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FDA decision scrutinised

A federal court has ruled that the FDA's decision to deny women under 18 access to OTC emergency contraception reflected political and ideological concerns rather than purely scientific ones

A federal court has ruled that the US Food and Drug Administration's (FDA) decision to deny women under the age of 18 access to over-the-counter (OTC) emergency contraception reflected political and ideological concerns rather than purely scientific ones.

The US District Court for the Eastern District of New York said the FDA's stance on the OTC switch for Barr Laboratories' Plan B under the Bush Administration reflected "political considerations, delays, and implausible justifications for decision-making". The court also found evidence of "pressure emanating from the White House, and the obvious connection between the confirmation process of two FDA Commissioners and the timing of the FDA's decisions".

As a result, the court ruled that the FDA must take action within 30 days to make Plan B, which is the only morning-after pill marketed in the US, OTC to women aged 17. The FDA has also been instructed to reconsider whether minors under the age of 17 should be permitted to obtain emergency contraception without a prescription, this time basing its review purely on scientific data.

At the moment, Plan B can be sold OTC to women aged 18 and older, and with a prescription to women younger than 18. But advocates for emergency contraception, including the coalition of women's groups that filed the lawsuit against the FDA, point to a number of studies suggesting that teenagers would use emergency contraception responsibly if it were made available to them without a prescription, and that they wouldn't rely on it as a regular method of birth control, as some opponents fear.

Women's groups including the Women's Liberation Birth Control Project, which is led by Annie Tummino, filed the lawsuit, known as Tummino v Von Eschenbach, against FDA Commissioner Andrew von Eschenbach. The suit claimed that, in response to political pressure, the way the FDA handled the OTC switch application for Plan B was differed compared to its handling of other applications; in violation of the agency's own regulations.

Among the plaintiffs' evidence was a November 2005 report from the Government Accountability Office that looked at the 68 switch applications the FDA reviewed between 1994 and 2004, and found that the agency followed its advisory committees' advice in every instance except when considering Plan B.  In late 2003, the FDA's expert advisers recommended an OTC switch for Plan B, but the FDA did not approve one, saying that some members of the committee, including the chair, had raised concerns at the meeting that the agency wanted to see addressed. The FDA eventually approved the switch in August 2006, but only for women 18 and older.

Addressing the delays and the limited nature of the OTC approval, the court determined that "the FDA simply has not come forward with an adequate explanation, nor has it presented any evidence to rebut plaintiffs' showing that it acted in bad faith and in response to political pressure".

26th March 2009

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