FDA Ordered to Make Decisions Based on Science, Not Ideology

Washington, DC (March 23, 2009) -- Today, the U.S. District Court for the Eastern District of New York ruled that the Food and Drug Administration (FDA) decision to restrict over-the-counter access to Plan B (the dedicated emergency contraceptive product) based on age was “arbitrary and capricious” and violated the agency’s “reasoned and good faith decision-making.” The court ordered the FDA to extend over-the-counter access to Plan B to 17 year olds within 30 days and to reconsider making it available without a prescription for those younger.

“The court has sent the FDA a clear and unambiguous message,” said Debra Hauser, executive vice president of Advocates for Youth. “Any decision that impacts the health and well-being of young women must be based on medical science and sound reasoning.  Leave politics and ideology at the door.”

In 2005, the Center for Reproductive Rights sued the FDA for going against the advice of scientific experts in failing to grant over-the-counter status to Plan B (emergency contraception).  After the FDA agreed to make Plan B available without a prescription only to women 18 and older in 2006, the Center continued its legal challenge.

“By sending this case back to the FDA, the court recognized the political nature of the earlier decision,” added Hauser. “The FDA has one more opportunity to put the health of women in the forefront and ensure that science, not ideology, dictates all future decisions.”

According to a press release by the Center for Reproductive Rights - -

“Before its action on Plan B, the FDA had never restricted a non-prescription drug based on age, nor had the Bush Administration ever been consulted by the FDA about an over-the-counter drug application. Depositions of senior FDA officials by the Center in 2006 indicated that the Bush Administration sought to unduly influence the agency during the Plan B application review process.  Testimony also indicated that officials involved in the decision-making process were concerned about losing their jobs if they did not follow the Administration’s political directives.”