In 2011, the Health and Human Services secretary overruled the FDA on its determination that there should be no age restrictions on buying morning-after pills. Now Justice is saying that FDA should be setting the rules, not a federal judge.
Teva Women's Health/AP
The Justice Department’s decision to appeal a federal judge’s order removing age restrictions on buying morning-after pills keeps the politically charged issue of emergency contraception in the spotlight.
The decision, announced Wednesday night, does not affect the Food and Drug Administration’s rule announced Tuesday that lowers the age limit on the purchase of the most widely known morning-after pill by people as young as 15 without prescription.
The new age limit on Plan B One-Step, down from 17, goes into effect immediately.
In federal court, the debate centers on who determines the rules regarding availability of a medication, including whether there should be any age limit at all. In a letter to District Judge Edward Korman of New York, US Attorney Loretta Lynch said he had overstepped his authority.
“The public properly relies upon FDA classification of drugs as nonprescription as a reflection of the agency’s judgment regarding the safety and proper use of a drug without a doctor’s prescription,” Ms. Lynch wrote, according to USA Today. “The public interest will not be served by reclassification of drugs as nonprescription by order of a court, without appropriate agency decisionmaking procedures being followed.”
The irony in her statement is that the FDA had determined in 2011 that age restrictions on availability of the morning-after pill were unnecessary, based on scientific research – a conclusion cited by Judge Korman in his April 5 ruling. But in December 2011, Health and Human Services Secretary Kathleen Sebelius overruled the agency and barred the drug’s sale to girls under age 17, citing a lack of evidence it was safe. On Tuesday, the FDA announced that it had approved over-the-counter sale of one type of pill, Plan B One-Step, to people aged 15 and older.