Kathleen Sebelius is the first health secretary to overrule the FDA, according to an agency spokeswoman.
For the time being, females 16 and under concerned about pregnancy can kiss unrestrained access to the morning-after pill goodbye. On Wednesday, Health and Human Services Secretary Kathleen Sebelius overruled the FDA’s decision that emergency contraceptives be made freely available to youths over the counter.
Her justification? Eleven-year-old girls were not included in the trials that determined the drug was safe for everyone. A New York Times report did not say whether there is any reason to suspect the drug known as Plan B posed harm to adolescent females of any age. —ARK
The New York Times:
After reviewing the scientists’ determination, Dr. Hamburg [commissioner of the drug administration] wrote that she agreed “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.”
But on Wednesday morning, Ms. Sebelius sent Dr. Hamburg a note saying that she did not agree, so the agency was rejecting the application for the change.
In a statement, Ms. Sebelius said that the drug’s manufacturer had failed to study whether girls as young as 11 years old could use Plan B safely. And since about 10 percent of girls are capable of bearing children as early as 11, those girls need to be studied as well, she wrote.