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CWA: FDA Oversteps Authority by Approving Non-Prescription Access to Morning-After Pill 8/24/2006 Washington, D.C. – Concerned Women for America (CWA) strongly opposes today’s decision by the Food and Drug Administration (FDA) to approve Plan B, the morning-after pill, as a non-prescription drug. This decision allows anyone over 18 to purchase the drug without a prescription, thereby making the drug accessible to minors who can easily obtain the drug from those meeting the age requirement. The FDA has overstepped its authority in this decision and the result will be young teens who get a high dose drug without their parent’s knowledge or physician’s oversight.
“The FDA’s decision today will have a detrimental affect on women and parents around the country,” says President Wendy Wright. “If the FDA thinks that enacting an age restriction will work, or that the drug company will enforce it when it has already announced it has no intention of enforcing it, then they are living in a dream world. Enforcement requires a penalty for violating the restriction. The FDA has no authority or ability to enforce an age-restriction, and Barr, the Plan B drug maker, has neither the ability nor the willingness. The most it could do is not supply the drug to a violator—something that will never happen.
“Barr's President Bruce Downey told reporters last week that Barr does not intend to enforce the age restriction. He claims that he's confident pharmacists would obey the law. But there is no law. There would only be an agreement between FDA and Barr and we've seen how useless that is. For example, the FDA made a deal with the owner of RU-486 to apply restrictions on that drug. Those restrictions have never been followed, women have died, yet no one has been punished nor the drug approval pulled,” said Wright.
“Parents should be horrified that a drug like Plan B will be easier to get than a low dose of the same drug. Their young daughters will now have this super-dose of hormones easily available, without any requirement for parental consent or medical oversight. Any adult male who is having sex with a minor could walk into a pharmacy, buy the drug, and coax the girl into taking the pill. Parents have the right to know their daughter’s medical needs and to support them in the process. The FDA’s irresponsible action today takes those rights out of a parent’s hands and gives them to ill-intentioned perpetrators.”
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