It was the equivalent of David taking down Goliath: Earlier this year, compounding pharmacists stood up to a drug company -- and won big.
But in this version of the tale, Goliath doesn't lie down and die. He gets back up -- and now, he's really ticked off.
Before I get into that, let me recap the story so far: For years, compounding pharmacists made a generic version of 17-hydroxyprogesterone, a hormonal treatment given to pregnant women to lower the risk of a preterm birth.
Despite its wide availability, it was considered an "orphan drug" by the FDA -- allowing KV Pharmaceuticals to swoop in, slap a patent on it, and re-name it Makena earlier this year.
Then, the company raised the price to $1,500 a shot and threatened legal action against any compounding pharmacist who continued to make the cheap generic version.
Naturally, women were outraged -- and they remained outraged even when the company cut the price to "only" $690 a shot. And that's when the FDA stepped in and told compounding pharmacists not to worry -- they could keep making their own version of the drug.
Believe me, I'm still rubbing my eyes over that one.
But maybe it really was a dream after all, because the company is still trying to get the generic hormone pulled from the market.
And this time, they might succeed.
KV quietly ordered samples of 17-hydroxyprogesterone from a handful of compounding pharmacists, then hired a lab to perform tests on behalf of the company.
No conflict there, right?
Naturally, the tests "found" that the compounded product was indeed different from Makena, which isn't the point.
Of course they're different -- they're custom-made, but that doesn't mean the product is bad. There's no evidence that these variations make the treatment any less effective, and no evidence they pose any more of a risk than Makena.
In fact, the same people who produced these "bad" samples are the same compounding pharmacists who've been reliably making the treatment for years -- giving them a much better real-world track record then Makena.
But the company sent its test results to the FDA, and the agency is now "investigating." The feds even sent out a reminder saying that approved drugs like Makena come with a "greater assurance of safety and effectiveness" than those from compounding pharmacists.
Stay tuned... but I think that last bit is a sign that the writing's on the wall: Goliath is back on his feet.