FDA, at the behest of HHS, denies permission to sell Plan B in front of the counter
The FDA had been making plans to allow TEVA Pharmaceuticals to sell its Plan B contraceptive in front of the pharmacy counter to women of any age. But Health and Human Services Secretary Kathleen Sebelius intervened at the last minute to prevent it.
Kathleen Sebelius, the U.S. Health and Human Services secretary, has overruled the Food and Drug Administration and will not allow women younger than 17 to receive emergency contraceptive without a prescription.
Plan B, as the pill is known, had originally only been available via prescription. A few years ago, it became available over-the-counter to people 17 and older.
The FDA was moving to make it available on shelves of pharmacies, rather than from pharmacists, and available to people of any age. But Sebelius intervened at the last minute to reverse the FDA's plan.
"I reviewed and thoughtfully considered the data, clinical information, and analysis provided by (The Center for Drug Evaluation and Research), 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," FDA Administrator Margaret A. Hamburg said in a statement.
Sebelius said she acted because she was not confident in the data used by the center to determine the drug's safety for women of all ages.
"The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use," Sebelius said in a statement. "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."
Many doctors, women's health advocates and even members of Congress were surprised by the decision. As was TEVA, the drug manufacturer.
"We commend the FDA for making the recommendation ... and we are disappointed that at this late date, the Department of Health and Human Services has come to a different conclusion," said a statement Teva issued Wednesday, according to the Associated Press.
Others cried politics.
"We are outraged that this administration has let politics trump science," Kirsten Moore of the Reproductive Health Technologies Project said to the AP. "There is no rationale for this move."
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