Monday, December 12, 2011

Secretary Sebelius Vetoes FDA and Blocks Plan B

Plan B Blocked By Health and Human Services Secretary Kathleen Sebelius

I would like to start this post by asking you three questions.......

Abstinence or Safe Sex?
Birth Control or Abortion?
Pregnant Teenage Girl or Young Scientist Who Discovers the Cure for Cancer?

I think it's time we get out of our backwards way of thinking, forget the past and move into the present. It's time we fully understand the lives that our youth are living today. Crawl out from underneath your rock, put your bible down and put an end to all judgment.


Parents need to stop pretending that this activity is not taking place amongst our youth and change course. Teaching abstinence is NOT effective and blocking young women from accessing various forms of contraceptives is not the way to go.

The Food and Drug Administration determined that Plan B (also known as the "Morning After Pill") was safe enough to have relaxed restrictions allowing over-the-counter usage. On Wednesday, December 7, Health and Human Services Secretary Kathleen Sebelius made a decision that has never taken place before, to overrule the FDA's decision to make the Plan B drug available to all with no restrictions. Secretary Sebelius made this statement......

Plan B One-Step is an emergency contraceptive, sometimes referred to as the “morning after pill.” Plan B One-Step is currently labeled over the counter to women ages 17 years and older, but is sold behind the pharmacy counter. It is available by prescription only to women 16 years and younger. My decision does not change any current availability of the drug for all women.

In February 2011, Teva Women’s Health Inc. submitted to the FDA a supplemental new drug application for Plan B One-Step. This application sought to make Plan B One-Step available over the counter for all girls of reproductive age. The science has confirmed the drug to be safe and effective with appropriate use. However, the switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately. I do not believe that Teva’s application met that standard. The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use.

FDA has recommended approval of this application in its Summary Review for Regulatory Action on Plan B One-Step. After careful consideration of the FDA Summary Review, I have concluded that the data, submitted by Teva, do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age.

The average age of the onset of menstruation for girls in the United States is 12.4 years. However, about ten percent of girls are physically capable of bearing children by 11.1 years of age. It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age. If the application were approved, the product would be available, without prescription, for all girls of reproductive age.

The Secretary of the Department of Health and Human Services is responsible, acting through the FDA Commissioner, for executing the Federal Food, Drug, and Cosmetic Act. Today’s action reflects my conclusion that the data provided as part of the actual use study and the label comprehension study are not sufficient to support making Plan B One-Step available to all girls 16 and younger, without talking to a health care professional. Plan B One-Step will still be available over the counter to women ages 17 and older.

Because I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age, I have directed FDA to issue a complete response letter denying the supplemental new drug application (SNDA) by Teva Women’s Health, Inc.

I want to slap Secretary Sebelius in the face! This is NOT a justification for making the drug unavailable to all women. This is purely political and absolute nonsense. The label is not comprehensible to girls under 17? Is this really the reason that Secretary Sebelius is giving us as to why Plan B should not be accessible to all women, regardless of age.

It gets even better.......

Here is President Obama speaking out against the very decision Secretary Sebelius just made - politics over science.

President Barack Obama on Thursday said he didn't intervene in a decision by his top health official to overrule the Food and Drug Administration commissioner to block the Plan B emergency contraceptive pill from becoming available to young teens without a prescription, though he said he agrees with the action.

In a briefing with White House reporters, Mr. Obama said Health and Human Services Secretary Kathleen Sebelius made her own decision Wednesday to step in and prevent the FDA from approving a request by the drug's manufacturer, Teva Pharmaceutical Industries, to remove the current requirement that girls under age 17 need a prescription for the drug.

"I will say this, as the father of two daughters. I think it is important for us to make sure that, you know, we apply some common sense to various rules when it comes to over-the-counter medicine," Mr. Obama said. The president's daughters are ages 13 and 10.

WOW! Really President Obama! What a punk move!

President Obama had no problem in September intervening in a decision made by Lisa Jackson, Environmental Protection Agency Administrator, when he put the axe on plans to impose stricter ozone pollution standards. This was a plan that would have saved lives and allowed us to live on a cleaner planet. This was a decision he should have supported, but he didn't. So now he has no forces left in him to intervene in this decision, which completely goes against rules he himself set in 2009.

In March 2009, President Obama issued a Scientific Integrity Memorandum which effectively said that science shouldn't have restrictions placed for political reasons. Secretary Sebelius' decision was purely political and the President's decision to standby and let her make it was purely political also.

I am fully aware that there are other methods of birth control that a young woman has at 16 years-old. However, I can't support the limiting of options to young woman. Young women are sexually active at age 16 and that's a fact. When we make asinine decisions like this, it sends a conflicting message to our young women and to young women across the globe.

We have one side of the aisle who wants to ban abortions in all cases, including incest and rape. They also want to limit birth control and access to sexual health and reproductive caretakers like Planned Parenthood. So effectively that side wants young women to have access to nothing, leaving them with no options. Now we have the other side joining that gang by beginning to limit the options that a young woman has. This was the wrong decision and a very bad one. We've now opened the flood gates for Governors to continue to pass legislation that further limits a woman's options and rights to choose. We have to find common ground on this and make the options limitless and easy for young women. I ask again, Abortion or Birth Control? My guess would be the Plan B and it should be available to all. But don't take my word on this.

Interesting Facts from the Center for Disease Control and Prevention on Teenage Pregnancy in the United States:
  • In 2009, a total of 409,840 infants were born to 15−19 year olds, for a live birth rate of 39.1 per 1,000 women in this age group.
  • Nearly two-thirds of births to women younger than age 18 and more than half of those among 18−19 year olds are unintended.
  • The US teen birth rate fell by more than one-third from 1991 through 2005, but then increased by 5 percent over two consecutive years.
  • Teen pregnancy accounts for more than $9 billion per year in costs to U.S. taxpayers for increased health care and foster care, increased incarceration rates among children of teen parents, and lost tax revenue because of lower educational attainment and income among teen mothers.
  • Pregnancy and birth are significant contributors to high school drop out rates among girls. Only about 50% of teen mothers receive a high school diploma by age 22, versus nearly 90% of women who had not given birth during adolescence.
  • The children of teenage mothers are more likely to have lower school achievement and drop out of high school, have more health problems, be incarcerated at some time during adolescence, give birth as a teenager, and face unemployment as a young adult.
We need to cut the nonsense and put an end to Teenage Pregnancies.

Is a 16-year old young woman old enough to make decisions regarding her body?
Should Plan B be accessible to all women?

What "realistic" measures can we take to curb teenage pregnancies?
Would you be ok with your 16-year old daughter having access to Plan B over the counter?
Did Kathleen Sebelius overstep her authority by blocking the FDA's decision?
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