Last week, about a controversial decision by HHS Secretary Kathleen Sebelius, who overruled the FDA’s decision that emergency contraception should be made available over the counter to women of all ages.
On Friday, former FDA official Susan Wood issued her response to the move in the , rejecting Sebelius’s claim that read data is needed on safety and label comprehension for the youngest of possible emergency contraception users:
…this type of age restriction, and worries about the use of medicines by teenagers, have not been applied to other products…Indeed, for no other over-the-counter medication has the FDA ever required extra data for a particular age group. (This extra data on younger teenagers was provided to the FDA in the latest application by the company.)
But somehow, the prescription requirement for Plan B — which is very safe and impossible to overdose on — remains in place for those younger teens who are in the unfortunate situation of being at risk of pregnancy and who need emergency contraception immediately.
Wood also notes that because the age restriction remains, access for older women remains restricted – emergency contraception is available without a prescription for those over 17, but is still behind a pharmacy counter.
Wood previously served as assistant FDA commissioner for women’s health and director of the Office of Women’s Health. She resigned in 2005 because of past politically motivated delays in emergency contraception approval, :
I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled.
Now, Wood calls out Obama for breaking his promise to the American people by allowing this overruling:
In his scientific integrity memo, the president stated: “When scientific or technological information is considered in policy decisions, the information should be subject to well-established scientific processes, including peer review where appropriate, and each agency should appropriately and accurately reflect that information in complying with and applying relevant statutory standards.”
In overturning the well-considered, scientifically based decision of the FDA, Sebelius and the Department of Health and Human Services certainly did not “appropriately and accurately reflect” the available scientific information…The president should stand by the principles of scientific integrity and restore science to its rightful place. He should support the FDA commissioner and direct the secretary to allow the agency to do its job. By doing so he will fulfill the promise of that beautiful day in March 2009 when he pledged that science would trump politics, not the other way around.
If you would like to write President Obama to object to Sebelius’s action and remind him to remember his promise about scientific integrity, you can the White House directly via .