Getbig.com: American Bodybuilding, Fitness and Figure
Getbig Main Boards => Politics and Political Issues Board => Topic started by: Dos Equis on April 22, 2009, 12:51:24 PM
-
Doesn't sound like a typical over-the-counter drug available to minors. I wonder if there are comparable drugs that minors can get without a prescription?
Official: FDA to Approve Plan B for 17-Year-Olds
An official said the agency will announce that it is complying with a federal judge's order that overturns a Bush administration policy.
AP
Wednesday, April 22, 2009
The Food and Drug Administration, reversing field, will now let 17-year-olds get the 'morning-after' birth control pill without a doctor's prescription, a government health official said Wednesday.
The official, who spoke on condition of anonymity, said the agency will announce that it is complying with a federal judge's order that overturns a Bush administration policy. The official was not authorized to speak publicly before the FDA announcement, expected later Wednesday.
Last month, U.S. District Judge Edward Korman ruled in a New York lawsuit that Bush administration appointees let politics, not science, drive their decision to allow over-the-counter access to these pills only for women 18 and older. Korman ordered the agency to let 17-year-olds get the medication, and separately to evaluate whether all age restrictions should be lifted.
Plan B is emergency contraception that contains a high dose of birth control drugs and will not interfere with an established pregnancy. Religious conservatives say it's the equivalent of an abortion pill because it can prevent a fertilized egg from attaching to the uterus.
The battle over access to Plan B has dragged on for the better part of a decade, through the tenure of three FDA commissioners. Among many in the medical community, it came to symbolize the decline of science at the agency. Top FDA managers refused to go along with the recommendations of scientific staff and outside advisers that the drug be made available over-the-counter with no age restrictions.
"The FDA got caught up in a saga, it got caught up in a drama," said Susan Wood, who served as the agency's top women's health official and resigned in 2005 over delays in issuing a decision. "This issue served as a clear example of the agency being taken off track, and it highlighted the problems FDA was facing in many other areas."
If taken within 72 hours of unprotected sex, Plan B can reduce a woman's chances of pregnancy by as much as 89 percent. It contains a high dose of birth control drugs and works by preventing ovulation, fertilization, or the implantation of a fertilized egg in the uterus.
If a woman is already pregnant, Plan B has no effect.
However, social conservatives say that since it can prevent the implantation of a fertilized egg, Plan B is the equivalent of an abortion pill.
The treatment consists of two pills and sells for about $35 to $60. Women must ask for Plan B at the pharmacy counter, and show identification with their date of birth. The drug is made by a subsidiary of Teva Pharmaceutical Industries, an Israeli company. It does not prevent sexually transmitted infections, including HIV/AIDS.
Supporters of broader access argued that Plan B was safe and effective in preventing unwanted pregnancy, and could also help reduce the number of abortions.
Opponents, including prominent conservatives, countered that it would encourage promiscuity, and might even become a tool for criminals running prostitution rings, as well as for sexual predators.
Early in the Bush administration, more than 60 organizations petitioned the FDA to allow sales without a prescription. But according to court documents, the issue quickly became politicized.
In 2003, a panel of outside advisers voted 23 to 4 to recommend over-the-counter sales without age restrictions. But top FDA officials told their subordinates that no approval could be issued at the time, and the decision would be made at a higher level. That's considered highly unusual, since the FDA usually has the last word on drug decisions.
In his ruling, Judge Korman said that FDA staffers were told the White House had been involved in the decision on Plan B. The government said in court papers that politics played no role.
In 2005, the Center for Reproductive Rights and other organizations sued in federal court to force an FDA decision.
The following year, the FDA allowed Plan B to be sold without a prescription to adults. But the controversy raged on over access for teens.
http://www.foxnews.com/politics/2009/04/22/official-fda-says-year-olds-morning-pill-prescription/
-
Terrible idea.
FDA Considers Over the Counter Status for “Morning After” Pill for Girls Under 17
By John Brandt
Published February 22, 2011
FoxNews.com
Less than two years after the Food and Drug Administration approved Plan B, the so-called “morning after pill” for over-the-counter access by women 17 years of age and older, the drug’s maker is now seeking to lift the age restrictions on the controversial product.
Teva Pharmaceuticals, Plan B’s maker, submitted data from a study in which girls ages 11 to 16 used the drug to prove its effectiveness and safety. Girls under 17 currently need a doctor’s prescription to obtain the drug.
“Parents should be very concerned that the FDA and the drug company are trying to sell this drug to minor girls without the parent’s knowledge or consent,” Wendy Wright of pro-life group Concerned Women for America told Fox News.
Teva says that the nature of the drug, which must be consumed within three days of unprotected sex to be effective, means many customers won’t have the ability to see a doctor quickly enough for what they deem an “emergency contraceptive,” to work correctly.
The drug uses a massive flood of hormones to prevent a fertilized egg from taking root in a woman’s uterus. Pro-life groups, which maintain that human life begins at conception, say that the drug actually ends pregnancies, rather than preventing them.
“We believe it is important that we remove all the barriers to obtaining Plan B One-Step so that anyone who needs it can get it as quickly as possible,” Teva spokeswoman Denise Bradley said.
Critics of the proposal say that selling the pill to minors over the counter eliminates important safeguards.
“In any case in which a minor girl would be seeking this drug, there needs to be an adult intervention,” said Wright. “There needs to be a doctor involved, who can find out if this girl is being abused.”
The general timeline for a drug to be re-classified from prescription to over-the-counter by the FDA is roughly 10 months, but each case is different. The agency performs a benefit-to-risk analysis and studies whether labeling instructions can be done so that consumers can safely use the drug without the intervention of a medical professional.
Supporters of the drug say the move is long overdue. After a court hearing to expand over-the-counter access for Plan B in November, Suzanne Novak, an attorney for the pro-choice Council for Reproductive Rights said the politicization of the issue needed to end.
"All of the scientific facts are there and FDA experts agree-emergency contraception has proven safe and effective to be sold over-the-counter to all ages," she argued.
Plan B has been a contentious issue for the FDA for some time. In 2005, the FDA official in charge of women’s health issues resigned in protest after the agency delayed a final ruling on whether the drug should be made more easily accessible.
http://www.foxnews.com/politics/2011/02/22/fda-considers-counter-status-morning-pill-girls-17/
-
this is just contraception
what's the problem?
-
Plan B?
We need more Option D.
If you are thinking of engaging in protected heterosexual sex, Billy Mimnaugh will come to your home and rape all of your male family members.
Best form of contraception available in America.
-
Great news.
-
Plan B?
We need more Option D.
If you are thinking of engaging in protected heterosexual sex, Billy Mimnaugh will come to your home and rape all of your male family members.
Best form of contraception available in America.
LOL. I miss Billy (no homo).
-
Brilliant. :-\
FDA Weighs Request to Put Morning-After Pill on Drugstore Shelves, Eliminate Age Restriction
Published December 05, 2011
FoxNews.com
The Food and Drug Administration reportedly is reviewing a request from morning-after pill Plan B's manufacturer to put the pill on drugstore and supermarket shelves, where it can be purchased without a prescription.
Plan B is currently available in the pharmacy department and requires women to produce either a prescription or proof that they are at least 17 in order to obtain the emergency contraception without a doctor's order, the Washington Post reports. Anyone younger than 17 need a prescription.
The request would make the drug readily available, even to children without a prescription. Such a move has its share of supporters but would also be sure to stoke controversy.
The request has been endorsed by some doctors, health advocates, family-planning activists and members of Congress who hope it will help prevent unwanted pregnancies.
"Hopefully it will be right on the shelves between the condoms and the pregnancy tests," Kirsten Moor of the Reproductive Health Technologies Project, a Washington-based advocacy group, told the Washington Post. "We think it's good news for women's health and long overdue."
But opponents argue making Plan B more accessible poses health risks to children because of the high dose of the hormone, and they have raised concerns about parents' ability to monitor their children.
"When anybody can buy an emergency contraceptive like this over the counter, you open the door for all sorts of abuse, and especially so when it comes to child abuse and child exploitation," Janice Crouse of Concerned Women of America told the Post.
The FDA has until Wednesday to respond to the request.
Plan B, which contains a high dose of a hormone found in many standard birth-control pills, can lower the risk of pregnancy by up to 89 percent if taken within 72 hours of unprotected sex.
Click here for more on this story from the Washington Post.
http://www.foxnews.com/health/2011/12/05/fda-weighs-request-to-put-morning-after-pill-on-drugstore-shelves/
-
I just hope the girls that use these pills know that isn't like taking an advil.....
-
I just hope the girls that use these pills know that isn't like taking an advil.....
hi, tom prince