least you would get a sympathetic ear, but no. Instead you pick some fantasy from your deepest darkest recesses from which to argue.

  9. PJ says:

    @Jenos Idanian #13:

    Pedophiles, rejoice!

    “Excuse me, I’d like some Plan B.”

    “No problem, little lady. Here you go. Anything else?”

    “Yes, a box of Sudafed.”

    “I’ll need to see your ID.”

    “I’m only 13, I don’t have an ID.”

    “Sorry, can’t sell you that. Will that be cash or charge for the Plan B?”

    I must say, you type very well using only one hand.

  10. wr says:

    @Jenos Idanian #13: “The ready access to Plan B enables pedophiles/statutory rapists by taking away one opportunity for parents to discover their underage daughter is being exploited.”

    Yes, we can all agree that it is the duty of every teenage girl who is having sex to get pregnant to give her parents a chance to weigh in on the subject.

    Oh, and she must also carry the pregnancy to term, because what happens inside her body is solely the concern of Jenos Tea.

  11. Crusty Dem says:

    @Jenos Idanian #13:

    In your world, making Plan B slightly more available to teenagers allows pedophiles to run rampant. And yet, anything which hinders crazy/violent people from getting their hands on guns is a useless waste of time.

    Your world is a strange place so full of inconsistencies and mysteries, I’m not sure a logical mind could survive..

  12. Gromitt Gunn says:

    @Jenos Idanian #13: What’s it like to live in a world where all parents are responsible caring compassionate adults who listen to and are actively involved in the lives of their teenagers? I live in a world where parents don’t always think about the safety of their children when they let a boyfriend or girlfriend move in, where the adults in the household are frequently the abusers and the rapists or their enablers, where teenagers are sex workers, and where around 40% of homeless teens are LGBT because their home lives became untenable.

    Yours sounds so much nicer. What is your planet called?

  13. Jack says:

    ID (proof of age) is required for Plan B to prove you are 15 years or older, yet there is still no ID requirement to vote. Where are all the liberals complaining about how this ID requirement is going to hurt minorities?

  14. Tyrell says:

    There absolutely needs to be a required parental consent to receive these . Around here a parent must sign for a child to get a library card, team sports participation, field trips, and to ride home from school with a friend. Another step in the government taking over parental authority and rights. State governments need to step in and require parental permission.
    Parents: wake up and stand up!

  15. grumpy realist says:

    @Tyrell: The same parental consent of the father who is raping his daughter?

  16. Rafer Janders says:

    @Tyrell:

    By the time a girl needs Plan B, SHE’S ALREADY HAD SEX. What about this don’t you understand?

  17. Rafer Janders says:

    @Tyrell:

    Another step in the government taking over parental authority and rights.

    This is step one. By the time we get to step ten, we’ll be raising your children in collective education pods in the FEMA camps.

  18. martin says:

    OK
    1 WHY ARE 15 YEAR OLDS HAVING SEX

  19. wr says:

    @martin: “1 WHY ARE 15 YEAR OLDS HAVING SEX”

    Unless you are one of the 15 year olds, or the parent of one of the 15 year olds, that’s really none of your business. Even if you are a Republican.

  20. wr says:

    @Gromitt Gunn: “What is your planet called? ”

    Mommy’s house.

  21. Ben Wolf says:

    New Zealand has a wonderful law whereby girls in primary or secondary school can request of their school nurse to be taken to a family planning clinic in the event of pregnancy. Without parental notification. It’s been a useful tool for exposing pedophilia and incestuous rape of children. Why? Because the pedophiles and parents are usually one and the same. Does anyone think a man who just raped his daughter is going to give permission for examination and implicate himself?

  22. Caj says:

    Many young teenage girls are having sex anyway whether they parents like to believe it or not. Some who think their daughters are as white as the driven snow are living in cloud cuckoo land. Birth control is much better than having to make the awful decision to have an abortion. Children don’t asked to be born, so prevention is by far the better choice. The Catholic Church and other religious groups can’t have it both ways though. No contraception. No abortion. That’s not real life today and it’s about time they moved into the 21st century.

  23. mantis says:

    @martin:

    1 WHY ARE 15 YEAR OLDS HAVING SEX

    Because they can, just like in…oh, all of human history.

  24. legion says:

    @Jenos Idanian #13: Jesus F*cking Christ. There’s trolling, and then there’s being positively subhuman. You really get your jollies by making a joke out of child rape and seeing how you can get us to dance in outrage. I take pride in my vocabulary, both high brow and low, but I just don’t have words for how vile you are.