FDA Eases Limits on Plan B Sales (Morning After Pill)

[ruggerson]

http://apnews.myway.com/article/20060824/D8JMQCPO0.html

Aug 24, 9:15 AM (ET)

By ANDREW BRIDGES

WASHINGTON (AP) - Women may buy the morning-after pill without a prescription - but only with proof they're 18 or older, federal health officials ruled Thursday, capping a contentious 3-year effort to ease access to the emergency contraceptive.

Girls 17 and younger still will need a doctor's note to buy the pills, called Plan B, the Food and Drug Administration told manufacturer Barr Pharmaceuticals Inc. (BRL)

The compromise decision is a partial victory for women's advocacy and medical groups that say eliminating sales restrictions could cut in half the nation's 3 million annual unplanned pregnancies.

The pills are a concentrated dose of the same drug found in many regular birth-control pills. When a woman takes the pills within 72 hours of unprotected sex, they can lower the risk of pregnancy by up to 89 percent. If she already is pregnant, the pills have no effect.

(more)

[whistle]

1. I was wondering how this pill works and found this article from the UK

...where the treatment has been in use for some time now.

<snip>
The morning-after pill
Written by Dr David Delvin, GP and family planning specialist

What is the morning-after pill?
The morning-after Pill needs to be taken within 72 hours after unprotected sex.

Although lots of people talk about ‘the morning-after pill’ this term is actually very misleading.

Why? Because in fact, you don’t have to take this pill on ‘the morning after’ having sex. In reality, it is fairly effective for up to 72 hours (three days).

However, the earlier you take it the better; it works best if taken within 24 hours of unprotected sex.
<more>
http://www.netdoctor.co.uk/sex_relationships/facts/morningafterpill.htm

[Mountainman]

2. So a girl under 18 has sex, then must make a doctor's appointment

which may take days or weeks then get a note then go to the pharmacy? She's pregnant by then.

[hippiechick]

8. Well, one would hope she's in communication with her mom ...

... I know I'd be more than willing to make sure that there was at least one dose on hand in the Hippie Household and that Hippie Kid and I had discussed the implications both of being frisky at a young age, and needing to use Plan B long before the 'emergency' occurs.

[OldSiouxWarrior]

9. Or she simply gets an over-18 friend to buy them.

In reality, that will be a rather minor impediment.

[BlameAmericaFirst]

11. A cheap, free alternative is available....

sorry this was tasteless, insensitive and not funny

[MaineDem]

12. Huh??? n/t

[MaineDem]

13. Wasn't sure just what you meant

I think you made a typo which confused me. If I understand what you intended to type, you're right, very tasteless and insensitive. Thank you for realizing that on your own.

Welcome to DU.

[Nickster]

3. Do girls under 18 have to have a doctor's note to get birth control now?

[whistle]

4. Remember, the article I posted pertains to the UK....I would think

...though that these same tactics will be used here in the U.S. unless all barriers are torn down quickly against this sort of thing. The biggest barrier will be ignorance. This pill is not, repeat NOT an abortion pill! It is another form of birth-control pill from my reading of it.

[Nickster]

6. I was coming from the birth control pill angle. My first thought was, why

should the plan-b pill be treated any differently from regular birth control pills when they are essentially the same thing, but I don't know what the regulation is currently for teenage girls and birth control pills.

[depakid]

15. Because it's time sensitive

and proven through years of research to be much safer than most medications that are available over the counter.

The faster it's used- the more effective it is. (you'd think people who oppose abortion would be pleased about preventing them, but in their whack logic- which ignores the science, Plan B is akin to RU 486).

Another thing to consider is that it's not cheap- prices average around $35 - $40.

[Nickster]

16. Still not getting an answer to my question.

Is birth control a prescription drug? Do girls under the age of 18 currently require a prescription from a doctor to get birth control pills currently? I don't know, that's why I ask. I have no frame of reference for that kind of thing.

If birth control is an Rx and plan b isn't, then why isn't the birth control pill being made into an OTC drug as well? Or why aren't they both Rx? They are essentially the same thing no?

How many other OTC drugs require a Dr's note? How can this be made an OTC, yet still require a Rx? Thin line between a Dr note and an Rx don't you think?

Claritan is expensive too, a dollar a pill on average, so 30 bucks a month.

[depakid]

17. The main issue is safety and effectiveness

the same active ingredient can be marketed both Rx and OTC depending on its usage- provided that scientific studies demonstrate Rx dispensing is:

...not necessary for the protection of the public health by reason of the drug's toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, and . . . the drug is safe and effective for use in self-medication as directed in proposed labeling.

21 C.F.R. § 310.200(b).

That's the standard.

Plan B more than meets that standard.

On the other hand, as a long term and ongoing health concern- women vary considerably in their responses to different forms of "the pill." There may be side effects involved- or drug interctions and a host of other issues that need to be addressed by qualified physicians.

Hence the requirement for a prescription.

[jayctravis]

18. Yes, in the USA birth control pills are prescription only.

[swag]

5. Here's the message from NARAL

We did it!
At 9:20 a.m. today, the FDA approved over-the-counter access to the "morning-after" pill!

Dear Pro-Choice Activist,

Thanks to the letters, petitions, and support from people like you, the FDA finally overcame the political pressure from the White House, Congress, and anti-choice lobbyists, and approved the morning-after pill for over-the-counter sales.

Medical experts and scientists at the FDA have asserted for years that the morning-after pill - which can prevent an unintended pregnancy if taken within 72 hours after sex - should be available without a prescription. It's safe, it's effective, and it's a commonsense way for women to prevent unintended pregnancy.

Thank you again for helping achieve this victory for women - your action does make a difference.

[MaineDem]

10. And from Planned Parenthood...

Plan B prevails! Today, after years of foot-dragging, the FDA put politics aside and granted over-the-counter status to emergency contraception for women 18 and older.

This victory is the result of years of pressure from the scientific and medical communities and pro-choice activists, including thousands of Planned Parenthood supporters like YOU. Thank you!

Please take a moment to thank Sens. Hillary Clinton (D-NY) and Patty Murray (D-WA), for their indispensable leadership on this issue.

While emergency contraception is not yet available over-the-counter — you can always get emergency contraception at your local Planned Parenthood. Celebrate this momentous decision today by picking up a package of emergency contraception to back up your birth control!

This is a huge, long-awaited success — but there is still more work to be done. In its announcement, the FDA stated it will not approve over-the-counter sales of Plan B to women under 18. It continues to deny teens the benefits of greater access to emergency contraception.

Our country has a serious teen pregnancy problem. As we all know, anything that makes it harder for teens to prevent unintended pregnancy is bad medicine and bad policy.

What's more, this age restriction means pharmacies will likely keep this safe, effective backup method of birth control behind the counter, forcing all women to ask a pharmacist's permission to access it.

We will continue to work diligently to secure over-the-counter access of emergency contraception for ALL women of ALL ages — without them needing permission from a pharmacist.

Thank you for your help in getting us this far!

Sincerely,

Cecile Richards
President
Planned Parenthood Federation of America

P.S. Here's how we got to where we are today (it's been a long road to victory!):

December 16, 2003: A joint hearing of the FDA Nonprescription Drugs and Reproductive Health Drugs Advisory Committees votes 23 to four to recommend that the FDA make Plan B emergency contraception available over the counter.

May 6, 2004: The FDA notifies Barr Laboratories, which manufactures Plan B, that its application for over-the-counter status is denied, citing concerns about adolescent use.

January 21, 2005: In a highly unusual move, the FDA misses its deadline to rule on the revised application. The agency indicates that review of the medication is expected to be completed in the near future but does not specify a date.

July 15, 2005: Sens. Hillary Clinton (D-NY) and Patty Murray (D-WA) obtain agreement from the FDA to rule on Plan B status by September 1, 2005.

August 26, 2005: The FDA announces yet another delay on issuing a decision on the application to make Plan B available over the counter.

July 31, 2006: The FDA announces it will open discussions with Barr Laboratories to make Plan B available over the counter for women 18 and over. The FDA states it will not approve Plan B for over-the-counter sale to young women under 18.

August 24, 2006: The FDA approves over-the-counter sale of Plan B to women 18 and over.

[madrchsod]

7. the moral fasists won`t be happy about this....

the under 18 is a joke...they`ll have their friends or mom buy it. they also can order the stuff over the internet for the "just in case".

[Seedersandleechers]

14. Reproductive clinics have been using this for over thirty years

Edited by myself. I didn't know if there was a rule against giving out sample dose info...

[CornField]

19. Please note: these are most effective during the first 24 hours

While these can work up to 72 hours after the fact, they are the most effective within 24 hours.

[VegasWolf]

20. The brain-dead, "Get 'er done!", redneck FReeks are screaming in pain

over this one.

[Marie26]

21. Finally

There was absolutely no reason why this drug should be restricted, beyond the paranoid hysteria of the fundies. I'm glad reason prevailed, in this case at least.