So you thought it was all over, right: given the Federal Court s mandate by Judge Korman one month ago to make Plan B universally available OTC, and this week s decision by the FDA to do just that, but only for age 15 and up, the path to universal access to the morning-after pill seemed nice and greased.
But no: contrary to most people s expectations (including we here at ACSH), the U.S.Department of Justice has decided to enter the fray on behalf of ¦.well, that s the $64,000 question (or $64 million, adjusted for inflation). Without getting into the scientific and medical issues related to Plan B s (or Plan B One-step s) safety for young teenage girls, the DOJ objects to a federal judge ordering the FDA to take a drug-related action.
ACSH s Dr. Gilbert Ross had this perspective: This is really tricky, and a bit outside of our normal expertise. As best as I can explain it, while Judge Korman last month correctly accused the FDA of stalling based on political and moral concerns which have nothing to do with the mandate of the drug agency, and are misguided in any event the DOJ asserts that he over-stepped his bounds in attempting to force the FDA and the Department of HHS to approve a drug indication and OTC status based on his own interpretation of their motives. And that is outside the constitutional bounds of the separation of powers, i.e. the judiciary is enforcing its will on the executive branch in its own arbitrary and capricious approach, so the Justice lawyers say.
My own opinion, and I am not a lawyer, is that in this technical area, the DOJ is correct: the judge should have offered his firm opinion and remanded the lawsuit over Plan B back to the FDA for re-assessment based on his concerns, and let the system take its course thereafter. While again agreeing with Korman s opinion entirely, I do think he went beyond his scope. Let s hope the final outcome will take way less than a decade, as this litigation has done so far, and that women and girls who have risky sex or exposure to unintended pregnancy accidentally will be able to have unfettered access to emergency morning-after contraception.