Back in 2005 and 2006, I wrote a few posts about the insanely arbitrary decision making process that the FDA was pretending to use to justify its obviously pre-determined conclusion to restrict the availability of the Plan B "morning after" pill as much as they thought they could get away with. The FDA ultimately decided to deny applications to fully move Plan B to over-the-counter status, but finally accepted a request to waive the prescription requirement for patients 18 years old or older. That was in August of 2006, and that's been the status quo ever since. Until this morning.
Earlier today, Judge Edward Korman of the Eastern District of New York issued a ruling on a lawsuit brought by individuals who had petitioned the FDA to make Plan B available without prescription or age limitation. It would be a bit of an understatement to say that Korman was highly critical of the FDA's alleged process in this case. The ruling stopped short of being everything that the plaintiffs asked for, but not by much.
Here's the bottom line:
1: Korman ruled that the entire Plan B over-the-counter decision making process was arbitrary and capricious. He also ruled that the FDA did not act in good faith, and that the process was clearly tainted by inappropriate political considerations. He vacated the FDA's denial of the petition to make Plan B available without prescription or age restriction, and has ordered the agency to go back and try to address the petition properly.
2: Korman also ruled that the FDA's decision to deny Plan B to 17 year olds was based on something so "implausible" that there is no need to order the FDA to review the decision. He's given the FDA 30 days to issue an order permitting the manufacturer to make Plan B available to 17 year olds without prescription.
The Judge Korman's decision provides an excellent overview of the politically tainted process that led to the treatment of the Plan B process. I'll probably have more to say about that tomorrow, after I have a chance to read the decision again while more fully awake.