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Over-the-Counter Use Of Morning-After Pill Shot Down By HHS

December 8, 2011

In an abrupt decision that has angered some and delighted others, the U.S. Department of Health and Humans Services (HHS) intervened on Wednesday to prevent the FDA from making the controversial ℠morning after´ pill an over-the-counter medication available without a prescription to women of all ages.

Known as the ℠Plan-B´ pill, the emergency contraceptive can prevent an egg from being fertilized if taken within 72 hours sexual intercourse. Since appearing on the U.S. market over a decade ago, use of the so-called morning-after pill has been restricted to women over the age of 17 and requires a prescription from a medical doctor.

The FDA had planned to lift both the controversial age limit and the prescription requirement until HHS Secretary Kathleen Sebelius intervened this week to overturn the advice of the organization´s scientific experts, keeping Plan B behind the counter for the time being.

According to Sebelius, the reason behind her decision was the concern that the pill might be misused by extremely young girls who didn´t have a proper understanding of how the medication works and who would likely be aversive to getting help from an adult.

“It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age,” explained Sebelius in a press statement. “Because I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age, I have directed FDA to issue a complete response letter denying the supplemental new drug application.”

However, a number of women´s health advocates critical of Sebelius´s decision are already calling into question the altruism of Sebelius´s professed motives.

“What else can this be but politics?” questioned Cynthia Pearson rhetorically. The executive director of the National Women´s Health Network continued: “It´s not science. It´s not medicine. It´s not women´s health.”

Similarly, Kirsten Moore of the women´s advocacy group Reproductive Health Technologies Project alleged that the agency had let “politics trump science” and insisted that there was simply “no rationale for this move.”

Moreover, Sebelius´s decision isn´t just taking flak from women´s advocacy groups. In a more subdued but no less clear tone, FDA Commissioner Dr. Margaret Hamburg left no doubt that she found the HHS´s decision highly unusual as well, noting that her own scientists had in fact closely examined the issue of the medication´s use in young girls.

In contrast to Sebelius´s stated concerns, Dr. Hamburg insisted 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.”

Still, supporters of the HHS´s decision to maintain current restrictions on the pill have breathed a sigh of relief for now. One of their most repeatedly expressed concerns has been that the ease of obtaining the pill without a prescription could lead to currently unknown health issues and the potential for overdoses of the hormone if used too frequently.

Yet a more politically-charged issue has also been that teenage girls could take the medication without their parents´ knowledge, thus making it easier to conceal their sexual activity from parents.

In response to such worries, Sarah Brown of the National Campaign to Prevent Teen and Unplanned Pregnancies said that she could understand the reservations of those concerned with making it easier for young girls to get backup contraception. The problem is that statistics show that the concern is unjustified.

“The good news,” explained Brown, “is that there is simply no evidence to suggest that making contraception available to teens encourages them to begin having sex, have sex at younger ages or have more sexual partners. Moreover, most of us would rather have sexually active teens use contraception than become pregnant.”

The FDA´s prescription and age restrictions on the morning-after pill have already been taken to court once in 2009.  At that time, a federal judge commented that the government agency´s guidelines for obtaining the medication were of a political rather than medical nature and ordered that they reconsider them.

The FDA will have a hearing on December 13 to determine whether it should be held in contempt of court for refusing to revise its policy on the Plan B pill.

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Source: RedOrbit Staff & Wire Reports



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