FDA CONSIDERS ALLOWING MORNING AFTER PILL TO BE SOLD OVER THE COUNTER

9th Engineer · 08-10-2006, 10:54 PM

No big loss. If we had stopped Reeve from misinforming so many people about it it wouldn't be so bad.

xoxoxoBruce · 08-12-2006, 07:30 AM

Quote:

Originally Posted by 9th Engineer

No big loss. If we had stopped Reeve from misinforming so many people about it it wouldn't be so bad.

Whoa, there's been a hell of a lot of information floating around, and continues to be forthcoming, that has nothing to do with Reeve. You don't believe it?

9th Engineer · 08-14-2006, 03:54 PM

I'm making more of a reference to the information used during the last election. Reeve made rounds with the Democrats playing up Bush's opposition to using federal money for stem cell research. He made outragous statements leading people to believe that people like him 'could have a cure' if only Bush wasn't stopping it. Complete bullshit. The state of the technology is this, we want to learn what it is about totipotent and pluripotent cells that allows them to become very specialized structures such as muscle or nerve bundles. They were giving people the idea that this would logically lead to the growing of whole organs and tissue replacements within a localized timeframe. That would have been like a scientist saying we need to research transistors so that we can build human-level AI systems.
I'm just saying he gave alot of people a very unrealistic view of what we can do or intend to do once given the ok with this.

9th Engineer · 08-14-2006, 04:14 PM

I'm also ticked that everyone thinks this is all Bush's doing, it was Clinton and the Dickey Ammendment which made it illegal to use federal money to fund stem cell research which involves destroying an embryo.

08-25-2006, 01:00 PM

Morning-after pill to be available without prescription
Buyers must prove they're 18 or older

Friday, August 25, 2006; Posted: 1:28 a.m. EDT (05:28 GMT)

Plan B will be available over the counter to women 18 or older, the Food and Drug Administration says.

Differences between the morning-after pill and the abortion pill, which are different drugs:

The morning-after pill prevents pregnancy but has no effect if a woman already is pregnant. Sold under the brand name Plan B, it's a higher-than-normal dose of a hormone found in regular birth-control pills and prevents ovulation or fertilization of an egg. It also may prevent the egg from implanting into the uterus, the medical definition of pregnancy, but recent research suggests that's not likely.

The abortion pill, RU-486 or Mifeprex, can terminate pregnancy up to 49 days after the beginning of the last menstrual cycle. It's a two-pill process. First is Mifeprex, which blocks production of a hormone required to sustain pregnancy. Then a second medicine, misoprostol, to cause contractions and finish the abortion.
WASHINGTON (AP) -- Women can buy the morning-after pill without a prescription, the government declared Thursday, a major step that nevertheless failed to quell the politically charged debate over access to emergency contraception.

The manufacturer, lawmakers and other advocates said they will press the government to allow minors to purchase the pills over the counter.

The Food and Drug Administration said that women 18 and older -- and men purchasing for their partners -- may buy the Plan B pills without a doctor's note, but only from pharmacies.

Girls 17 and younger still will need a prescription to buy the pills, the FDA told manufacturer Barr Pharmaceuticals Inc., in ruling on an application filed in 2003.

Still at odds
The compromise decision is a partial victory for women's advocacy and medical groups, which say easier access could halve the nation's 3 million annual unplanned pregnancies.

"While we are glad to know the FDA finally ended its foot-dragging on this issue, Planned Parenthood is troubled by the scientifically baseless restriction imposed on teenagers. The U.S. has one of the highest rates of teen pregnancy in the Western world -- anything that makes it harder for teenagers to avoid unintended pregnancy is bad medicine and bad public policy," president Cecile Richards said.

Opponents contend that nonprescription availability could increase promiscuity and promote use of the pills by sexual predators.

"If the FDA thinks that enacting an age restriction will work, or that the drug company will enforce it ... then they are living in a dream world," said Wendy Wright, president of Concerned Women for America, who led the opposition.

Pregnancy risk reduced
Plan B contains a concentrated dose of the same drug found in many regular birth-control pills. Planned Parenthood estimates 41 other countries already allow women to buy emergency contraception without a prescription.

If a woman takes Plan B within 72 hours of unprotected sex, she can lower the risk of pregnancy by up to 89 percent. Plan B is different from the abortion pill: If a woman already is pregnant, Plan B has no effect.

The earlier the pills are taken, the more effective they are. Allowing nonprescription sales mean women won't have to hustle to get a prescription, something especially difficult on weekends and holidays, advocates said.

The FDA's long delay in deciding on Barr's application ensnared President Bush's nominee to head the regulatory agency. On Thursday, two senators said they would lift their Plan-B-related block on Dr. Andrew von Eschenbach.

In recent weeks, anti-abortion groups, angered that approval was imminent, had urged Bush to withdraw von Eschenbach's nomination. Bush said Monday that he supported the doctor's decisions.

Only at pharmacies
Barr hopes to begin nonprescription sales of Plan B by the end of the year. The pills will be sold only from behind the counter at pharmacies, but not at convenience stores or gas stations. Pharmacists will check photo identification.

There isn't enough scientific evidence that young teens can safely use Plan B without a doctor's supervision, von Eschenbach said in a memo. Over-the-counter use is safe for older teens and adults, the acting FDA commissioner added in explaining the age cutoff.

"This approach should help ensure safe and effective use of the product," wrote von Eschenbach.

Barr and others were disappointed that FDA imposed the age restriction. Bruce L. Downey, Barr's chairman, pledged to continue working with the agency to try to eliminate it.

The age restriction remains controversial even inside FDA, agency drugs chief Dr. Steven Galson told The Associated Press. Galson has acknowledged overruling his staff scientists, who concluded in 2004 that nonprescription sales would be safe for all ages.

"Let me be frank, there still are disagreements," Galson said in an interview. "There were disagreements from the first second this application came in the house."

The Center for Reproductive Rights said a lawsuit filed last year to do away with all age restrictions would continue.

Age-limit enforcement
As a condition of approval, Barr agreed to use anonymous shoppers and other methods to check whether pharmacists are enforcing the age restriction.

"I'm sure the FDA will follow through on that and make sure these important conditions are established and enforced," said White House spokeswoman Dana Perino.

Barr hasn't said whether it will raise the price of the pills, which now cost $25 to $40 in prescription form.

Planned Parenthood, the largest dispenser of the pills, expects some insurers to continue covering prescription sales. Whether that would be cheaper will depend on a woman's insurance.

Nine states -- Alaska, California, Hawaii, Maine, Massachusetts, New Hampshire, New Mexico, Washington and Vermont -- already allow certain pharmacies to sell Plan B without a doctor's prescription to women of any age.

Minors won't see any change in those states, because the pharmacist already technically writes the prescription, the American Pharmacists Association said.

The FDA approved prescription-only sales of Plan B in 1999. The quest to change its status began in 2003. That year, agency advisers endorsed nonprescription sales for all ages, and FDA's staff scientists agreed.

Higher-ranking officials rejected that recommendation, citing concerns about young teens using the pills without oversight. Barr reapplied, asking that women 16 and older be allowed to buy Plan B without a prescription. Then last August, the FDA postponed a final decision indefinitely, saying the agency needed to determine how to enforce the age restrictions.

FDA's handling of Plan B sparked a firestorm, with allegations of political meddling, high-profile resignations, lawsuits and congressional investigations.

The controversy appears to have helped Plan B sales, which are up an estimated 30 percent this year, according to IMS Health Inc., a health care consulting company. Barr estimates pharmacists dispense about 1.5 million packs a year.

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

Sundae · 08-27-2006, 01:37 PM

Obviously it's a Yay! from me, but I wonder if it will actually make any difference. I admit ignorance on the way your legal system works, but I guess if 9 States had already legalised it, then surely if the others wanted to they would have? I also seem to remember something on TV that suggested while abortion is legal, one State (one of the Dakotas maybe?) now had no Doctors willing to perform the procedure, and in fact the only willing Doctor covered 3 States and was about to retire. This is from memory, but am pretty sure that was the case.

The only other comment I can make is that I don't think statistics bear out the assumption the morning after pill reduces teenage pregnancy. Again, I may be wrong, but my PCT has one of the highest teenage pregnancy rates in the country and as stated before we were running a free of charge OTC service... EHC mops up after responsible people who worry about unsafe sex and whether they are pregnant. [generalisation] That doesn't seem to include most teenage mothers. [/generalisation]

I say get them all fitted with a 3 year implant. I'm only half joking (I have one myself)

08-10-2006, 10:54 PM	#1
9th Engineer Bioengineer and aspiring lawer Join Date: Apr 2006 Location: Pittsburgh Posts: 872	No big loss. If we had stopped Reeve from misinforming so many people about it it wouldn't be so bad. __________________ The most valuable renewable resource is stupidity.

08-14-2006, 03:54 PM	#3
9th Engineer Bioengineer and aspiring lawer Join Date: Apr 2006 Location: Pittsburgh Posts: 872	I'm making more of a reference to the information used during the last election. Reeve made rounds with the Democrats playing up Bush's opposition to using federal money for stem cell research. He made outragous statements leading people to believe that people like him 'could have a cure' if only Bush wasn't stopping it. Complete bullshit. The state of the technology is this, we want to learn what it is about totipotent and pluripotent cells that allows them to become very specialized structures such as muscle or nerve bundles. They were giving people the idea that this would logically lead to the growing of whole organs and tissue replacements within a localized timeframe. That would have been like a scientist saying we need to research transistors so that we can build human-level AI systems. I'm just saying he gave alot of people a very unrealistic view of what we can do or intend to do once given the ok with this. __________________ The most valuable renewable resource is stupidity.

08-14-2006, 04:14 PM	#4
9th Engineer Bioengineer and aspiring lawer Join Date: Apr 2006 Location: Pittsburgh Posts: 872	I'm also ticked that everyone thinks this is all Bush's doing, it was Clinton and the Dickey Ammendment which made it illegal to use federal money to fund stem cell research which involves destroying an embryo. __________________ The most valuable renewable resource is stupidity.

08-27-2006, 01:37 PM	#6
Sundae polaroid of perfection Join Date: Sep 2005 Location: West Yorkshire Posts: 24,185	Obviously it's a Yay! from me, but I wonder if it will actually make any difference. I admit ignorance on the way your legal system works, but I guess if 9 States had already legalised it, then surely if the others wanted to they would have? I also seem to remember something on TV that suggested while abortion is legal, one State (one of the Dakotas maybe?) now had no Doctors willing to perform the procedure, and in fact the only willing Doctor covered 3 States and was about to retire. This is from memory, but am pretty sure that was the case. The only other comment I can make is that I don't think statistics bear out the assumption the morning after pill reduces teenage pregnancy. Again, I may be wrong, but my PCT has one of the highest teenage pregnancy rates in the country and as stated before we were running a free of charge OTC service... EHC mops up after responsible people who worry about unsafe sex and whether they are pregnant. [generalisation] That doesn't seem to include most teenage mothers. [/generalisation] I say get them all fitted with a 3 year implant. I'm only half joking (I have one myself) __________________ Life's hard you know, so strike a pose on a Cadillac

08-25-2006, 01:00 PM	#5
rkzenrage Guest Posts: n/a	Morning-after pill to be available without prescription Buyers must prove they're 18 or older Friday, August 25, 2006; Posted: 1:28 a.m. EDT (05:28 GMT) Plan B will be available over the counter to women 18 or older, the Food and Drug Administration says. Differences between the morning-after pill and the abortion pill, which are different drugs: The morning-after pill prevents pregnancy but has no effect if a woman already is pregnant. Sold under the brand name Plan B, it's a higher-than-normal dose of a hormone found in regular birth-control pills and prevents ovulation or fertilization of an egg. It also may prevent the egg from implanting into the uterus, the medical definition of pregnancy, but recent research suggests that's not likely. The abortion pill, RU-486 or Mifeprex, can terminate pregnancy up to 49 days after the beginning of the last menstrual cycle. It's a two-pill process. First is Mifeprex, which blocks production of a hormone required to sustain pregnancy. Then a second medicine, misoprostol, to cause contractions and finish the abortion. WASHINGTON (AP) -- Women can buy the morning-after pill without a prescription, the government declared Thursday, a major step that nevertheless failed to quell the politically charged debate over access to emergency contraception. The manufacturer, lawmakers and other advocates said they will press the government to allow minors to purchase the pills over the counter. The Food and Drug Administration said that women 18 and older -- and men purchasing for their partners -- may buy the Plan B pills without a doctor's note, but only from pharmacies. Girls 17 and younger still will need a prescription to buy the pills, the FDA told manufacturer Barr Pharmaceuticals Inc., in ruling on an application filed in 2003. Still at odds The compromise decision is a partial victory for women's advocacy and medical groups, which say easier access could halve the nation's 3 million annual unplanned pregnancies. "While we are glad to know the FDA finally ended its foot-dragging on this issue, Planned Parenthood is troubled by the scientifically baseless restriction imposed on teenagers. The U.S. has one of the highest rates of teen pregnancy in the Western world -- anything that makes it harder for teenagers to avoid unintended pregnancy is bad medicine and bad public policy," president Cecile Richards said. Opponents contend that nonprescription availability could increase promiscuity and promote use of the pills by sexual predators. "If the FDA thinks that enacting an age restriction will work, or that the drug company will enforce it ... then they are living in a dream world," said Wendy Wright, president of Concerned Women for America, who led the opposition. Pregnancy risk reduced Plan B contains a concentrated dose of the same drug found in many regular birth-control pills. Planned Parenthood estimates 41 other countries already allow women to buy emergency contraception without a prescription. If a woman takes Plan B within 72 hours of unprotected sex, she can lower the risk of pregnancy by up to 89 percent. Plan B is different from the abortion pill: If a woman already is pregnant, Plan B has no effect. The earlier the pills are taken, the more effective they are. Allowing nonprescription sales mean women won't have to hustle to get a prescription, something especially difficult on weekends and holidays, advocates said. The FDA's long delay in deciding on Barr's application ensnared President Bush's nominee to head the regulatory agency. On Thursday, two senators said they would lift their Plan-B-related block on Dr. Andrew von Eschenbach. In recent weeks, anti-abortion groups, angered that approval was imminent, had urged Bush to withdraw von Eschenbach's nomination. Bush said Monday that he supported the doctor's decisions. Only at pharmacies Barr hopes to begin nonprescription sales of Plan B by the end of the year. The pills will be sold only from behind the counter at pharmacies, but not at convenience stores or gas stations. Pharmacists will check photo identification. There isn't enough scientific evidence that young teens can safely use Plan B without a doctor's supervision, von Eschenbach said in a memo. Over-the-counter use is safe for older teens and adults, the acting FDA commissioner added in explaining the age cutoff. "This approach should help ensure safe and effective use of the product," wrote von Eschenbach. Barr and others were disappointed that FDA imposed the age restriction. Bruce L. Downey, Barr's chairman, pledged to continue working with the agency to try to eliminate it. The age restriction remains controversial even inside FDA, agency drugs chief Dr. Steven Galson told The Associated Press. Galson has acknowledged overruling his staff scientists, who concluded in 2004 that nonprescription sales would be safe for all ages. "Let me be frank, there still are disagreements," Galson said in an interview. "There were disagreements from the first second this application came in the house." The Center for Reproductive Rights said a lawsuit filed last year to do away with all age restrictions would continue. Age-limit enforcement As a condition of approval, Barr agreed to use anonymous shoppers and other methods to check whether pharmacists are enforcing the age restriction. "I'm sure the FDA will follow through on that and make sure these important conditions are established and enforced," said White House spokeswoman Dana Perino. Barr hasn't said whether it will raise the price of the pills, which now cost $25 to $40 in prescription form. Planned Parenthood, the largest dispenser of the pills, expects some insurers to continue covering prescription sales. Whether that would be cheaper will depend on a woman's insurance. Nine states -- Alaska, California, Hawaii, Maine, Massachusetts, New Hampshire, New Mexico, Washington and Vermont -- already allow certain pharmacies to sell Plan B without a doctor's prescription to women of any age. Minors won't see any change in those states, because the pharmacist already technically writes the prescription, the American Pharmacists Association said. The FDA approved prescription-only sales of Plan B in 1999. The quest to change its status began in 2003. That year, agency advisers endorsed nonprescription sales for all ages, and FDA's staff scientists agreed. Higher-ranking officials rejected that recommendation, citing concerns about young teens using the pills without oversight. Barr reapplied, asking that women 16 and older be allowed to buy Plan B without a prescription. Then last August, the FDA postponed a final decision indefinitely, saying the agency needed to determine how to enforce the age restrictions. FDA's handling of Plan B sparked a firestorm, with allegations of political meddling, high-profile resignations, lawsuits and congressional investigations. The controversy appears to have helped Plan B sales, which are up an estimated 30 percent this year, according to IMS Health Inc., a health care consulting company. Barr estimates pharmacists dispense about 1.5 million packs a year. Copyright 2006 The Associated Press. All rights reserved.This material may not be published, broadcast, rewritten, or redistributed.

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