Colorado U.S. Rep. Diana DeGette, head of the pro-choice caucus and a staunch advocate for women’s health rights, said she was disappointed that the Obama Administration Secretary of Health and Human Services, Kathleen Sebelius, on Wednesday opposed a recommendation by the Food and Drug Administration, announcing she would deny a request to expand access to over-the-counter emergency contraception to women under 17.
“I have always been committed to ensuring all our health policy decisions are grounded in sound science. The FDA’s review process was clearly extensive and thorough, and the data shared with HHS made clear that Plan B is safe and effective for its intended use,” DeGette wrote in a release. “Access to reliable and safe contraception is a fundamental component of health care and bringing Plan B from behind the pharmacy counter onto the shelves with other contraceptive methods would have been a victory for women’s health.”
DeGette looked forward to expanding access to the drug as a great victory for women’s health care and Sebelius’s move clearly came as a surprise.
Writing at the Huffington Post this week in anticipation of the decision, DeGette said expanding access to the Plan B pill to high school girls would be a great victory for women’s health.
If they approve this move, as we hope they will, it would be a great victory for women’s health care; when a woman can plan how and when she wants to have her family, there are proven health, economic and social benefits to her, her family, and indeed our society overall…
If the FDA approves this step, it will reflect the proven science of an important contraceptive innovation for American women. Access to reliable and safe contraception is a fundamental component of basic health care.
DeGette noted that, as with so much related to women’s reproductive health, the topic of the “morning after pill” was fraught. She warned against bad information.
directly in conflict with that science, many ideologues are once again trying to stand in the way of this advancement for women’s health care…
To be clear — emergency contraception is not a so-called “abortion pill.” Much like the traditional birth-control pill, Plan B One-step works to prevent fertilization, and therefore, pregnancy. Despite false declarations from extreme opponents, Plan B One-step does not work if the woman is already pregnant.
The Plan B pill is currently available without a prescription to any woman 17 or older with a photo ID. Reproductive rights advocates have long warned that this type of age restriction creates ill-advised longer wait times for young women seeking emergency contraception.
Teva Pharmaceuticals had applied to make its pill the first over-the-counter form of emergency contraception.
Secretary Sebelius explained that she thought that women as young as 11 might seek out the pill and she was unsure such young women could use the pill properly.
Although “the science has confirmed the drug to be safe and effective with appropriate use,” she said, “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,” she said in a statement today.
According to her statement:
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 surprise move by a member of the pro-choice Obama administration had many analysts suggesting the rejection of the FDA recommendation should be seen as political maneuvering. They said the White House might be trading access to the morning after pill for conservative support for initiatives it considers more pressing, initiatives likely tied to relieving the economic pressure of the recession.
If there’s any truth to such speculation and if the health care reform debate is any measure, analysts point to the need to win over conservative Democrats on matters related to abortion for an extension of unemployment benefits, for example.
John Tomasic contributed to this report.