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Battling the FDA to Gain Access to Emergency Contraception for Women of All Ages

Written By: Suzanne Novak
November 24, 2010

 

Nine years, 10 months and 28 days.  That’s how long over 70 organizations have been waiting for the Food and Drug Administration to make a straightforward, science-based ruling on a Citizen Petition requesting that emergency contraception (EC) be made available in the United States without a prescription for women at every age.  The science has shown that the petition should be granted.  But the FDA’s repeated inaction and insistence on letting politics trump science—both in the Bush and the Obama administration—has left the Center for Reproductive Rights (CRR) with no choice but to drag it into court under the serious charge that it has defied a prior federal court order and made no effort (and has no intention of making any effort) to rule on the Citizen Petition.

How did we get here?  After the Citizen Petition was submitted, the manufacturers of the emergency contraceptive brand Plan B also filed an application with the FDA asking that Plan B be made available over-the-counter. Soon after, FDA scientists overwhelmingly recommended that the application be approved. In fact, an internal FDA memo acknowledged that the clinical data before the agency “clearly supports” making Plan B available without a prescription “for all age groups,” and that such approval would be “consistent” with previous decisions on other products.

But FDA higher-ups ignored that recommendation, the scientific evidence, and repeatedly and unreasonably delayed issuing a decision on Plan B.  A ruling was issued only after CRR filed a federal lawsuit against the FDA in 2005. During discovery with high-level officials in the agency, it became clear that the FDA had stepped outside of its normal procedures, including consulting with the Bush administration about the application.  Months of testimony by senior FDA officials and documents indicated that the Bush administration sought to unduly influence the agency during the Plan B review process.  According to depositions, officials involved in the decision-making process were even concerned about losing their jobs if they did not follow the administration’s political directives. As a result, CRR declared its intention to seek discovery of White House documents describing the White House’s role in the FDA’s review of the drug.

Under pressure at that point, the FDA finally made a decision, but with a caveat. The agency denied the Citizen Petition. It approved access to Plan B without a prescription, but only to women 18 and older, only behind pharmacy counters and only after government-issued identification is shown. This was in direct contradiction to the FDA expert panel that recommended true over-the-counter availability of Plan B. And before this decision, the FDA had never restricted a non-prescription drug based on age.

Accordingly, in 2009 the federal judge in CRR’s case determined that the FDA had broken its own rules and regulations by caving to political pressure and departing in significant ways from its normal procedure, including making an initial decision to reject the Plan B application even before the scientific reviews were completed(!).  The court concluded that the FDA had acted in bad faith. The judge ordered the FDA to reconsider the Citizen Petition and noted that under a new administration, and therefore new FDA leadership, “a fair assessment of the scientific evidence” would be in order. One would think those findings and that directive would be enough to spur the FDA into action.  But it didn’t.

In a series of letters with CRR, the FDA initially indicated that it was going to follow the court order and was “actively engaged” in reconsidering the Citizen Petition, including the current age restrictions (though, as it has throughout the court case, refusing to provide any further detail).  But there was no action.  Then in August 2010—one-and-a-half years after the court ruling—the FDA did an about-face.  It informed CRR that it thought the best way to comply with the court order was, essentially, not to comply with it at all.  Rather than rule on the Citizen Petition, the FDA indicated that it was going to wait for a manufacturer application requesting teen access that might be filed, at some indefinite time in the future, along with age-specific data.

So here we are again— we wish it weren’t necessary, but we will continue to drag the FDA into court until it stops stalling, refusing to follow the scientific evidence, and playing games with women’s lives and health.  Teens should not be denied reasonable access to safe and effective forms of contraception for no reason and the FDA should not be permitted to disregard court orders at its whim.

Suzanne Novak is a Senior Staff Attorney at the Center for Reproductive Rights.

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