Health Secretary Rejects Plan to Increase Availability of Emergency Contraception
SOURCE:
Health and Human Services Secretary Kathleen Sebelius has overruled the FDA’s decision to allow Plan B to be sold over-the-counter and to women under 17.
Women will not be able to purchase emergency contraceptives over the counter, and the drugs will not be available to women under 17, Health and Human Services Secretary Kathleen Sebelius has decided.
In an unprecedented move, Sebelius overruled the FDA’s decision on Wednesday, stating that Plan B One Step will not be available over-the-counter in drugstores, a proposal that originally would have made the drug available to women 16 and under.
Though deemed as safe, effective, and teen-friendly by the Food and Drug Administration, Sebelius’ move marked the first time a health secretary has overruled the FDA, according to the New York Times.
In a statement Wednesday, FDA Commissioner Margaret Hamburg said:
I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER, and I agree with the Center 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, 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. Because of her disagreement with FDA’s determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved.
While the ruling is not technically a setback for women’s reproductive rights—essentially, everything stays the same— it keeps in place a host of barriers for women of all ages.
In order to be effective, the pill must be taken within 72 hours of intercourse, making it difficult for women under 17, who must continue to receive a prescription. (It’s certainly a challenge, factoring in the time is takes to schedule a doctor’s visit, attend the appointment, and travel and delaying access to the pill.
Women 17 and older won’t need a prescription for Plan B, but still must show proof of age and then, in some cases, deal with a pharmacist who regards their birth control choices with disdain.
Sebelius also released a statement on Wednesday, explaining her split with the FDA. She citied data provided by Plan B manufacturer Teva Women’s Health Inc., saying it did not “conclusively establish” that the drug, which contains levonorgestrel, could be safely used by girls of all ages:
“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,” Sebelius wrote.
She noted that girls in the United States, on average, experience the onset of menstruation at 12.4 years, though about 1 in 10 girls is physically capable of becoming pregnant by the time she is 11.
“It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age,” Sebelius wrote. “If the application were approved, the product would be available, without prescription, for all girls of reproductive age.”
During her political career, Sebelius has defended reproductive rights for women, despite being personally opposed to abortion.
Naima Ramos-Chapman is an associate editor at Campus Progress.
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