FDA approves over-the-counter sales for Plan B

Women and girls age 15 and over will soon be able to buy emergency contraception without a prescription.

The Food and Drug Administration announced on Tuesday that it was approving Plan B One-Step, also known as the morning-after pill, to be sold in the retail aisle next to other over-the-counter medications. Customers will not have to ask a pharmacist for it.

FDA officials say the announcement is unrelated to a federal judge's order earlier this month, which gave the agency 30 days to make the pill available to all girls and women without a prescription, regardless of age.

Until now, women have had to ask a pharmacist for emergency contraception. Those under 17 could get the pill only with a prescription.

In his April 5th ruling,U.S. District Court Judge Edward Korman noted that emergency contraception has been shown to be extremely safe, and that the FDA's age limits were arbitrary.

"FDA has engaged in intolerable delays," Korman said, amounting to an "administration agency filibuster."

Korman's ruling was in response to a lawsuit by the Center for Reproductive Rights, which sued to expand access to emergency contraception, which can prevent pregnancy if taken within three days of unprotected sex or contraceptive failure.

Plan B One-Step, a single pill containing a hormone found in birth control pills, sold by Teva Women's Health, does not terminate an existing pregnancy and does not harm a developing fetus, the FDA said.

About half of pregnancies are unintended, studies show.

FDA spokeswoman Erica Jefferson said the Tuesday approval "is independent of the judge's ruling and is not intended to address it."

In an interview with USA TODAY's Editorial Board last week, FDA Commissioner Margaret Hamburg said the agency had not yet decided how to respond to the judge's order. Jefferson said the Department of Justice handles litigation, and said all questions about the judge's order should be referred to that agency.

Now, customers will be able to buy Plan B One-Step just as they would purchase condoms. But girls will have to show an ID to prove their age, the FDA said.

"The FDA is under a federal court order that makes it crystal clear that emergency contraception must be made available over the counter, without restriction to women of all ages by next Monday," said Nancy Northup, president and CEO of the Center for Reproductive Rights, in a statement.

"Lowering the age restriction to 15 for over-the-counter access to Plan B One-Step may reduce delays for some young women — but it does nothing to address the significant barriers that far too many women of all ages will still find if they arrive at the drugstore without identification or after the pharmacy gates have been closed for the night or weekend. These are daunting and sometimes insurmountable hoops women are forced to jump through in time-sensitive circumstances, and we will continue our battle in court to remove these arbitrary restrictions on emergency contraception for all women."

Emergency contraception has had a long history with the FDA. The drug was first approved in 1993.

In 2011, the FDA was about to approve an application from its manufacturer, Teva Women's Health, to sell it over the counter. President Obama expressed concerns, however, and Secretary of Health and Human Secretary Kathleen Sebelius overruled the FDA.

When its application to sell Plan B One-Step over-the-counter without age restrictions was rejected, Teva submitted a new application, requesting approval for those 15 and up, the FDA said.

That application, asking for approval for those 15 and up, was filed before the judge's ruling, Jefferson said.

At the time of the judge's ruling, the Family Research Council's Anna Higgins said, "Making Plan B available for girls under the age of 17 without a prescription flies in the face of medical information and sound judgment."

Higgins also expressed concern that the over-the-counter availability of Plan B for girls of any age would put many at further risk of sexually transmitted infections.

In a statement, Planned Parenthood Federation of America officials praised the FDA's decision, although the group also encouraged the FDA to lift all restrictions on emergency contraception, as mandated by the court.

"While there are still practical questions to resolve, this is an important step forward to expand access to emergency contraception and for preventing unintended pregnancy," Planned Parenthood President Cecile Richards said. "This decision will eliminate some of the biggest barriers and hurdles that women face in getting emergency contraception when they need it, which means many more women will be able to prevent unintended pregnancy."

Other forms of emergency contraception have been approved. A two-dose version of Plan B is available generically and available to women 17 and up without a prescription. It requires a prescription for girls under age 17. Another version, sold as Ella, is sold only with a prescription and is approved to prevent pregnancy within five days of unprotected sex or contraceptive failure.

Article Source - http://www.usatoday.com/story/news/nation/2013/04/30/fda-plan-b-over-the-counter-emergency-contraception/2125131/

What Everyone Ought to Know About Obesity

Obesity has become a real problem in a lot of countries, however the US is the most obese country in the world, and the medical profession have started to worry about the additional stress it’s putting on the health service. The US is famous for consumerism, and it’s not difficult to find a fast food restaurant wherever people happen to live.

It’s not just food that’s the problem it’s the way that people live their lives generally. There are so many gadgets about these days in terms of entertainment people often spend hours on their computers playing games. It’s also hard to fit exercise in if you work an office job, sitting at a desk all day won’t exactly get those muscles working, and people often cannot be bothered to go and visit a gym at the end of the day.

The fact is we’re becoming a nation of “couch potatoes”.  Some might say we already are! The problem with obesity is once a person has reached this level, it’s hard to find a way out. Low self-esteem sets in, energy levels are low, and people even start to suffer from depression.

People who are obese probably don’t realize just how much strain their putting on their internal organs. The heart has to work harder, which means people are more at risk of heart disease. Carrying extra weight around also puts more pressure on the joints.

Skin problems can also start to raise their ugly little heads. Things like Psoriasis, skin tags and warts start to appear. To be honest it’s really not pretty, and if anyone reading this has been told they’re obese, it’s time to do something about it. You’re not doing yourself any favors, and it’s likely you will die much younger than someone who is at an acceptable weight level.

The expressions “big is beautiful” or “I have a problem with metabolism” really doesn’t cut it with most people who are obese. Of course, there are people with metabolic problems, but the medical profession can do things to help this. Some people may also be happy with the fact they’re big, but there is a very fine line between being healthy and big, and being obese.

These words may seem harsh, but a wake-up call is what’s needed. Just take a moment to think about family and friends? How would they feel if you’re life ended simply because you didn’t address the problem with your weight?

The fact is the health issues that come hand in hand with obesity can be really serious. If you’re in a situation where you’re feeling totally alone because of your weight start by joining forums on the internet, this will be your first step to getting some help. You’ll be surprised at just how many people are feeling just like you are.
It cannot be stressed enough how important it is that obese people take the problem “by the horns” and do something about it. Who wants to spend most of their life in a hospital having to undergo a hip replacement or some other sort of surgery because they’re obese, the answer is NO-ONE does!