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FDA Refrains From Releasing the "Morning After Pill" Over The Counter (5/04)

The Food and Drug Administration (FDA) decided 6May04 that it will not allow over-the-counter sales of Plan B, the “morning after pill” (MAP; often referred to as “emergency contraception” or EC).  The drug is dangerous for women and can result in an abortion if the female egg ovulated prior to receiving MAP. The long-term effects of such high doses of estrogen have not been sufficiently studied. (The devastating effects of DES took many years to determine.)

For more articles regarding MAP/EC, click here.

The FDA made its decision based on concerns about the effects of the drug on teenagers. It would have been very likely that teens would have been exposed to greater sexual predation. MAP/EC only affects pregnancy; it does not block STD infection.

However, it left the door open to allowing the drugs to be sold to adults. The agency also said it would reconsider its decision if Barr Laboratories, maker of the Plan B morning after drug, would provide more details on teen’s use of the drugs. Barr Labs said it was disappointed by the FDA’s decision. Barr chief executive Bruce Downey said his company would seek nonprescription sales approval again, but this time for people 16 years or older. “The FDA has also provided us with pathways to a future approval, and we are committed to following the pathways until we get this product on the market over-the-counter,” Downey said. Downey said he expected to be able to accomplish that in a matter of months. http://www.lifenews.com/nat498.html