FDA approves morning after pill for over the counter!

irishgrl · #1 08-24-2006, 01:54 PM

FDA OKs wider access for Plan B pill By Lisa Richwine
Thu Aug 24, 10:30 AM ET

Adult women can buy a "morning-after" contraceptive without a prescription, U.S. health officials said on Thursday after a three-year political battle over wider access.

Barr Pharmaceuticals Inc.'s (NYSE:BRL - news) Plan B must stay behind pharmacy counters, the Food and Drug Administration said. Women must show proof they are at least 18 to buy the emergency contraceptive pills without a prescription, and younger girls still need a doctor's order.

"When used as directed, Plan B effectively and safely prevents pregnancy," the FDA said in a statement.

Backers and opponents had fiercely lobbied the agency with arguments about Plan B's impact on abortion rates and teen sex, and the feud stalled the nominations of two FDA commissioners.

Two Plan B pills can prevent pregnancy when taken within 72 hours of sexual intercourse.

Women's groups and other supporters argued easier access would reduce the number of unwanted pregnancies and abortions. Conservative opponents said wider availability would lead to more teen-age promiscuity and sexually transmitted diseases.

Barr agreed to monitor enforcement of the age limit and to limit Plan B's distribution to health clinics and stores with pharmacies, the FDA said. The pills should be available in dual nonprescription and prescription packages by the end of the year. Prescription packages are available now.

"While we still feel that Plan B should be available to a broader age group without a prescription, we are pleased that the agency has determined that Plan B is safe and effective for use by those 18 years of age and older as an over-the-counter product," Barr Chief Executive Bruce Downey said in a statement.

The company originally had sought permission to sell Plan B over the counter without age limits.

Throughout the process, two Democratic senators blocked votes on President George W. Bush's nominees to run the FDA.

After the FDA decision, Sens. Patty Murray of Washington and Hillary Rodham Clinton of New York dropped their objections to a Senate vote on the confirmation of Bush's current pick, acting FDA Commissioner Andrew von Eschenbach, a Murray spokeswoman said.

Since Barr's initial bid in April 2003 to allow sales of the contraceptive without a prescription, repeated delays sparked charges that the FDA let politics override science.

In December 2003, a panel of outside advisers voted 23-4 to recommend switching Plan B from a prescription to over-the-counter drug. FDA staff scientists agreed, but a senior official rejected approval over concerns that young girls might not be able to use the pills safely.

Barr submitted a new bid for over-the-counter sales to females 16 and older. The FDA deferred a decision on that plan and last month proposed the 18-and-older scenario.

Plan B pills contain higher doses of progestin, a hormone used in prescription birth-control pills. Women are supposed to take two tablets 12 hours apart.

The pills block the release or fertilization of an egg. Some research suggests Plan B also may keep a fertilized egg from attaching to the womb, and some opponents considered that mechanism equal to an abortion.

Plan B is different from RU-486, a pill that causes an abortion early in pregnancy by blocking the hormone that keeps a fertilized egg implanted in the uterus. RU-486 also is known as Mifeprex or mifepristone.

Shares of Barr, which is based in Woodcliff Lake, New Jersey, rose $1.03, or 1.8 percent, to $59 in morning New York Stock Exchange trade.

(Additional reporting by Susan Heavey)

amber · #2 08-24-2006, 02:04 PM

Well, Hallelujah! The Christian right is strong, but the pharmaceutical lobby is stronger. Which is favorable in this instance.

That is pretty convenient.

hayley · #3 08-24-2006, 02:23 PM

Oh, good. I ****ed like ten guys the other night at the Def Leppard/Journey concert out on the lawn, and I'd left the condoms out in the truck. Then again, I only had eight of them so I guess it wouldn't have mattered anyways.

I was gonna douche with coca-cola, I read in one of those awesome emails that I get forwarded that it works like a charm. But now this makes it way easier for next time.

strandinthewind · #4 08-24-2006, 02:27 PM

Quote:

Originally Posted by hayley

Oh, good. I ****ed like ten guys the other night at the Def Leppard/Journey concert out on the lawn, . . . .

That was you

I had a great time

hayley · #5 08-24-2006, 02:32 PM

Quote:

Originally Posted by strandinthewind

That was you

I had a great time

Which one were you? If you were the one with the Billy Squier t-shirt who kept repeating lines from "The Stroke" while we were rolling around, there is no way I'm calling YOU back.

strandinthewind · #6 08-24-2006, 02:35 PM

Quote:

Originally Posted by hayley

Which one were you? If you were the one with the Billy Squier t-shirt who kept repeating lines from "The Stroke" while we were rolling around, there is no way I'm calling YOU back.

Well, there was no way you were gonna simmer down

carrie721 · #7 08-24-2006, 02:45 PM

this is good news!

estranged4life · #8 08-24-2006, 02:48 PM

Quote:

Originally Posted by hayley

Oh, good. I ****ed like ten guys the other night at the Def Leppard/Journey concert out on the lawn, and I'd left the condoms out in the truck. Then again, I only had eight of them so I guess it wouldn't have mattered anyways.

I was gonna douche with coca-cola, I read in one of those awesome emails that I get forwarded that it works like a charm. But now this makes it way easier for next time.

couldnt recognize ya from the back

amber · #9 08-24-2006, 02:51 PM

Quote:

Originally Posted by carrie721

this is good news!

I agree, but...um...you won't really ever need this.

I think it's funny that people presume that it would only be needed in the event that someone was promiscuous or stupid. I mean, I'm sure married people who don't want kids right now, and people who just sleep with one person, and all kinds of non slutty people use it. Not that I approve of the term "slut" to describe anyone, what people do is their own business, and who they sleep with doesn't affect me. And god bless anyone who chooses not to have a child when they shouldn't, or don't want to. Any population growth reduction is A-okay in my book.

carrie721 · #10 08-24-2006, 02:56 PM

Quote:

Originally Posted by amber

I agree, but...um...you won't really ever need this.

I think it's funny that people presume that it would only be needed in the event that someone was promiscuous or stupid. I mean, I'm sure married people who don't want kids right now, and people who just sleep with one person, and all kinds of non slutty people use it. Not that I approve of the term "slut" to describe anyone, what people do is their own business, and who they sleep with doesn't affect me. And god bless anyone who chooses not to have a child when they shouldn't, or don't want to. Any population growth reduction is A-okay in my book.

hee. yeah, you're right about that. but y'know ... i could get really drunk one night and ...

ok, still probably not.

i agree. i'm sure there is a huge non-"slut" market out there for this drug.

irishgrl · #11 08-24-2006, 03:14 PM

I dont know about any of youse guys, but I was very surprised this passed! Bushwhacker has filled all the key positions with anti-choice people so there musta been some MAJOR pull from the more liberal sector somehow...

'course, I know the pill companies like this idea but they arent going to be selling all THAT many pills compared to heartburn medicine or depression medicine or something like that...this isnt going to be a real huge money maker for them so Im just surprised all around that it passed. Anyway, its a HUGE victory for women's rights issues (autonomy and all that) so, that MY big thing.

DavidMn · #12 08-24-2006, 03:32 PM

Quote:

Originally Posted by hayley

Oh, good. I ****ed like ten guys the other night at the Def Leppard/Journey concert out on the lawn, and I'd left the condoms out in the truck. Then again, I only had eight of them so I guess it wouldn't have mattered anyways.

I was gonna douche with coca-cola, I read in one of those awesome emails that I get forwarded that it works like a charm. But now this makes it way easier for next time.

I swear that threw me right to the floor!!!

mikeschmike · #13 08-24-2006, 03:34 PM

Quote:

Originally Posted by hayley

I was gonna douche with coca-cola, I read in one of those awesome emails that I get forwarded that it works like a charm. But now this makes it way easier for next time.

Just stay away from Mentos. your junk will explode!

DavidMn · #14 08-24-2006, 03:38 PM

Quote:

Originally Posted by mikeschmike

Just stay away from Mentos. your junk will explode!

INteresting visual there....

skcin · #15 08-24-2006, 03:39 PM

Great news for our clinic. I can't tell you how much time we waste on people wanting the MAP, when other (sick, injured) kids could be seen instead in that appointment slot.

In general, most people use it once in a while, they usually say the condom breaks. I must say, I've never had a condom break during sex, so they must be doing something wrong with it if it happens often.

A few women come in pretty frequently, which is probably not the best thing. But in reality, studies have not shown any physical complications from using it too often. I personally wouldn't want to keep ingesting large amounts of hormones, but hey - it's their body.