Medical Devices and Prescription Drug Policy

Judge slams FDA’s ‘frivolous’ defense of age limits on Plan B

A federal judge on Friday criticized the Obama administration for a “frivolous” effort to defend age restrictions on the birth-control pill known as Plan B.

Judge Edward Korman denied the Food and Drug Administration’s (FDA) attempt to delay a ruling that made Plan B available without a prescription to women of all ages. 

He gave the agency until Monday to seek a stay from an appeals court, denying its request for a stay while the case works its way through appeals.

{mosads}The FDA’s appeal “is frivolous and is taken for the purpose of delay,” Korman wrote, saying he would agree to give the agency the weekend to appeal as a courtesy to the appeals court.

As he has done repeatedly throughout the Plan B case, Korman sharply criticized Health and Human Services Secretary Kathleen Sebelius, calling the agency’s appeal “something out of an alternate universe.”

The FDA last year sought to eliminate all age restrictions on Plan B, which was then available without a prescription only to women 17 and older. Sebelius overruled the FDA’s scientists to leave the age restrictions in place.

Korman called it “a decision that was politically motivated and that, even without regard to the Secretary’s motives, was so unpersuasive as to call into question her good faith.”

He ruled last month that all age restrictions must be lifted for Plan B. Separately, the FDA dropped the age restriction from 17 to 15 — a move Korman found inadequate and still lacking a scientific foundation.

Tags Kathleen Sebelius
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