Health and Human Services shoots down over-the-counter morning-after pill for teens
WASHINGTON, D.C., December 7, 2011 (LifeSiteNews.com) - The Federal Health and Human Services Department (HHS) has overruled the FDA, nixing plans to allow minors access to the morning-after pill without a prescription.
The move by HHS Secretary Kathleen Sebelius came as a surprise, controverting the advice of her own experts.
The FDA, which had lowered the minimum age of girls accessing Plan B over-the-counter to 17 in April 2009, was poised to make a decision Wednesday to make the drug available to girls of any age. FDA Administrator Margaret Hamburg in a statement said she had decided the drug was safe for young girls, but that the decision had been overruled by Sebelius.
Hamburg said she had concluded that “there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.”
However, she added, “this 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.”
In a memorandum explaining her decision, Sebelius expressed concern that the “label comprehension and actual use studies submitted to FDA do not include data on all ages for which the drug would be approved and available over-the-counter.”
“Yet,” she continues, “it is commonly understood that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age, which I believe are relevant to making this determination as to the non-prescription availability of this product for all ages.”
Popular pro-life writer Jill Stanek called the decision by the pro-abortion Sebelius “a shocking dose of sanity.”
The morning after pill drug, sold under the brand name Plan B, acts both by preventing fertilization and by thinning the lining of the uterus, which can lead to the death of a new embryo. Family planning lobbyists had urged the government to make the pill as accessible as possible.
“Hopefully, it will be right on the shelves between the condoms and the pregnancy tests,” Kirsten Moore of the Reproductive Health Technologies Project, had said.
Some pro-life leaders suspect that the move by Sebelius, whose record both as Kansas governor and HHS Secretary has staunchly favored the family planning industry, may have been politically calculated. The administration shocked U.S. bishops and other Catholic leaders this summer by announcing plans to force nearly all private insurers to cover even abortifacient birth control such as Plan B without co-pay, including many church-run organizations.
Human Life International President Father Shenan J. Boquet said the Plan B decision was “welcome,” but that his group remained “very concerned” about the impending birth control mandate.
“If this decision by Secretary Sebelius is truly about protecting the health of young women, then she will reconsider the HHS rule forcing private insurers and employers to pay for services to which they are diametrically opposed,” said Boquet.
“But, if this move is intended as a pragmatic one to alleviate concerns of those, such as the Catholic bishops, who are rightly concerned with her department’s activist promotion of contraception, then it will fail in its objective. The mandate must be reversed, and soon.”