A March 23 ruling about a petition to switch a prescription drug to over-the-counter status has nothing to do with torts, but it may have lots to do with how the FDA operated during the Bush II administration. It could be the first of many landmines to be unearthed at the agency, which rivaled the Justice Department for notoriety.

Plaintiffs sued the FDA for failing to take action on a citizens petition to switch the Plan B emergency contraceptive to OTC status. This wasn’t just a “hey, did you forget about this?” lawsuit, it was “you’re playing politics with this issue” lawsuit. And, according to Judge Edward R. Korman of the Eastern District of New York, the plaintiffs were right.

In an 52-page opinion that reads like a John Grisham/Tom Clancy thriller, Judge Korman writes that the Bush White House domestic policy office was involved in the issue, that high-level FDA officials took over decision-making from middle-level scientists and that Plan B was made to jump through scientific hoops that no other drugs were made to.

FDA watchers know that it’s not unusual for the agency to not respond to citizen petitions for several years (aside from “got your letter, we'll get back to you”). But Plan B got stickier when the manufacturer sought the OTC switch. Since the FDA now had to put the issue before an advisory committee, Judge Korman said the FDA was told to seat new members for ideological balance, to wit, people from the anti-abortion camp, or the White House constituency.

To make a long story short, the FDA hemmed and hawed, and the manufacturer offered different suggestions. Eventually, the agency decided that Plan B would be behind-the-counter for 18-year-olds, but prescription for those under 18. Not only did Plan B become the first OTC switch to not make it on the first go-around, but it became the first drug to be prescription for one age and behind-the-counter for another. The FDA apparently thought the resolution was its silver bullet, end of story. But Judge Korman let the case proceed, finding evidence that the FDA didn’t act in good faith (maybe that was the meaning of faith-based initiatives). Bottom line: Judge Korman ruled that the Plan B switch was influenced by politics and ordered the FDA to make Plan B available without prescription to 17-year-olds while the agency went back to the drawing board.

In the meantime, as Judge Korman observed, things have changed in Rockville, Md.: the two commissioners who presided over the Plan B Affair are gone, and a new commissioner is nominated. Thus, it’s unlikely the new FDA leadership is going to appeal.

But the Plan B Affair is may be indicative of revelations to yet come about how the FDA operated between 2000 and 2008. Recall that FDA staffers made it known during the Bush years that they felt pressured by senior management if they spoke up about drug and device safety issues. Some dissidents bucked chain of command and were called before Congress to testify about drugs and devices they say shouldn’t have been approved or that should be withdrawn. There have been published reports that dissidents within the FDA’s device section have written to Congress and even then-President-Elect Obama about how they felt pressured to approve devices. Rep. Henry Waxman, the FDA’s arch-enemy if there ever was one, now has the bully pulpit. Perhaps worst off all for those who played politics, Dr. Joshua Scharfstein, a former staffer of both Waxman and FDA watchdog Public Citizen Health Group, is now the acting FDA commissioner. Assuming there was no Ollie North-style shredding party before Jan. 20, Scharfstein now had the files and FDA dissidents will have his ear about other instances of politics trumping science in the past eight years.