Michael Winter, USA TODAY
The Justice Department said late Wednesday that it is appealing a U.S. judge's order that lifted all age limits on buying the Plan B "morning-after" birth control pill without a prescription.
The appeal, along with a request for an injunction, would not affect the Food and Drug Administration's decision Tuesday to allow the emergency contraceptive to be sold without a prescription to women and girls at least 15 years old.
In a letter to District Judge Edward Korman of New York, the U.S. Attorney Loretta Lynch told the judge that he had exceeded his authority and that the Second Circuit Court of Appeals had been asked to suspend his April 5 ruling.
Korman had given the FDA until May 5 to lift all age limits on Plan B and a cheaper generic, made by Israel-based Teva Pharmaceutical Industries. He ordered that the emergency contraceptives should be sold over the counter, like aspirin.
A code on the package will prompt a cashier to verify a customer's age.
On Tuesday, the FDA announced its policy change on over-the-counter sales of Teva's Plan B One-Step. The agency was ready to lift age restrictions in 2011, but Health and Human Services Secretary Kathleen Sebelius intervened and set the age limit at 17. She subsequently supported lowering the age to 15.
The FDA said Tuesday that its action was "independent" of Korman's order and "not intended to address it," a position Lynch reiterated in her letter to Korman.
Plan B One-Step, which contains a hormone found in birth control pills, neither terminates a pregnancy and nor harms a developing fetus, the FDA said.
"The public properly relies upon FDA classification of drugs as non-prescription as a reflection of the agency's judgment regarding the safety and proper use of a drug without a doctor's prescription," she wrote. "The public interest will not be served by reclassification of drugs as non-prescription by order of a court, without appropriate agency decision-making procedures being followed."
She explained why the Obama administration asked for an injunction:
A stay of the Court's order will prevent public uncertainty regarding the status of the drugs at issue here pending the government's appeal to the Second Circuit. Moreover, if the status of these drugs is changed and later reversed, it can lead to situations in which women mistakenly believe that they can obtain the drug without a prescription or at certain locations where it used to be, but is no longer, available. Depending on the outcome of the appeal, the problem would be exacerbated because products with incorrect labeling will presumably remain on pharmacy shelves even after an appellate ruling reversing the injunction.
In his opinion last month, Korman said the "FDA has engaged in intolerable delays" over a dozen years that amounted an "administration agency filibuster."
Last week, in an interview with USA TODAY's Editorial Board, FDA Commissioner Margaret Hamburg said the agency had not decided how it would respond to the judge's order.
The pill works in one of three ways: It may prevent or delay ovulation; interfere with fertilization of an egg; or prevent a fertilized eggs from being implanted in the uterus by altering the lining.
Studies show that about half of all pregnancies are unintended.
In the agency's statement Tuesday, Hamburg noted, "Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the U.S."
Planned Parenthood called the FDA's action "an important step forward."
Responding to the administration's appeal, the organization's president, Cecile Richards, said that "we continue to believe that access should be expanded further. ... Age barriers to emergency contraception are not supported by science, and they should be eliminated."
In contrast, the anti-abortion group Susan B. Anthony List said it supported the appeal but opposed the FDA's action, which it claimed would "endanger the lives of teen girls."
"Whether they are 15 or 17, teens need the protection and support that comes with parental and doctor involvement," SBA List President and Chairwoman Marjorie Dannenfelser said in a statement. "Anyone who either has children or knows children, understands that they need their parents. The Administration is moving in the wrong direction if they seek to set an underage standard."