Health Secretary Blocks Proposal to Allow Plan B on Drugstore Shelves

Teva Pharmaceuticals, the manufacturer of Plan B (the “morning after pill”), submitted a request to the FDA to make the pills available over the counter (OTC) without any age restrictions. That would effectively have paved the way for emergency contraceptives to be sold on store shelves, instead of from behind the pharmacy counter. Today, as expected, FDA scientists recommended that Teva Pharmaceuticals’ request be approved. However, Health Secretary Kathleen Sebelius overruled their recommendation and declined to remove the restrictions.

History of Plan B and the FDA

In 2003, the FDA went against a committee recommendation to make the drug available OTC. According to Jessica Valenti, “they were worried about young women getting all slutty”. She also quoted one of the FDA committee members who said: “What we heard today was frequently about individuals who did not want to take responsibility for their actions and wanted a medication to relieve those consequences.”

Eventually, in 2006, the FDA agreed to make Plan B available without a prescription, but age restrictions on access to it (only for those 17 or over) effectively meant that women had to talk to a pharmacist to get it and that those under 17 had to see a doctor to get a prescription first.

Today’s Overruled Recommendation

This year, Teva Pharmaceuticals applied to have the age restrictions removed, which would have allowed Plan B to be sold on drugstore shelves, right between the condoms and the pregnancy tests. Today, FDA Commissioner Margaret Hamburg, M.D. released a statement noting that teenage girls were able to use Plan B effectively without help. She wrote:

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.

In conclusion, she said:

There is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.

However, Dr. Hamburg then noted that she received a memorandum from Secretary Sebelius indicating that she did not agree with the Agency’s decision and that she was invoking her authority to block the approval.

The Arguments For and Against  Making Plan B More Accessible

As with any issue relating to birth control and reproductive rights, there are countless arguments both for and against it. According to Valenti, the key arguments made by conservatives who oppose OTC sales of Plan B include:

  • It kills babies
  • It will make girls more promiscuous
  • It will make girls more vulnerable to predators
  • It will prevent parents from knowing what their kids are up to

Valenti breaks down each of those arguments, explaining why they are wrong and then goes on to explain the reasons why making Plan B available OTC would be “an important milestone in reproductive health access”:

  • It would remove the age restriction that currently makes Plan B inaccessible to those who need it most.
  • It would cut out the pharmacist middleman, who may judge women and girls asking for it and attempt to insert themselves in their decisions.
  • It has been proven to be safe method of reducing unwanted pregnancies.

When I was 17, my best friend had recently become sexually active with her boyfriend of over a year. They were using condoms, but one night the condom broke. We worked together at the same summer job and after she got off the bus at work the next morning, she told me what had happened. She ended up having to fake an illness and I had to request permission leave work as well to drive her to the doctor to get a prescription and then to the pharmacy to pick up the Plan B. The whole elaborate scheme could have been prevented if she and her boyfriend had been able to stop quickly at the drug store on the drive back to her place the night before.

That is just one example. I’ve heard of other women requesting Plan B because their husband or boyfriend was abusive and they didn’t want to bring a child into a relationship like that. I’ve heard of women who were raped and didn’t want to have the rapist’s baby. I’ve heard of women who would have a difficult time getting out of school or work to go to a doctor’s appointment, but who could easily stop at a drugstore. These are all women who are potential candidates for later getting an abortion or bringing an unwanted baby into the world. Plan B is an effective way to avoid either of those scenarios.

Essentially, the veiled attempts to “protect” women by restricting access to Plan B is, in reality, a way of controlling them, curtailing their freedom, and inconveniencing them for something that they did with (at best) or was done to them by a man.

The Canadian Experience

Plan B has been available OTC in all Canadian provinces except Quebec since 2008. In theory, that is. In practice, people’s experiences are mixed. In Ottawa and Toronto (both in Ontario), it appears to still be behind the counter, but easily accessible if you ask a pharmacist. However, out West it can be purchased openly on store shelves. Some people, both in Ontario and out West reported seeing empty Plan B boxes on the shelf that read “talk to the pharmacist”. In Quebec, where there are still restrictions, Plan B can be obtained by speaking with the pharmacist (no prescription is required). It seems that even with the removal of restrictions in Canada, it may be up to the owners of each pharmacy to decide how they want to handle the sale of Plan B.

The Result: No Change

As a result of Secretary Sebelius’ decision to overrule Dr. Hamburg and the FDA scientists, the current rules regarding access to Plan B will remain in place. All women will be able to access Plan B, but it will remain behind the counter and females under the age of 17 will still need a prescription. Planned Parenthood reacted to the decision by saying that “The FDA’s decision today will no doubt prevent thousands of women and teens from being able to prevent unintended pregnancies.”

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Photo credit: meddygarnet on flickr

55 comments

Holly Marback
Holly M.4 years ago

Worried about girls "getting all slutty?" That has happened for centuries (along with horny boys), long before Plan B. In my area, Plan B costs around $80, so it's probably not going to be anyone's first contraceptive choice, because there are other less expensive things. At that price, it's not likely that anyone's going to buy enough Plan B for a party or a whole neighborhood---both of which I heard as reasons not to offer it when there was debate in my area. Let people buy it OTC. Those who don't want it can choose not to. When my daughter was younger, I always said I'd buy it for her if need be.

Ann Will
Ann Cannoy4 years ago

If the people that dont want the morning after pill to be sold over the counter because of some stupid right to mlife opinion then they need to get educated.

This pill works by not allowing this 24 year old cell from implanting itself to the uterus. therefore no pregnancy exists and no child exists either.

I wish these bigots would try and get some scientific information.

Carole R.
Carole R.4 years ago

Every woman should have access to any form of birth control she perfers. It is a very personal decision that should not be under government control.

Ellie Damann
.4 years ago

keep abortion and birth control legal

K s Goh
KS Goh4 years ago

Thanks for the article.

Rebecca S.
Rebecca S.4 years ago

girls and women need easy access to the drug, but it should remain behind counters so that pharmacists can educate them on it before giving it to them. Plus you don't want overuse of the drug.

Tracy S.
Tracy S.4 years ago

What I mean is, what is wrong with this not being on the shelves of every drug store? Children do not read, they only react.

Tracy S.
Tracy S.4 years ago

If kids cant talk to their parents and need to go to planned parenthood or some other agency to get informed before taking something that could harm them (there is talk that the "plan B" pill could be dangerous to people underage) what is wrong with that? If a 10 year old is having sex, there is something very wrong. And a 10 year old is not going to read everything on the box having to do with complications and what to do about them. Who will be yelling then, when we hear of underage kids dying or having some other serious complications from this?

BMutiny TCorporationsEvil

I don't think many 10- or 11-year-olds would have the MONEY to voluntarily go and purchase "Plan B" -- you are making this "sensational" claim just as a "worst-case-scenario".
If a 10-or-11-year-old girl is having sex, she is being RAPED, most likely by an adult in the FAMILY or close to the family. She is legally INCAPABLE of giving "consent". If such a mythical 10-year-old asked for a "Plan B" pill for herself, the adult to whom she made the request would be LEGALLY REQUIRED TO REPORT CHILD ABUSE. {Therefore the person who raped her would be likely to discourage such a request being made! by every means in his power.}

However, many 16- and 15- year-olds ARE voluntarily having sex; and many of them, it is impossible to tell from looking at them, how old they are.
Altho, depending on the Age of Consent where they live, this may legally constitute Statutory Rape, the issue is not quite as clear-cut.
It would be FAR BETTER for a teenager, even if she has been raped, ESPECIALLY if she has been raped, or if she has had consensual sex, to NOT be forced to deal with having an unplanned-for baby. That keeps the other issues, rape or statutory rape, etc., as SEPARATE issues to be dealt with.
It is the compassionate thing, to not force an unwanted pregnancy, abortion or child on a teenager of ANY age.
What about one who is raped by her FATHER, or other family member? or by her Priest, Coach, Minister, Youth Counselor, etc.? should she have to ask THEM for "consent" to get Plan

Sue Matheson
Sue Matheson4 years ago

thanks.