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Earn Free CME Credits by reading the latest medical news in your specialty.Sign UpThe federal judge who ordered the FDA to make the emergency contraceptive Plan B One-Step (levonorgestrel) available over the counter to women of all ages on Wednesday approved the agency's plan to comply with that order.
However, some women's rights advocates objected to the FDA's plan, saying it didn't go far enough.
But Judge Edward Korman of the U.S. District Court for the Eastern District of New York called the FDA's plan "sufficient."
After a legal and political battle over the issue, the FDA late Monday told Korman it would comply with his order to allow sales of the one-pill emergency contraceptive without age restrictions or other access limitations.
The agency will, however, continue to restrict OTC sales of the two-pill version, called simply Plan B, to those 17 and up. The FDA said there are fewer data available testing how well young girls understand and follow the instructions of the two-pill Plan B.
Attorneys representing the group who sued the FDA to remove age restrictions on the OTC emergency contraceptive told the judge Wednesday the FDA plan should have included the two-pill Plan B and other emergency contraceptives. Furthermore, the FDA didn't provide details on when it would meet the judge's order.
"More than 12 years have passed since the Citizen Petition was filed," they wrote. "Women and girls have waited long enough for the government to remove the unscientific and politically motivated barriers to emergency contraception."
Korman rejected those thoughts.
"My order ... is clear that the defendants may limit over-the-counter approval to the one-pill product if they 'actually believe' that any such difference exists," the judge wrote. "On the assumption that the Commissioner of Food and Drugs entertains the good-faith belief that the products should be treated differently, the defendants' proposal is sufficient to comply with my order."
The plaintiffs told the judge that without more alternatives to Plan B One-Step, costs would be a barrier to access for buyers.
"Nevertheless, 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," Korman wrote. "The real problem relating to cost deals with the potential period of marketing exclusivity that the FDA may grant to Teva."
The FDA late Monday told a federal judge in New York City it would comply with its order to allow sales of the one-pill emergency contraceptive Plan B One-Step without age restrictions or other access limitations. The agency will, however, continue to restrict OTC sales of the two-pill version, called simply Plan B, to those 17 and up.
Korman ruled on April 5 that the FDA had to make available levonorgestrel-based emergency contraceptives without a prescription -- and without point-of-sale or age restrictions -- within 30 days. Later that month, the FDA approved a supplemental application by sponsor Teva Women's Health to make the Plan B One-Step OTC to consumers ages 15 and up, but stopped short of making it available to all ages.
The Justice Department wrote Korman late Monday to say it would drop its appeal of his April 5 ruling following an appeals court stay of that ruling.
Plan B One-Step and Plan B both were previously available over the counter only to women 17 and older; those younger needed a prescription. Reproductive rights advocates said making the contraceptive available only with a prescription limited access for younger patients in need.
David Pittman
David Pittman is MedPage Today’s Washington Correspondent, following the intersection of policy and healthcare. He covers Congress, FDA, and other health agencies in Washington, as well as major healthcare events. David holds bachelors’ degrees in journalism and chemistry from the University of Georgia and previously worked at the Amarillo Globe-News in Texas, Chemical & Engineering News and most recently FDAnews.
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