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Example 3 - Emergency Contraception

The continuing saga of over-the-counter emergency contraception is a third egregious example of government censorship.

I testified before the FDA in December 2003, as did many others. The review was thorough and scientific. After a resounding endorsement by the joint committees, with a vote of 23 to 4 to approve over-the-counter access to the emergency contraceptive, Plan B (Barr Laboratories), we were confident emergency contraception would soon be more accessible to women in need.

No so. On May 6, 2004, a single FDA bureaucrat -- Steven Galson, Acting Director of the FDA's Center for Drug Evaluation and Research -- an appointee with little FDA experience, overruled the advisory committees and the FDA's own staff. The sole reason stated was insufficient evidence from a tiny subgroup of participants -- adolescent women younger than 16 years of age. Ironically, the FDA had previously approved the actual-use study as designed, noting that it would meet the FDA's needs. Then the rules changed, a clear Catch 22 .

To accommodate the FDA, Barr Laboratories revised its application to the FDA. It requested over-the-counter availability only for women 16 years and older; younger teens would still require a prescription. After the allowable 180 days for FDA review, the FDA's response was....

Here you see the verbatim response. Although required by federal law to approve, decline, or specify other issues, the FDA violated federal law and stonewalled once again. Anticipating this obstructive behavior, the Center for Reproductive Rights sued the FDA in federal court the very same day. So, the FDA made a medically indefensible decision and then, when challenged, responded with no decision at all. Our tax dollars are paying for this charade.

Given the FDA's alleged concern about the safety of over-the-counter levonorgestrel, their approval of over-the-counter sales of defibrillators last fall seems peculiar. Any 13-year-old with a credit card and the inclination can buy an automatic defibrillator that delivers hundreds of joules of electricity.

While the FDA continues to stonewall, Canada, a neighbor not known for radical drug regulatory policies, approved emergency contraception without a prescription. Response from the FDA? You guessed it.

ACOG[15] and other professional organizations have for years specified that provision of emergency contraception is a fundamental component of the care of sexual assault victims. So when the Department of Justice's Office on Violence Against Women finally released the first national protocol about the care of such women,[16] we expected to find explicit details on provision of emergency contraception in this 141-page document. Not so. Here is everything the federal government has to say about emergency contraception.

Even the words "emergency contraception" have been purged from the section entitled "care." The national outcry over this omission was prompt, loud,[17] and, as usual, ignored. While the White House advises all women to "just say no" to sex outside of marriage, how are rape victims to comply with this edict? They said no... to no avail. The Department of Justice today is clearly more concerned with appeasing the radical right than providing guidance to clinicians and law enforcement officers on proper care of victims.


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