The Obama administration on Wednesday rebuffed a request by the Food and Drug Administration to ease restrictions of Plan B One-Step that would allow girls under 17 to purchase the emergency contraception directly from drug stores without a prescription.
In a statement released Wednesday afternoon, FDA Commissioner Margaret Hamburg, MD, said it is the agency’s responsibility to approve drugs that are safe and effective for their intended use based on the scientific evidence.
“[Agency] experts, including obstetrician/gynecologists and pediatricians, reviewed the totality of the data and agreed that it met the regulatory standard for a nonprescription drug and that Plan B One-Step should be approved for all females of child-bearing potential,” Hamburg said.
However, U.S. Department of Health and Human Services Secretary Kathleen Sebelius overruled FDA’s request and in a separate statement cited a lack of scientific evidence to support the eased restriction.
“The average age of the onset of menstruation for girls in the United States is 12.4 years. However, about 10 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,” said Sebelius.
The overruling came as a tremendous disappointment to reproductive health advocates and medical groups.
“This change would have made [emergency contraception] far more available to women of all ages — which on balance is a wise path — especially given that the vast majority of unplanned pregnancies and abortions in the United States are among women in their 20s and 30s.Simply put, I am particularly disappointed that the ruling today will prevent all women from getting emergency contraception with fewer hurdles to overcome,” said Sarah Brown, CEO of the National Campaign to Prevent Teen and Unwanted Pregnancy.
Karrie Galloway, president of Planned Parenthood of Utah said they are “…fighting politically. If the end goal is to rescue the need for abortion, which politically is a big debate in this country, why are we putting hurdles in peoples’ way for managing their reproductive health?”
“The decision to continue restricting access to this safe and effective product is medically inexplicable,” said Robert Block, MD, FAAP, president of the American Academy of Pediatrics. “The AAP strongly encourages the use of contraception—including EC—by adolescents who choose sexual activity, and recommends that teens receive appropriate counseling on EC use by a pediatrician or other primary care physician.”
“Today’s disappointing decision by HHS counters advancements in public health and welfare by minimizing young women’s ability to safely and responsibly control and protect their reproductive health,” said James N. Martin, Jr., MD, president of the American Congress of Obstetricians and Gynecology (The College).