The US Food and Drug Administration announced Friday that it will delay a decision on allowing sales of the abortifacient morning-after pill without a prescription.
After a failed bid last year by the drug’s manufacturer, Barr Pharmaceuticals, to have its Plan B approved for over-the counter (OTC) use, the company re-submitted its application with the provision that sales of the abortifacient would only be OTC for girls older than 15 years of age.
An FDA release stated that the application from Barr presented the agency “with many difficult and novel policy and regulatory issues.” Some issues the FDA called “unprecedented,” such as whether age can be “used as a criterion on which we decide whether a drug should be prescription or over-the-counter.” Additionally, the FDA wondered how pharmacies would enforce age restrictions when it came to sales of the abortifacient.
“We believe these novel regulatory issues should be considered in an open, public process,” stated FDA Commissioner Lester M. Crawford. “These regulatory and policy questions are too profound and cut across too many different products to be made behind closed doors.”
“FDA used to prohibit products from being both over the counter and prescription at the same time,” Crawford explained. “They had to be one or the other. The idea was that if an active ingredient was safe and effective without a practitioner’s supervision it had to be over-the-counter. If it needed a prescription for one group of people, then it needed a prescription for all people.” Since the 1980s, a few products were made available both as prescription and over the counter, because they were used for different purposes. Plan B is unique in that it would be sold OTC and by prescription for the same use and in the same package.
Bruce Downey, CEO for Barr commented that awaiting the FDA decision is “like being in purgatory,” according to an AP report.
The American Association of Pro-Life Obstetricians and Gynecologists (AAPOG) expressed its concern over a heightened incidence of sexually transmitted disease. “Chlamydia, a STD already seen in epidemic proportions among teens and college age women, would go undiagnosed and untreated, scarring fallopian tubes, and resulting in future infertility for many,” the group stated, according to a release. “Human Papilloma Virus, a widespread and very communicable STD, is associated with the development of cervical cancer, and untreated HPV would put many women at future risk for this deadly cancer.”
“However you look at it, Over-The-Counter ‘Emergency Contraception’ is bad medicine for women,” the AAPOG concluded. “The FDA has asked for input. We strongly urge parents and doctors alike to express their feelings to the FDA.”
Concerned Women for America’s Wendy Wright said, “Making the morning-after pill over-the-counter would only benefit those that profit from its increased sale, but the real price will be paid by women and girls who would suffer the health consequences.”
See the FDA statement here.
(This article courtesy of LifeSiteNews.com.)
