Proposal would allow Plan B sale to women over 18 without prescription

[AliceInWonderland]

FDA reverses course on morning-after pill
Proposal would allow Plan B sale to women over 18 without prescription

WASHINGTON (AP) -- The government revived efforts Monday to widen access to the morning-after pill, but only to women 18 and older, issuing a surprise announcement that it was reconsidering over-the-counter sale of the emergency contraceptive almost a year after it was thought doomed.

The Food and Drug Administration notified manufacturer Barr Pharmaceuticals Inc. early Monday that it wanted to meet within seven days to iron out new steps the company must take in its three-year battle to sell the pill, called Plan B, without a prescription to at least some women.

"We think this is a positive development. We will see how the meeting goes and move forward from there," company spokeswoman Carol Cox said.

Cox could not predict how quickly the company could amend its FDA application, which already includes a plan to restrict distribution of the pills. The FDA said a final decision could be reached within weeks, if talks with Barr go well.

The announcement came just 24 hours before President Bush's nominee to lead the regulatory agency, Dr. Andrew von Eschenbach, was scheduled to appear before a Senate committee, where he was expected to face grilling on why the morning-after pill had apparently gone into bureaucratic limbo.

Meanwhile, two senators who have held up the nomination said Monday they would continue to do so until the agency makes a decision on the morning-after pill.

The morning-after pill is a high dose of regular birth control that, taken within 72 hours of unprotected sex, can lower the risk of pregnancy by up to 89 percent.

Contraceptive advocates and doctors groups say easier access to a pill now available by prescription only could halve the nation's 3 million annual unintended pregnancies, and FDA's own scientists say the pills are safe. In December 2003, the agency's independent scientific advisers overwhelmingly backed nonprescription sales for all ages.

But the FDA rejected that recommendation, citing concern about young teens' use of the pills without a doctor's guidance. Barr reapplied, asking that women 16 and older be allowed to buy Plan B without a prescription and setting up a program for pharmacists to enforce the age rule -- just as they now enforce age restrictions on cigarette sales.

But last August, FDA's then-chief postponed a decision indefinitely, saying the agency needed to determine how to enforce those age restrictions -- something that it said would require the formality of writing new regulations.

Monday, the FDA reversed itself, saying that it had reviewed about 47,000 comments from the public, with an overwhelming majority supporting the view that the drug could be sold both as a prescription and nonprescription product.

"It is not necessary to engage in rulemaking," von Eschenbach wrote the company Monday.

To try again, Barr must re-file its application with some changes:

•Barr must agree to sell nonprescription to women 18 and older, not 16 as the company had earlier sought. That's because it conforms with current age restrictions on tobacco products, and thus would simplify pharmacists' enforcement.

•Both the nonprescription and prescription versions of the pill would be kept behind the pharmacists' counter. But FDA wants Barr to sell the nonpresription version in completely different packaging to help distinguish the two.

•Barr must provide details on how the program will enforce the age restriction. If that's not rigorous enough, Plan B will remain prescription for everyone, FDA warned.

"We already said that we would only sell to pharmacies -- to places where there was a pharmacist, not to convenience stores," Cox said.

Asked why the FDA was moving forward now, 11 months after delaying a decision, FDA spokeswoman Susan Bro said von Eschenbach wanted to spend Tuesday's hearing less on this contentious issue and more on his own plans for the agency if confirmed as its chief.

"He knew it was critical that he be able to provide tomorrow a thoughtful approach to resolving what has been one of the most divisive issues the agency has faced in order for him to present his broad and ambitious vision for the FDA," Bro said.

Sens. Patty Murray, D-Washington, and Hillary Rodham Clinton, D-New York, vowed to continue holding up von Eschenbach's confirmation as commissioner until the agency makes a final decision, Murray spokeswoman Alex Glass said. The two had previously allowed von Eschenbach's predecessor, Lester Crawford, to be confirmed after receiving a pledge the FDA would act on the issue. Crawford resigned shortly after delaying a decision.

"Fool us once: We're not lifting this hold until a decision is made," Glass said.

If a woman already is pregnant, the pills have no effect. They prevent ovulation or fertilization of an egg. They also may prevent the egg from implanting into the uterus, considered the medical definition of pregnancy, although recent research suggests that's not likely.

Laws in eight states already allow women to buy Plan B from certain pharmacies without a prescription, with no age restrictions.

Barr shares climbed $2.42, or 5 percent, to $51.25 in morning trading on the New York Stock Exchange.

Copyright 2006 The Associated Press. All rights reserved.This material may not be published, broadcast, rewritten, or redistributed.


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This pill should be free and legal to anyone who wants it damnit!

and the FDA can kiss my ass in heeeeell!

[DirtyPool]

I sincerely hope the morning after pill is made illegal. Abortion should be ruled a crime and ALL abortion clinics should be shut down immediately.

[Sojiita]

We need a green light on the availability of this for the sake of women's reproductive freedom!

[Zee]

Dirty Pool are you against birth control pills as well? Or just the morning after pill-plan b?

[DirtyPool]

What we need is more effective birth control to PREVENT the pregnancy in the first place so we can put the abortion clinics out of business. hmmm, makes one wonder if the lobbying done by planned parenthood is a factor in why there hasn't been any significant improvements on birth control in the last several years. ALL birth control should be free and available in every high school, college, and hospital in America.

the morning after pill is in the same category as abortion.

[AliceInWonderland]

The morning after pill is NOT abortion Stupid!

[Zee]

Plan b is not the same as RU-486. It is essentially a high dose oral contraceptive. It is not an abortive agent and will not end a pregnancy. It prevents the pregnancy. So you are in essence for birth control- so what's the issue?

[DirtyPool]

The morning after pill is NOT abortion Stupid!

STUPID??? screw you. i was referring to the other controversial subject as the morning after pill!

[Zee]

the morning after pill is in the same category as abortion.

Nope- birth control. Couldn't get the morning after pill at pharmacy. They called my doctor and had a script called in for birth control pills. I took 5 or so at a time.

No implantion- no pregnancy- birth control.

[WhoAmI]

I took 5 or so at a time.

Just curious--did this make you feel sick? I don't even like to imagine kind of hormonal headache it might cause.

[Zee]

No headache. Didn't notice anything.

[Grimmlok]

Abortion has been around since the dawn of time. Closing abortion clinics will not end abortion, what part of that is so hard for neocons to understand?

Abortion clinics offer the service in a clean, professional and LICENCED environment. Getting rid of them and making abortion illegal will just see women in back alleys getting coat-hangars swished around their innards.

That's reality, neocons. Deal with it.

[Algernon]

If you are hard-core pro-life, then you should not use birth control (oral contraceptives) at all.

A dirty, little secret in the pharmaceutical world is that the Pill if taken in a certain way can actually work AFTER conception by preventing the embryo from implanting on the uterine wall. In other words, the pill can cause the baby to die. This is simply abortion by another name.
The "Morning After" Pill is nothing more than the regular birth control pill taken in massive dosage to insure that the embryo will not implant.

Although implantation prevention is apparently not the mechanism of action for the vast majority of women, especially for those who take the pill as prescribed, women who take birth control pills do risk the chance of aborting (killing) their unborn child.



http://www.christiananswers.net/q-eden/edn-bcpill.html

I had a friend who was pro life and refused to use bc pills because she learned that it could indeed keep a fertilized egg from implanting.

[Zee]

And if you are strict Catholic condoms are also out. So it's back to the rythmn method and the eventual pregnancy.

[A*O]

ALL birth control should be free and available in every high school, college, and hospital in America.

I agree - but unfortunately those same schools and colleges are no longer allowed to teach the kids how to use it.