Wednesday, November 14, 2012

Curiouser and Curiouser

"Well, I thought it
would make you smaller!"
This is interesting.

Last month, we reported that the International Academy of Compounding Pharmacists had sent their members a memo that offered explicit instructions on how to stonewall a Food and Drug Administration investigation of a drug called 17-P. Call them “balking points,” if you will.

Specifically, the IACP told their members that if the FDA asked for samples of the drug, they should say: “We do not maintain compounded 17-P in stock because our pharmacy prepares 17-P upon receipt of a prescription from a patient or prescriber.” 

Apparently through some rabbit-hole trickery, the New England Compounding Center—the company at the center of the viral meningitis outbreak that has claimed at least 32 lives—got the IACP memo eight years before it was written.

According to The Washington Post, during a 2004 investigation of a medical dye called Trypan Blue, the FDA asked NECC co-owner Barry Cadden if he had any samples of the drug in stock. The FDA reported that Cadden said, “no because he just compounds the drug if he receives the prescriptions for certain patients.” But, sure enough, the FDA found 189 vials of the drug in a drawer marked “Trypan Blue.” (Those wily sleuths!)

Despite being caught blue-handed, NECC must have appreciated the futuristic advice because a year later Cadden made a donation of between $2,500 and $5,000 to the IACP’s legal defense fund. In 2009, the IACP declared, "To continue to champion the cause of pharmacy compounding and contend with entities such as FDA, we must not only be equipped with fighting words, but fighting dollars as well."

And they have put their money where their mouthpieces are. According to the Insurance Journal, “The International Academy of Compounding Pharmacists has spent more than $1 million lobbying Congress in the past decade and has a track record of defeating measures opposed by the industry. A 2003 provision to set up an FDA advisory committee to oversee compounders was killed by then-House Majority Leader Tom Delay, who said it would create unnecessary federal interference. Delay represented Sugar Land, Texas, the headquarters of the compounding academy.”
"What hookah?"

Now, there is absolutely nothing wrong with a trade association doing whatever it can (legally and transparently) to protect the interest of its members. In fact, trades have a responsibility to fight for their members' interests with all they've got. But the fight must be an honest one. 

The days or surreptitious shenanigans and hidden hijinks are over. You can no longer make your words mean what you want them to mean. The time has come, my little friends, to talk of real things.

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