News of the Day ... In Perspective08/27/2006
Over-the-counter “Plan B” sales approved for women over 18
Just after the Food and Drug Administration approved OTC sales of the “morning after” pill, two senators who had been blocking the permanent appointment of Dr. Andrew von Eschenbach as FDA commissioner said they would lift their hold on his confirmation.
By the year’s end, women over age 18 who want to buy “Plan B” emergency contraception can do so without a prescription. It will have to be dispensed from behind the counter by a licensed pharmacist to adults who present a valid photo identification. Men will be allowed to buy the drug for their partners (Andrew Bridges, AP 8/25/06).
Sen. Tom Coburn, M.D. (R-OK) observed that, according to Planned Parenthood’s website, Plan B is the equivalent of taking as many as 40 progesterone-containing birth-control pills.
“Never before,” he said, “has the FDA approved a medicine for over-the-counter sales when a lower dose of the same drug requires a prescription.”
Dr. Coburn states that women will be placed at risk by exposure to high-dose hormones without physician supervision. He also noted that teens “will likely discover obtaining morning after pills over the counter is as easy as obtaining alcohol.” http://www.humanlife.net/display_news.htm?nid=88
The “dual status” scheme “appears to be an entirely new type of approval that neither has been authorized by Congress nor subjected to a formal rule-making process,” stated Dr. David Stevens, Executive Director of the Christian Medical Association. He questions whether the FDA has the legal authority to approve a drug in this manner.
He also asks, “How does the FDA plan to prevent Plan B from being purchased by child predators and rapists and used to cover their crimes?”
CMA’s Associate Executive Director, Dr. Gene Rudd, said that the label is misleading, as it “involves a politically motivated redefinition of pregnancy.” Because many women would not take it if they realized the drug may prevent implantation of a fertilized egg, he believes it violates informed consent. http://www.humanlife.net/display_news.htm?nid=87
In a letter to Dr. von Eschenbach, Dr. Sharon Quick, Washington State Coordinator, American Academy of Medical Ethics, points out that emergency contraceptive use has been associated with an increased rate of sexually transmitted diseases and ectopic pregnancies. Moreover, the stated goal of preventing unwanted pregnancies and abortions has not been achieved. In Sweden, where emergency contraception is available without prescription, induced abortion rates in teenagers have increased. http://www.humanlife.net/display_news.htm?nid=84