Fourteen U.S. Senate Democrats have sent a letter to Health and Human Services Secretary Kathleen Sebelius asking for the “scientific rationale” behind her decision to reverse an FDA request to expand access to over-the-counter emergency contraception for teenagers under the age of 17.
In a statement announcing her decision, Sebelius said that although “the science has confirmed the drug to be safe and effective with appropriate use, 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.
Reproductive rights advocates immediately denounced the decision. Numerous groups have already released statements and written letters to Sebelius and the White House expressing disagreement with the decision.
The Washington Post reports that now a group of U.S. senators have written a letter to Sebelius requesting an explanation.
According to the letter:
We feel strongly that FDA regulations should be based on science. We write to you today to ask that you provide us with the rationale for this decision.
As numerous medical societies and patient advocates have argued, improved access to birth control, including emergency contraception, has been proven to reduce unintended pregnancies. Nearly half of all pregnancies that occur in the United States each year are unintended. Keeping Plan B behind the counter makes it harder for all women to obtain a safe and effective product they may need to prevent an unintended pregnancy.
We ask that you share with us your specific rationale and the scientific data you relied on for the decision to overrule the FDA recommendation. On behalf of the millions of women we represent, we want to be assured that this and future decisions affecting women’s health will be based on medical and scientific evidence.
President Obama has publicly supported Sebelius’ decision.