FDA Violated Law by Restricting Over-the-Counter Sales of Plan B, District Court Rules

Decision Underscores Need for Reform at FDA

March 23, 2009 -- A federal district court today ruled the Food and Drug Administration (FDA) violated its own rules when it restricted over-the-counter sales of the emergency contraceptive Plan B to women over 18. The New York City-based court ordered the FDA to reconsider its decisions regarding over-the-counter access and age restrictions and to extend over-the-counter access to 17 year olds within 30 days.

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The FDA maintained it restricted Plan B due to concerns about the drug's effect on adolescent girls, even though the agency's staff and two independent scientific advisory panels recommended that the agency approve the drug for over-the-counter sales for all ages. Numerous FDA officials and agency medical advisers called the agency's actions an extraordinary repudiation of government scientific expertise.

In today's decision, District Judge Edward R. Korman wrote that FDA rejected the Plan B application "despite nearly uniform agreement among FDA scientific review staff that women of all ages could use Plan B without a prescription safely and effectively."

"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...[FDA] departed in significant ways from the agency's normal procedures," he continued. "The FDA's justification for this age restriction, that pharmacists would be unable to enforce the prescription requirement if the cutoff were age 17, rather than 18, lacks all credibility."

The court decision underscores need for significant reform at the FDA, according to the Union of Concerned Scientists (UCS).

"When the courts need to step in to strike down decisions that are not based on science, we know that the FDA has a big problem," said Francesca Grifo, director of UCS's Scientific Integrity Program. "Our safety depends on the ability of new FDA leadership to make robust science the cornerstone of a sound and transparent drug approval process.

"The FDA's role should not be that of moral arbiter, but a source of science to protect the public good," Grifo added. "Today's court decision puts the FDA on notice that it needs to clean up its act. Once confirmed, the new FDA commissioner should send a clear signal to agency staff that decisions will be based on science, not politics."

Source: The Union of Concerned Scientists