FDA Whistleblower Causes Uproar Over Morning-After Pill

 

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According to an interview with Susan Wood, PHD, a former employee of the US Food and Drug Administrator (FDA), the regulatory process for approving the pill was interfered with and thus invalid.

Wood, a former assistant commissioner of women’s health at the FDA, she noticed that something was wrong in 2004. After an advisory committee, the decisions on whether or not to have an age restriction on the pill skipped the chain of command and went right into the higher echelon of the administration.  According to Wood, “It wasn’t until August 2005, when yet another delay for approval was imposed, that it became clear to me that that the process was wrong to the point of my not seeing how it could be fixed, and that’s when I left.”

Dr. Wood further says “I’ve been careful over the years not to speculate on how the decision was taken off track. Certainly there was the thought that is was political, but what I really want to point out is that the science was ignored — medical evidence was ignored, and the way that the FDA usually does business was ignored, and that led to bad decision-making.”

Wood chose to not stay, as she felt the environment would have been too stressful. She felt that she had to either become a whistleblower or “remain silent, and thereby undermine [her] own professional and scientific credibility.” Wood resigned formally in August 2005, on principle in response to the FDA’s unnecessary delay on the approval of Plan B.

When Dr. Wood left the FDA, the National Organization for Women (NOW) saluted her as a woman of integrity.  NOW President Kim Gandy identified Dr. Wood’s departure as  “a tremendous loss to the women’s health community, and is an indictment of the Bush political appointees who have turned the agency from medical science to political ideology.”

Sources
http://www.medscape.com/viewarticle/739144
http://www.now.org/issues/reproductive/083105_ec_fda

 
 
 

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