I don't think Steve Kagen is capable of keeping a low profile.
He's definitely the class clown among the freshmen of the 110th Congress.
We know that he's racially insensitive. He's a braggart. He's a liar or a rude slob or both.
We also know that he's a nut, a law-breaking nut.
(AP) WASHINGTON -- Federal health officials have warned freshman Rep. Steve Kagen that his Wisconsin allergy practice is in apparent violation of federal law for manufacturing and selling allergy shots without a valid license.
According to a letter sent to Kagen by the Food and Drug Administration, Kagen manufactured a variety of ragweed and grass allergen vaccines from commercially distributed pollen and sold the shots to patients at his clinic and in at least 24 other states.
The FDA letter, which was dated Dec. 18 but wasn't posted online until Thursday, said that Kagen, D-Wis., did not have a valid license required for introducing a biological product into interstate commerce.
At issue are products marketed by Kagen's clinic such as Poly RW, Super Ragweed, Poly Grass and Super Grass. Kagen is a medical doctor.
So Kagen has been selling Super Grass without a license.
That's not good when a lawmaker is a lawbreaker.
...The FDA letter says that the products appear to be drugs as defined by federal law "because they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease." The agency cites as evidence an article published by Kagen in which he claimed to have safely used the vaccines in 55,000 injections in 500 allergy patients.
The letter does not make reference to any action it is contemplating against Kagen, but says that it is Kagen's responsibility to make sure products marketed by his firm are in compliance with federal laws and regulations.
Gee, do you think the FDA would allow me to make and distribute a drug product if I didn't comply with the law?
Do you think I would just get a little warning letter reminding me to stop breaking the law?
No chance.
After being told to cease and desist, Democrat Kagen announced that he will no longer be acting in violation of federal regulations.
WASHINGTON -- Rep. Steve Kagen, who recently turned over the daily operation of his four allergy clinics to his brother, says the clinics will no longer create certain products used in allergy shots for his patients.
Kagen's announcement, in a statement issued Tuesday, comes on the heels of last week's announcement by the Food and Drug Administration that the substances appear to be drugs regulated by the agency and, as such, require the clinic to file an "investigational new drug application."
In addition, the FDA said the shipment of those treatments for sale in at least 24 states requires the clinics to obtain an FDA biologics license. Kagen's clinics do not have a biologics license for interstate shipment of drugs, nor have they filed an investigational new drug application, according to an FDA letter dated Dec. 18 and released last week.
I wonder how much money Kagen made by marketing his Super Weed, in violation of federal law.
I would guess quite a bit.
Ignoring the law and government regulations isn't somthing to be proud of but it can be lucrative.
Kagen is probably not pleased that he got his wrist slapped by the FDA. His clientele probably aren't too happy either.
What will they do without their Super Weed?
Ah-choo!
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