FDA Brings Dismay, While Justice Provides Hope

When there is lightening, thunder usually follows. In the same way, you could almost sense an appeal today from the Justice Department for Judge Korman's ruling on emergency contraceptives, after yesterday's decision by the Food and Drug Administration allowing Plan B One Step to be sold over the counter to persons age 15 and older. Was that the compromise the Justice Department was waiting for before it decided to file an appeal?

Spokeswoman Erica Jefferson of the FDA assured me it was not. In an e-mail correspondence she wrote, "The FDA's approval of Teva's current application for Plan B One-Step is independent of that litigation and this decision was not intended to address the Judge's ruling."

She went on to state that the FDA took, "independent action to approve a pending application from Teva Women's Healthcare" for the approval of Plan B One-step.  "Additional time beyond the goal date was needed to review Teva's application to address questions including potential concerns about ensuring access to the product for women 15 and up, while limiting access for those under 15," she added.   Phone calls to Teva Pharmaceutical Industries, LTD, to receive a comment on the FDA's decision, were not returned. 

Ms. Jefferson concluded by saying that "additional data would be needed to show that younger women could use Plan B (the levonorgestrel two-pill dose) properly without the intervention of a health care provider before it could be available without a prescription for women 16 and under." 

In Judge Korman's ruling on April 5th he stated in his concluding remarks that if the FDA did believe there was a "significant difference between the one- and two-pill products, it may limit its over-the-counter approval to the one pill product." That concern was finalized yesterday by the FDA.

For the time, only Plan B One Step will be available over-the-counter at pharmacies and retail outlets, and the Justice Department has asked that Korman's ruling be suspended during the appeal process. According to court documents, the case will be heard in the 2nd U.S. Circuit Court of Appeals.

It seems the FDA and Justice Department attempted to find a middle ground on this controversial and divisive topic, and proof came when those on both sides of the issue expressed displeasure with yesterday's Plan B- One Step approval.  National Organization for Women president, Terry O'Neill, emphatically stated that yesterdays decision "Does not go far enough to allow emergency contraception to women of all ages," and groups from Christian and Family centered organizations have expressed grave concern that such a drug should be available to young children without parental consent. 

But credit must be given to the Obama Administration for having the common sense to appeal this ruling, even though there remains a plethora of moral education that still needs addressing. 

In a final thought, It is worth noting that NOW president Terry O'Neill chose the word "women" when describing those of all ages, as if to make no distinction between childhood and adulthood.  Judge Korman and the FDA also use a similar standard when determining whether such drugs as emergency contraceptives should be approved.  As both noted, if an individual is old enough to understand the label and its effect than the drug should be deemed safe.  But, what the preceding people have failed to address is that children or young adults do not have the wisdom, or properly formed conscience, to fully understand the results of their actions. Children most certainly could benefit from their parent's moral guidance on this issue. It appears the only winner in this epic battle, is the pharmaceutical manufacturers.

Eric and Julia Johnson

I will continue to bring readers lessons, literature and curricula in days to come.  Plan B diminishes  the trust in families and I believe that family is the intricate part of home education and Christian families alike.