BROOKLYN, N.Y. (CN) – In a strongly worded opinion, a federal judge in Brooklyn ordered the Food and Drug Administration to make the Plan B “morning-after” birth-control pill available without a prescription to women as young as 17. U.S. District Judge Edward R. Korman chided the government for ignoring scientific evidence when setting the age restriction at 18 and for “repeatedly and unreasonably” delaying decision-making on the controversial pill for “suspect reasons,” including political considerations.
A coalition of Plan B advocates, including parents of minors seeking access to drug, originally petitioned the FDA to make the birth-control pills available without a prescription or age restriction, as they are in most industrialized nations.
When the FDA denied unfettered access, Plan B sponsors asked the agency to make it available to women 16 and older.
“The FDA rejected that application, too, despite nearly uniform agreement among FDA scientific review staff that women of all ages could use Plan B without a prescription safely and effectively.”
The petitioners submitted a third proposal boosting the age to 17, but the FDA insisted on 18, citing “enforcement concerns.”
The citizen petitioners and companies that had submitted supplemental new drug applications challenged the decision as arbitrary and capricious, saying it was grounded in reasoned and good faith agency decision-making.
“Plaintiffs are right,” Korman wrote. He said the agency was slow to act, and only did so to facilitate the confirmation of acting FDA commissioners.
“These political considerations, delays, and implausible justifications for decision-making are not the only evidence of a lack of good faith and reasoned agency decision-making,” Korman added. “Indeed, the record is clear that the FDA’s course of conduct regarding Plan B departed in significant ways from the agency’s normal procedures regarding similar applications to switch a drug product from prescription to non-prescription use.”
The judge concluded that the drug should be available over the counter for 17-year-olds.
“The FDA has simply offered no evidence that the age restriction would be unenforceable at 17 rather than 18,” he concluded.