Thursday, March 31, 2011

Picking and Choosing: The Makena Saga continues...

Does the FDA have the right to selectively enforce its own reg's? Reason I ask is this:

"Responding to the public and political pressure, the FDA said it had no intention of blocking pharmacies from selling their own versions of Makena."

By way of background, Bob reported several weeks ago that the price of Makena (a progesterone synthetic) was set to go from $20 a shot to $1500 a pop. Talk about a rate increase! As usual, though, there was more to the story than first met the eye:

"That's because the drug, a form of progesterone given as a weekly shot, has been made cheaply for years, mixed in special pharmacies that custom-compound treatments that are not federally approved."

Since it didn't need FDA approval, the exorbitant costs associated with gaining that approval didn't apply. Pretty much everything the gummint touches, however, begins to cost more gold, and the price of course skyrocketed.

Now, the technology to actually produce the medication didn't disappear overnight from the local apothecary; it was just that the heavy hand of the government had come down upon it, in the form of a letter from the manufacturer to said pharmacists, "warning them of possible FDA enforcement action if they kept compounding the drug."

This is as much a protection for the consumer as the manufacturer, of course, but fine-wary druggists were understandably concerned that they'd be fried under a Federal microscope.

Never fear, however, because the FDA itself has now publicly folded their hand, announcing that they have "no intention of blocking pharmacies from selling their own versions of Makena."

That's correct: they're going to preemptively cede control to the private sector, and abrogate their legal duty to enforce regulations.

This is unconscionable: once the agency stops enforcing one such regulation, how can they enforce others? Obviously, the neighborhood pharmacy just got an FDAWaiver©.

Quelle surprise.
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