Teva Pharmaceuticals, the manufacturer of Plan B (the “morning after pill”), submitted a request to the FDA to make the pills available over the counter (OTC) without any age restrictions. That would effectively have paved the way for emergency contraceptives to be sold on store shelves, instead of from behind the pharmacy counter. Today, as expected, FDA scientists recommended that Teva Pharmaceuticals’ request be approved. However, Health Secretary Kathleen Sebelius overruled their recommendation and declined to remove the restrictions.
History of Plan B and the FDA
In 2003, the FDA went against a committee recommendation to make the drug available OTC. According to Jessica Valenti, “they were worried about young women getting all slutty”. She also quoted one of the FDA committee members who said: “What we heard today was frequently about individuals who did not want to take responsibility for their actions and wanted a medication to relieve those consequences.”
Eventually, in 2006, the FDA agreed to make Plan B available without a prescription, but age restrictions on access to it (only for those 17 or over) effectively meant that women had to talk to a pharmacist to get it and that those under 17 had to see a doctor to get a prescription first.
Today’s Overruled Recommendation
This year, Teva Pharmaceuticals applied to have the age restrictions removed, which would have allowed Plan B to be sold on drugstore shelves, right between the condoms and the pregnancy tests. Today, FDA Commissioner Margaret Hamburg, M.D. released a statement noting that teenage girls were able to use Plan B effectively without help. She wrote:
The Center for Drug Evaluation and Research (CDER) completed its review of the Plan B One-Step application and laid out its scientific determination. CDER carefully considered whether younger females were able to understand how to use Plan B One-Step. Based on the information submitted to the agency, CDER determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.
In conclusion, she said:
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, Dr. Hamburg then noted that she received a memorandum from Secretary Sebelius indicating that she did not agree with the Agency’s decision and that she was invoking her authority to block the approval.
Photo credit: meddygarnet on flickr
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