The Park Doctrine: FDA Issues Their Position: "Like, Oh Well, Whatever"

FDA Law Blog has;

This pdf explaining What the Park Doctrine is.

Fda-And-The Park-Doctrine

from their main post:

FDA Finally Releases "Non-Binding" Park Doctrine Criteria

What's at stake is Pharma Upper Management being held responsible for what those beneath them (whom they're getting the big money to Be responsible for) do.

At Pharmalot:

The FDA Criteria For Going After Pharma Execs has;

"These moves also come as the Health and Human Services Office of Inspector General pushes for measures to make it possible to ban pharma execs from doing business with federal health programs, if their companies have been convicted of fraud."

&, FDA's Regulatory Procedures Manual > 6-5 PROSECUTION

Perhaps a "Binding Position" on such issues might be easier for FDA to reach if they weren't so dependent upon the industries they're regulating for such a large chunk of their operating expenses.

Prescription Drug User Fee Act (PDUFA) > PDUFA User Fee Rates Archive

Uh hunh. While they're allowing onto the market such "safe & effectives" as:

Mental Health: Comes With FREE Sudden Death

We have to go with Forbes on this latest piece of "Look at Us! We're actually Doing Something!"

"As others have correctly observed, the FDA’s non-binding criteria is full of sound and fury, signifying nothing."