FDA's rejection of morning-after pill bizarre

[Guest guest]

Category: Women's Health/OBGYN News

Article 15 Nov 2005

 

 

 

 

 

 

In May 2004, federal drug officials rejected an application to allow

OTC sales of the morning after pill (Plan B) even though a government

scientific review of the application was still ongoing. In other

words, they rejected the submission without waiting to hear what the

scientists had to say - this is unusual.

 

In fact, the GAO (Government Accountability Office) reports that the

rejection was strange in many ways. High ranking officials were very

involved in the decision (to reject the application), these high

ranking officials ignored government and its own scientific reviews,

they also told the FDA review staff that the final decision would be

made by the upper management.

 

Plan B is a controversial drug. Some people believe it amounts to

abortion because it is taken a day after possible conception. The FDA

and the government scientific reviews classed the medication as a

contraceptive (not abortion).

 

Julie Zawisza, spokesperson for the FDA, says the agency stands by

its decision to turn the morning after pill application down.

 

Planned Parenthood Federation of America is accusing the FDA of

playing politics with women's health.

 

Written by: Christian Nordqvist

Editor: Medical News Today