_________________________By Lisa Richwine 1 hour, 57 minutes ago
WASHINGTON (Reuters) - A "morning-after" contraceptive can be sold to adults in the United States without a prescription, health officials ruled on Thursday, ending a three-year fight over wider access and use by teenagers.
The Food and Drug Administration said Barr Pharmaceuticals Inc.'s Plan B pills must stay behind pharmacy counters to prevent girls under 18 from getting the drug without a doctor's order.
Backers welcomed the decision but balked at the age limit, saying all females needed quick access in order for the pills to work. Two Plan B pills - sold by prescription since 1999 - can prevent pregnancy if taken soon after intercourse. The decision also angered conservatives, and some groups on both sides were girding to challenge the decision in court.
FDA officials said Plan B was safe and effective for women when taken as directed, but should not be used routinely. Women's groups said wider access could reduce unwanted pregnancies and abortions. Studies show Plan B cuts the chances of pregnancy by 89 percent if taken within 72 hours of sex. It works best when used within 24 hours.
"There's no scientific or medical reason" for the age limit, said Amy Allina, program director for the National Women's Health Network. Barr plans studies to back non-prescription use by a broader age group, said company spokeswoman Carol Cox. Conservative groups that fought wider availability said age enforcement was impossible. They worry it could increase promiscuity and sexually transmitted diseases, particularly among teenagers.
The Family Research Council, a Christian lobbying group, said the FDA overreached and it would pursue legal and legislative options. Women who have sued the FDA over repeated delays on Plan B said they would fight in court to have the age limit lifted. The FDA said women and men must show proof of age to buy the emergency contraceptive without a prescription, and younger girls still need a doctor's order.
Barr agreed to monitor age enforcement and limit Plan B distribution to health clinics and stores with pharmacies. Nonprescription packaging should be available by year's end.
Barr has not set a price for non-prescription Plan B, Cox said. The prescription product now sells for about $25 to $40. Aimee Hess, a health-care analyst at Rochdale Research, said Plan B was a modest-sized product for Barr with estimated annual sales of about $30 million. "Sales could double within the next year or two, and a major emotional issue has been dealt with," Hess said. Approval prompted Democratic Senators Patty Murray of Washington and Hillary Rodham Clinton of New York to end their objection to a Senate confirmation vote on President George W. Bush President's pick to run the FDA, acting Commissioner Andrew von Eschenbach. Murray, Clinton and other Plan B supporters argued that repeated delays since the initial application in April 2003 were triggered by politics rather than scientific concerns.
FDA approval came three days after Bush said he supported the age limit on nonprescription sales.
"The FDA made clear that it will insist on stringent conditions and restrictions on access to reduce both health risks and opportunities for abuse, especially to protect minors," White House spokeswoman Dana Perino said.
Emergency contraceptives are available without a prescription in about 40 countries. Nine U.S. states already allow access by those of any age through pharmacists.
Plan B pills contain higher doses of progestin, a hormone used in prescription birth-control pills for 35 years. Women are supposed to take the two tablets 12 hours apart. Like prescription birth control pills, Plan B blocks the release or fertilization of an egg. Some research suggests the hormone also may keep a fertilized egg from attaching to the womb, and some opponents liken that mechanism to 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. Barr stock closed down 20 cents at $57.77 a share on the New York Stock Exchange on Thursday.
Backers welcomed the decision but balked at the age limit, saying all females needed quick access in order for the pills to work. Two Plan B pills - sold by prescription since 1999 - can prevent pregnancy if taken soon after intercourse. The decision also angered conservatives, and some groups on both sides were girding to challenge the decision in court.
FDA officials said Plan B was safe and effective for women when taken as directed, but should not be used routinely. Women's groups said wider access could reduce unwanted pregnancies and abortions. Studies show Plan B cuts the chances of pregnancy by 89 percent if taken within 72 hours of sex. It works best when used within 24 hours.
"There's no scientific or medical reason" for the age limit, said Amy Allina, program director for the National Women's Health Network. Barr plans studies to back non-prescription use by a broader age group, said company spokeswoman Carol Cox. Conservative groups that fought wider availability said age enforcement was impossible. They worry it could increase promiscuity and sexually transmitted diseases, particularly among teenagers.
The Family Research Council, a Christian lobbying group, said the FDA overreached and it would pursue legal and legislative options. Women who have sued the FDA over repeated delays on Plan B said they would fight in court to have the age limit lifted. The FDA said women and men must show proof of age to buy the emergency contraceptive without a prescription, and younger girls still need a doctor's order.
Barr agreed to monitor age enforcement and limit Plan B distribution to health clinics and stores with pharmacies. Nonprescription packaging should be available by year's end.
Barr has not set a price for non-prescription Plan B, Cox said. The prescription product now sells for about $25 to $40. Aimee Hess, a health-care analyst at Rochdale Research, said Plan B was a modest-sized product for Barr with estimated annual sales of about $30 million. "Sales could double within the next year or two, and a major emotional issue has been dealt with," Hess said. Approval prompted Democratic Senators Patty Murray of Washington and Hillary Rodham Clinton of New York to end their objection to a Senate confirmation vote on President George W. Bush President's pick to run the FDA, acting Commissioner Andrew von Eschenbach. Murray, Clinton and other Plan B supporters argued that repeated delays since the initial application in April 2003 were triggered by politics rather than scientific concerns.
FDA approval came three days after Bush said he supported the age limit on nonprescription sales.
"The FDA made clear that it will insist on stringent conditions and restrictions on access to reduce both health risks and opportunities for abuse, especially to protect minors," White House spokeswoman Dana Perino said.
Emergency contraceptives are available without a prescription in about 40 countries. Nine U.S. states already allow access by those of any age through pharmacists.
Plan B pills contain higher doses of progestin, a hormone used in prescription birth-control pills for 35 years. Women are supposed to take the two tablets 12 hours apart. Like prescription birth control pills, Plan B blocks the release or fertilization of an egg. Some research suggests the hormone also may keep a fertilized egg from attaching to the womb, and some opponents liken that mechanism to 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. Barr stock closed down 20 cents at $57.77 a share on the New York Stock Exchange on Thursday.
(Additional reporting by Susan Heavey in Washington and Ransdell Pierson in New York)
____________________________________________________________________
Be prepared folks, the holy rollers are going to start having strokes in droves now. Yes, women now have yet another option when confronted with unwated fish donations, they can stop them from being harvested! I know, this is going to be a heavy blow to masses of controlling, abusive, egotistical, womanizing men around the United States, all I can say is, "Suck it up boys!" Men love to cry about things of this nature, yet they fail to accept the responsibility for having lied, manipulated, threatened, and coerced women for decades into having sexual intercourse without condoms. Women have suffered not just unwated pregnacies and painful abortions as a consequence to these actions, but also numerous sexually transmitted diseases. Now we have entered a new age, where women are gaining more and more control over their lives, and their bodies, despite the oppression that has been forced upon us by males with a neanderthal thought proccess. For all of the people, namely men, who want less abortions, use condoms always!
Just my thoughts.
Posts
2 comments:
You are quite right April . As I was driving my son home from marching band, the christian stations were all abuzz with this new move from the FDA and the stem cell discovery that was announced today. They denounced the FAA as criminals and were hoping that Congress intervenes. I'm sure the lobbyists in Congress and the clergy are ablaze with condemnation. Luckily it was a short ride home. I can't handle too much of their crap. I mostly listen for the laugh and craziness of the views. I guess we should stay tuned.
Well said April!!!! It is way pass due for women to be allowed to have a say with their bodies. I'm sure most that will fight this will in fact be men. What gets me is these same men augue they shouldn't have to be responsible for children that are born.
Also right to lifers although they preach against any form of birth control and/or abortions, they will be the first to admit they don't have a desire to support any unwanted children, their job is finished when they force their beliefs on another.
Men need to keep quiet on what choices a woman is allowed to have over thier own bodies. Till the day a man can be pregnant, feel the sickness, and pain involed, until they have to skimp and save to feed a child when the 'other parent' skips out, until men know the loniness and fear of having to raise a child with no support, they need to keep their mouthes shut.
As far as religious fanatics when they can take the pain, shame, and cost of unwanted pregnancies they too need to keep thier mouthes shut.
In the bible it says 'judge not less you be judge', yet so many "christains" forget this when they are force feeding their beleifs to others.
Awesome post April, so great to have you aboard the Ratttler, hope you have your seltbelt on it can be a bumpy ride at times, but it sure is fun :>)
Post a Comment