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Health Secretary Blocks Proposal to Allow Plan B on Drugstore Shelves

Health Secretary Blocks Proposal to Allow Plan B on Drugstore Shelves
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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.

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55 comments

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7:32PM PDT on Jun 30, 2012

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.

2:20PM PST on Feb 8, 2012

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.

1:02PM PST on Jan 3, 2012

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.

9:12AM PST on Dec 14, 2011

keep abortion and birth control legal

4:28AM PST on Dec 12, 2011

Thanks for the article.

10:21PM PST on Dec 9, 2011

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.

2:25PM PST on Dec 9, 2011

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.

2:24PM PST on Dec 9, 2011

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?

1:26PM PST on Dec 9, 2011

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

11:25AM PST on Dec 9, 2011

thanks.

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