Credit: Princeton
In April, a federal court ordered the Obama administration to make Plan B emergency contraception available without a prescriptionn to all females of reproductive age. Yesterday, the FDA ruled that women over the age 15 could have over-the-counter access to the pill. Also, yesterday the FDA filed an appeal of the district court's ruling. According to the Washington Post, the U.S. Justice Department had the bald-faced temerity to argue:
"The Court's Order interferes with and thereby undermines the regulatory procedures governing FDA's drug approval process," the Justice Department said. "A drug approval decision involves scientific judgments as to whether statutory and regulatory factors are met that warrant deference to those charged with the statutory responsibility to make those decisions."
So just what exactly was the FDA's actual scientific judgment about Plan B. Jumping into our policy WABAC Machine and we find the following December 7, 2011 statement from FDA Administrator Margaret Hamburg:
The Center for Drug Evaluation and Research (CDER) completed its review of the Plan B One-Step application and laid out its scientific determination. CDER carefully considered whether younger females were able to understand how to use Plan B One-Step. Based on the information submitted to the agency, CDER 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. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider. It is our responsibility at FDA to approve drugs that are safe and effective for their intended use based on the scientific evidence. The review process used by CDER to analyze the data applied a risk/benefit assessment consistent with its standard drug review process. Our decision-making reflects a body of scientific findings, input from external scientific advisory committees, and data contained in the application that included studies designed specifically to address the regulatory standards for nonprescription drugs. CDER experts, including obstetrician/gynecologists and pediatricians, reviewed the totality of the data and agreed that it met the regulatory standard for a nonprescription drug and that Plan B One-Step should be approved for all females of child-bearing potential. I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER, and I agree with the Center that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.
What's especially ridiculous is that the folks in the Obama administration overruled the scientific determinations of the FDA and arbitrarily imposed age restrictions on the availability of Plan B out obvious electoral considerations. Since the president can't run for office again, the only plausible reason that the Justice Department would oppose making Plan B available without a prescription to all women of reproductive age now is out of sheer embarassment at the fact the administration would be admitting its original decision was completely political.
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