"The government’s objection is completely meritless and reflects the wall of secrecy that the government has tried to erect in all of the White House activities."
Simon Heller, Staff Attorney for the Center, Lead Attorney for Tummino v. von Eschenbach
On January 21, 2005, the Center for Reproductive Rights filed a lawsuit against the Food and Drug Administration (FDA) in the U.S. District Court for the Eastern District of New York for its failure to make the emergency contraceptive Plan B available without a prescription to women of all ages. According to the suit, the FDA broke its own rules and regulations by allowing politics to trump science in its decision-making around Plan B. The agency ignored decades of scientific research proving that Plan B is safe and effective for all ages and its most important responsibility—to advance the public health.
On August 23, 2006, after years of foot-dragging and inexplicable delays, the FDA did announce a decision to increase women’s access to Plan B, but with a caveat: only women over 18 could get the drug without a prescription and the drug would still be placed behind pharmacy counters, requiring identification to receive it.
Despite this rule change, months of testimony from high-level FDA officials and discovery documents in the Center’s lawsuit still reveal a tangled web of deceit and obfuscation behind-the-scenes. Acting under outside political influences, agency officials made a compromise to circumvent regulations, ignore scientific experts, and delay any action on Plan B for as long as possible, then only grant limited access. The New York federal court has concluded on more than one occasion that there is a "strong showing of bad faith" on the part of the FDA. Consequently, the Center is still pursuing its case to ensure that Plan B is granted true over-the-counter status and made widely available to women of all ages—particularly the most vulnerable population—young women.
Read more about Plan B's Timeline here > >
In Recent News:
Center Files for Final Judgement in FDA Plan B Case
March 30, 2007 -- The Center has filed for summary judgement in its case against the Food and Drug Administration over the agency's handling of Plan B. We argue that the undisputed facts found in evidence gathered through discovery make it unnecessary for the court to hold a trial, and that the court should order the agency to make Plan B available without a prescription to women of all ages.
Our brief lays out evidence that demonstrates that the FDA acted unlawfully by ignoring scientific evidence and by singling out Plan B and holding it to a higher standard of approval than other over-the-counter drugs. The agency's actions in the decision-making process, in the words of the court, "reek of bad faith and improper behavior," which continues throughout the course of this litigation. Here are some highlights:
- There's no evidence that, until Plan B, the FDA has ever contacted the White House about an over-the-counter drug application. Not only was the White House contacted during the Plan B application process, but FDA officials have testified that decisions appeared to have been made in consultation with the White House and that officials involved in the process were concerned about their future if they did not fall in line with the administration's plan. (See pages 84-85)
- The FDA's actions on Plan B radically depart from typical agency practice and provide a text book example of an agency cavalierly setting aside its own well-established "prior norms" in order to achieve a pre-ordained and unlawful result. The Center's brief outlines fifteen examples of the agency acting outside the norm, from stacking the reproductive health advisory committee with "operatives" to making a decision to reject over-the-counter access to Plan B before the standard review was even completed. (See pages 86-90)
- Before its action on Plan B, the FDA has never restricted a non-prescription drug based on age. No FDA employee has offered a coherent scientific explanation for imposing an age restriction on Plan B. Instead, Commissioners have offered contradictory and non-scientific explanations to justify the age limit, demonstrating that the final decision to deny women under 18 over-the-counter access to Plan B was arbitrary and replete with bad faith. (See pages 44, 80-81)
Briefs on summary judgment motions from both sides are scheduled to be filed by June 15, 2007. After that point, the judge will make a decision in the case.
Find more news in the archive > >
Plan B In-Depth
Summary of the Plan B Case
THE FIGHT FOR EMERGENCY CONTRACEPTION: EVERY SECOND COUNTS
The Center Battles the FDA for All Women to have True Over-the-Counter Access to Plan B in Tummino v. von Eschenbach.