No Better Time for Plan B

I have a package of Potassium Iodide tablets in my Go Bag, and I’m happy most days not to think about either, but I feel better knowing that they’re there. For those of you unfamiliar with either, or both–Potassium Iodide protects the thyroid from radiation poisoning, and a Go Bag is an emergency preparedness kit with enough supplies for a person to survive without outside help for at least three days.

If you didn’t know, consider yourself lucky. Or blissfully ignorant. I suppose it’s all a matter of perspective. That–and what the future happens to bring to yours.

Me, I decided back in the days of the dirty bomb scares that I’d rather have a package of ominously-packaged pills in the house than to one day wish I had bought some as an invisible deadly force fried my body. Same goes for the Go Bag. I put the pills in the bag, put the bag behind the couch, and honestly, including today, I can count on one hand the number of times I’ve thought about either in the past ten years.

Isn’t that how worst case scenario preparation should work? Prepare for the worst, hope for the best, and try not to scare the bejesus out of yourself in the meantime. Anything less would be irresponsible when it’s a matter of life and death, right?

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Obama Administration Overrules FDA, Won’t Ease Restrictions on Plan B

Earlier today, the Obama administration overruled a decision by the FDA to allow teenage girls to purchase Plan B without a prescription. Even though FDA Administrator Margaret Hamburg said in a statement that the pill could be used safely by girls and women, Kathleen Sebelius and the Health and Human Services Department apparently felt otherwise. According to Hamburg:

“[T]his morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential.”

For her part, Secretary Sebelius states that:

“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. … The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use.”

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FDA Must Lift Restrictions on Emergency Contraception

Since 2001, the FDA has dicked around with Emergency Contraception (EC), placing baseless restrictions on who can obtain it. But it looks like the walls are closing in on the FDA.

Although EC has been available — behind pharmacy counters with proof of ID — to those 18+ since 2006 and to those 17+ since 2009, it remains inaccessible for many. For example, women must approach the pharmacist and request EC; should the pharmacist’s religious beliefs conflict with providing Plan B, s/he may refuse to hand it over, under the protection of conscience clauses. And let’s not forget those under 17 who will be flat-out denied, and those (of any age) who simply can’t afford its high cost.

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Why is the FDA Stalling Plan B Access?

Today’s guest post comes to us from Ian Vandewalker, a Legal Fellow with the U.S. Legal Program at the Center for Reproductive Rights. Be sure to click on the link at the end of the post to take action and urge the FDA to approve Plan B for over-the-counter distribution.

Teva, the company that makes the morning-after pill Plan B One-Step, recently submitted an application to the FDA to make the drug available over-the-counter for women of all ages. Sound like a good thing? Well, it is and it isn’t.

Certainly any efforts to bring Plan B out from behind pharmacy counters and onto drugstore shelves – so women of all ages can purchase it – is positive, but the problem is… the FDA should have made emergency contraception fully available over the counter a long time ago.

Here’s some background explaining why, and why you should care:

The FDA’s been playing games with Plan B for almost a decade
Let’s not forget the Plan B-FDA saga started back in 2001 when the Center for Reproductive Rights filed a Citizen Petition with the FDA on behalf of over 70 medical and public health organizations to make Plan B available over-the-counter. In 2003, the drug’s manufacturers filed their own application for over-the-counter status. But the FDA, under the Bush administration, proceeded to drag out making a decision for years. The agency employed numerous stall tactics from missing application deadlines to requesting public comments. It wasn’t until the Center for Reproductive Rights filed a case against the FDA in 2005 for failing to make a decision, that the agency finally made a move… sort of. In 2006, the agency agreed to make the drug available without a prescription – but only to women 18 and older, only behind pharmacy counters and only when a woman showed photo I.D. [Read more...]

Plan B–Change the FDA

It’s been years. Literally.

After two change elections, why is the FDA playing the same old games with women’s health?

On March 23, 2009, a federal court ordered the FDA to make the emergency contraception drug Plan B available to women 17 and older without a prescription. It is ludicrous—if not criminal, for the FDA to have ignored this order.

That’s why the Center for Reproductive Rights has filed a motion of contempt against the Food and Drug Administration. Maybe the FDA can be shamed into obeying the law. 

Maybe the FDA can be shamed into following its own experts’ advice. Remember, when President Obama came into office, he promised his administration would “ make scientific decisions based on facts, not ideology.” 

Well,  “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,” according to Suzanne Novak, lead counsel in the case. [Read more...]

FDA Advisory Panel Backs New Morning After Pill

An FDA advisory panel voted unanimously to to approve a new version of the “morning after pill.” The new form of emergency contraception, will be sold under the brand name of “ella,” and it can be taken up to 5 days after sexual intercourse.

Ella is already being used in Europe. The women who took ella (also know as UPA) in the clinical trials had a higher success rate than those who took the current FDA-approved option, Plan B. The emergency contraception that is currently available in the U.S. as an over-the-counter product, works most effectively in the first 3 days after unprotected intercourse by preventing ovulation. By comparison, ella has proven to be equally effective throughout the 5 days after unprotected intercourse.

Ella is not an abortion pill. UPA, like other forms of emergency, delays ovulation and will not cause an abortion. It’s important to remember that the medical definition of pregnancy is when a fertilized egg (sperm and egg) implants into the uterus. UPA prevents fertilization by suppressing ovulation.

As of today, ella will only be available by prescription. However, more studies are being conducted to prove ella’s effectiveness for over-the-counter distribution. The FDA’s final vote for approval will happen in July or August.

For more information about ella, check out this story from NPR.

FDA Approves the First Four-Phase Oral Contraceptive to Hit U.S. Markets

In the midst of the birth control pills 50th birthday, the FDA has officially approved a brand new birth control option for American women. The pill, Natazia, was officially given the stamp of approval by the U.S. Food and Drug Administration on Thursday. Looks like Natazia has the same risks with the potential for less menstrual bleeding. Moreover, Natazia combines the hormones estrogen and progestin in doses that adjust four-times throughout a woman’s cycle.

The pill, already licensed in Europe under the brand name Qlaira, is the first four-phase oral contraceptive marketed in the United States, the FDA said.

It delivers varying doses of the hormones progestin at four times throughout each 28-day treatment cycle. [Read more...]

The Pill Turns 50

In June, 1960 the Food and Drug Administration (FDA) approved the first birth control pill for use in the United States. The birth control pill as a method of contraceptive has been around for fifty years now and over 12 million women in the United States use the pill as their preferred method of planned parenthood. In short, the approval of the birth control pill by the FDA signaled an incredible shift in the women’s movement. Prior to the advent of the pill, reproductive rights was a discussion largely omitted in the discourse surrounding women’s rights in the United States. Women’s rights activists such as Emma Goldman and Margaret Sanger, to name a few, brought this issue to the forefront by becoming public advocates for birth control.

At the turn of the twentieth century, women began to demand sexual freedom for themselves; the freedom to enjoy sex without worrying about pregnancy, plan the size of their family, and make their own decisions about their bodies. So, the FDA may have given the green light to birth control, but it was the women who fought for autonomy and self-determination that ushered in an era of birth control and other contraceptives. Check out this fascinating look at the history and controversy of the pill in the latest issue of Time. [Read more...]

Aphrodisiacs: Real or Money-Making Scheme?

chocolate and roses

Hi Steph! Do aphrodisiacs actually work? What are the best ones?

I have to admit I’m with you on the skepticism. The existence of magic potions and foods that make sex more enjoyable seems more like the stuff of Greek myth than reality. Turns out I wasn’t far off in my prediction – the word “aphrodisiac” comes from the name of the Greek goddess of love, beauty, and sexuality, Aphrodite.

According to National Geographic, people have ben obsessed with sex stimulant boosters basically forever. While you’d think that would mean a lot of research has gone into the topic, in fact the opposite is true. The Kinsey Institute for Research in Sex, Gender, and Reproduction reports (in a book from 1990) that no aphrodisiacs have ever been scientifically proven to increase sexual arousal or enjoyment. The folks at the Kinsey Institute caution against products that state that they have been endorsed by doctors or that they perform some kind of miracle, as these products are more likely to be dangerous and a complete waste of your money. If there ever is a legitimate product that helps increase sexual arousal, it should have the names of doctors, hospitals, and research studies attached to it so you can look at the studies yourself in a library. It will also list the ingredients so you can consult with a pharmacologist before taking it. Any product without a traceable research past should be treated as suspicious. Apparently people are so crazy about this shit that the FDA has even come out against it, saying, “There is no scientific proof that any over-the-counter aphrodisiacs work to treat sexual dysfunction,” despite that this decree “clash[es] with a 5,000-year tradition of pursuing sexual betterment through use of plants, drugs and magic.” [Read more...]

Is Yaz Safe?

yazSwissmedic, the Swiss agency that is responsible for overseeing the safety of medications, is currently investigating the safety of the birth control method Yaz. The investigation was launched after a woman died from a pulmonary embolism that is believed to have been caused from taking Yaz.

The Swiss investigation comes at the same time as 74 different lawsuits that have been filed in the United States against Bayer Healthcare, the company that manufactures Yaz. According to the National Partnership for Women & Families:

These groups argue that the drugs put women at higher risk for strokes, blood clots and other health problems than some other oral contraceptives. Citing warning letters FDA sent to the company, plaintiffs’ attorneys contend that Bayer was aware or should have been aware of the problems. These new concerns could “rattle consumer confidence” and harm the drugs’ image as the “go-to brands for women under 35,” according to some industry analysts, the Times reports.

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