Federal Court Rules FDA Must Reconsider Plan ...(or whom the barriers and the benefits ar...),Health

The Court found that the FDA "acted in bad faith and in response to political pressure," "departed in significant ways from the agency's normal procedures," and engaged in "repeated and unreasonable delays." In addition, the court found that the FDA's justification for denying over-the-counter access to 17 year olds "lacks all credibility," and was based on "fanciful and wholly unsubstantiated 'enforcement' concerns."

Before its action on Plan B, the FDA had never restricted a non-prescription drug based on a person's 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.

Other evidence uncovered during the lawsuit showed that the agency repeatedly departed from its own established procedures during the FDA case, from filling the reproductive health committee with political "operatives" to making a decision to reject over-the-counter access to Plan B before completion of the standard review.

The Center's battle to make Plan B available over-the-counter to women of all ages began in 2001, when it filed a citizens' petition with the FDA on behalf of over 70 medical and public health organizations to grant the drug over-the-counter status. On January 21, 2005, the Center filed Tummino v. von Eschenbach in the U.S. District Court for the Eastern District of New York on behalf of the Association of Reproductive Health Professionals (ARHP); National Latina In
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