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CMA Doctors: FDA Scheme for 'Plan B' is Medically and Legally Questionable

Contact: Margie Shealy, Christian Medical Association, 888-231-2637, 423-341-4254 cell, margie.shealy@cmda.org

 

WASHINGTON, Aug. 24 /Christian Newswire/ -- The nation's largest faith-based association of doctors today issued a statement opposing the FDA's decision to allow "emergency contraception" to be purchased without a physician's prescription and oversight, with the intended exception of purchases by minors.

 

Dr. David Stevens, Executive Director of the 17,000-member Christian Medical Association (www.cmda.org) noted, "The FDA's plan seems designed as a political compromise, but the FDA is supposed to insure health and safety apart from politics. The FDA seems to be making the same mistake with 'Plan B' that it made with RU-486--making a decision influenced by political pressure.

 

"Removing this high dose of hormones from a doctor's oversight removes a vital safety protection from women. Like any drug, this drug involves side effects and risks, and its use needs to be carefully considered by a physician in light of an individual's medical history. Removing the drug from a doctor's care also circumvents routine screening for sexually transmitted diseases in a vulnerable population, which will put women at further risk. There is evidence suggesting that sexually transmitted diseases have actually increased where the drug has been offered non-prescription basis. The drug has not been shown to decrease abortions as claimed.

 

"This 'dual status' scheme that the FDA has devised appears to be an entirely new type of approval that neither has been authorized by Congress nor subjected to a formal rule-making process. We anticipate questions as to whether the FDA has any legal authority to approve any drug in this manner.

 

"We also question the FDA's enforcement authority and ability to ensure that this scheme is followed. How does the FDA plan to prevent Plan B from being purchased by child predators and rapists and used to cover their crimes? How will it prevent an adult from purchasing the drug for a minor?"

 

CMA Associate Executive Director Dr. Gene Rudd said, "As an obstetrician, I am especially concerned about the drug's misleading labeling. Many women in America would not take it if they realized that it can have the effect of preventing a fertilized ovum--a living human embryo--from implanting in the womb and having a chance to be born.

 

"This drug's misleading labeling, which involves a politically motivated redefinition of pregnancy that is not accepted by many pro-life women and physicians, violates the crucial medical principle of informed consent."

 

To schedule an interview, please contact Margie Shealy at (423) 844-1047 or by e-mail: margie@cmdahome.org. The Christian Medical Association is equipped with Ku Band Digital Uplink satellite and ISDN lines.