Bush administration plays to religious right in delaying contraceptive approval
By Naomi Spencer
26 November 2005
A new report from the US Government Accountability Office into deviations in Food and Drug Administration (FDA) procedure reveals ideological meddling by high-ranking officials in the Bush administration. The administration has stonewalled the review process of the emergency contraceptive Plan B for the past two years to appease the administration’s religious base, trampling on science and the agency’s own procedure.
In April 2003, Plan B manufacturer Women’s Capital Corporation submitted an application to the FDA to have the availability status of the emergency contraceptive pill switched from by-prescription-only to over-the-counter (OTC). Plan B had already been approved by the FDA in 1999 as a prescription contraceptive.
The pill, which contains in stronger dosage the chemicals present in widely-used birth control pills, is formulated to prevent unwanted pregnancy if taken within 72 hours of unprotected sex. Because it is most effective if taken as soon as possible after intercourse, the case for non-prescription availability is one of practicality, common sense, and reproductive choice.
In 2004, Plan B was refused OTC status because of lack of data on the effects accessible emergency contraception would have on the behavior of teenagers. The concern that teenagers may engage in more risky sexual behavior if they have access to birth control has also been raised by the conservative right with regard to sex education curriculum, and is groundless. This moral policing has nothing to do with testing the safety and efficacy of the drug.
Barr Laboratories submitted a revised application which restricted OTC access to the drug to women age 16 and older. This was neither rejected nor approved by the FDA, but was simply suppressed for a year. The OTC availability age limit was raised to 17 by FDA reviewers in an attempt to placate conservatives within the agency, but on August 26, the review process was indefinitely deferred on the pretext that a new clinical trial on children must first be conducted.
http://www.wsws.org/articles/2005/nov2005/plan-n26.shtml