June 12, 2013 - The long-running lawsuit over emergency contraception
finally ended Wednesday evening when a federal judge granted the Obama
administration’s proposal to make the best-known morning-after
pill available to all ages without a prescription.
Judge Edward R. Korman of the
Eastern District Court of New York ruled that the government’s plan to make
Plan B One-Step and its generic versions available over the counter was
sufficient to comply with his order that the Food and
Drug Administration remove all sales and age restrictions for these drugs.
Earlier on Wednesday, plaintiffs in the case,
represented by the Center for Reproductive Rights, asked Judge
Korman to reject the government’s proposal because it did not include the
two-pill versions of the drug. Although two-pill versions are fast being
replaced by one-pill versions, the plaintiffs noted that they were cheaper and
that scientists had found no significant difference between them.
But the judge wrote that his original order in April
said the F.D.A. could keep restrictions on two-pill versions if it “actually
believed there was a significant difference.” The F.D.A. has said there are not
enough studies to show that young women can responsibly take two separate doses
instead of just one.
Judge Korman wrote that though two-pill versions can
still be restricted “because off-brand versions of the one-pill product are
available, it is at best speculative whether the two-pill product will provide
a significantly cheaper alternative.”
He strongly urged the government not to give Plan B One-Step’s maker, Teva Pharmaceuticals, market exclusivity, which could affect the availability and cost of generic versions. “Marketing exclusivity will only burden poor women,” he wrote, adding, “It is the plaintiffs, rather than Teva, who are responsible for the outcome of this case, and it is they, and the women who benefited from their efforts, who deserve to be rewarded.”