FDA approves over-the-counter sale of generic versions of Plan B
WASHINGTON, D.C., March 3, 2014 (LifeSiteNews.com) – Less than a year after approving Plan B One-Step for over-the-counter sales, the Food & Drug Administration (FDA) has said generic versions of Plan B can be sold without a prescription.
Last July, a court order forced the Department of Health & Human Services (HHS) to sell the emergency contraception without age limitations and without a prescription. The decision came after years of lobbying by leftist groups to allow over-the-counter access to the potent, and potentially abortifacient drug, to underage girls.
Although initially the Obama administration had opposed the court order, they dropped their appeal against the decision in June of last year, paving the way for girls as young as 11 to purchase Plan B off the shelf at pharmacies.
However, federal officials had not made generic drugs over-the-counter, instead granting One-Step maker Teva Pharmaceuticals a three-year exclusivity deal because it had conducted a study on the effects of Plan B on teenagers. Such arrangements are standard policy in order to incentivize pharmaceutical companies to fund new research.
However, in a recent letter FDA officials explained that it considers Teva's argument that competitors should not be allowed to sell their version of the product without age restrictions and without a prescription “too broad.”
The new policy strikes a compromise, allowing the generic versions of Plan Be to be sold over-the-counter as long as the product includes a warning that it is intended for "women 17 years of age or older.” There is no requirement for proof of age, however.
The move has been praised by pro-contraception organizations because generic products can be more than $10 cheaper. However, the increased competition comes with harm to women, says Theology of the Body Institute Executive Director Damon Owens.
“The FDA is doubling down on the harmful and dangerous quest to make non-procreative sex 'safe and effective',” says Owens. “Mega doses of these Class A carcinogenic steroids are far from a healthy practice for women, children, and families that over-the-counter status connotes. It is only justified by the unspoken underlying belief that pregnancy - the natural result and purpose of sex - is far worse than the real health threat of the unsupervised use of hormonal contraceptives.”
Owens also criticized “non-procreative 'experts'” who, he says, “prefer women subjecting themselves to daily doses of steroids from menarche to menopause, backed up by higher doses in 'emergency contraception,' then backed up by abortion on demand.”
Pro-life organizations and individuals have long expressed concern about the quality of the studies done on the effects of Plan B on women, especially teenagers. The FDA cited Teva's studies in claiming Plan B is safe for use by all women, including teenagers.
In addition to arguments that the drug is dangerous for women, there is also evidence that it may sometimes act as an abortifacient, preventing the implanation of a newly conceived embryo in the mother's womb.
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