According to MedPage, Judge Edward Korman of the US District Court's Eastern District of N.Y. cited political pressure as the reason for the decision in 2011 by the Department of Health and Human Services secretary Kathleen Sebelius to prevent the FDA from expanding over-the-counter access to the drug levonorgestrel, or the morning after pill, without age restrictions. Therefore, he has reversed the decision that restricted age to women 17 and older.
"Secretary Sebelius's directive to the FDA ... forced the agency to ride roughshod over the policies and practices that it has consistently applied in considering applications for switches in drug status to over-the-counter availability," Korman wrote in his opinion yesterday.
He ordered the FDA to "make levonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions within 30 days."
The new ruling has made Nancy Northup, president and CEO of the Center for Reproductive Rights, ecstatic. She told a reporter that access to women's reproductive rights should never be held hostage by politics.
Plan B was first approved for use in 1999 by prescription only; the FDA granted over-the-counter access to the pill for women 18 and older while maintaining the prescription requirement for younger females in 2006. In 2009, Korman ruled that the FDA must make the pill available without a prescription for 17-year-old girls as well.
Korman did not remove all age restrictions at that time, leaving the decision to the FDA with new leadership under Obama.
The manufacturer -- Teva Women's Health -- then submitted a supplemental new drug application seeking to allow over-the-counter access to girls and women of all ages.
The FDA initially approved the application, and commissioner Margaret Hamburg, MD, explained that the agency "determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases."
Sebelius disagreed with the decision and ordered the FDA to turn down that application, stating "that the data submitted for this product do not establish that prescription dispensing requirements should be eliminated for all ages." President Obama supported the decision.
Korman reversed that decision yesterday, but left open the possibility of further action from the FDA.
"On remand, the FDA may determine whether any new labeling is reasonably necessary," he wrote. "Moreover, if the FDA actually believes there is any significant difference between the one- and two-pill products, it may limit its over-the-counter approval to the one-pill product."
The American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the Society of Adolescent Health and Medicine, and Planned Parenthood all came out in support of the judge's ruling.
What it means: If nothing is overturned, girls as young as 12 could purchase the morning after abortion pill without parental involvement. Girls experiencing abuse by family members or having sex with older men could slip through the cracks with the loose regulations.
Girls as young as age nine are already experiencing mensuration due to hormones in the food they eat. They could be forced by an abuser to take the pill, miscarry a pregnancy and no one need ever know.
These girls are not ready to understand the consequences of taking an abortion-causing medication. The ease of obtaining the pills puts young girls at risk emotionally and psychologically.
This form of medicine is totally unnatural and potentially harmful to millions of young girls. If parents aren't outraged by this decision, there may be no hope for future generations. The ruling can only mean more money for the manufacturer of these pills.
Comments