FDA Faults Congressman's Allergy Product

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.

In a statement issued to The Associated Press, Kagen said: "Like other allergy clinics, the Kagen Allergy Clinic compounds allergen injections for patients who suffer from allergy and asthma symptoms. The FDA and I are discussing this important compounding process, and how best to treat affected patients safely and effectively, as we have been for the past 25 years."

A spokesman for Kagen declined to elaborate.

Compounding generally involves preparing a customized medication for an individual patient with a doctor's prescription, according to the FDA. While that is legal, compounding operations run afoul of the FDA and federal law when they produce drugs on a scale more consistent with that of drug manufacturers than, say, that of retail pharmacies.

Giving patients allergy shots can increase their immunity to allergens, the substances that trigger allergy symptoms, and reduce allergy symptoms, according to the American Academy of Allergy, Asthma & Immunology.

Kagen owns allergy clinics in the Wisconsin cities of Appleton, Green Bay, Oshkosh and Fond du Lac. Kagen loaned his campaign more than $2.5 million in his congressional campaign last year, accounting for most of the money raised for his candidacy.

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.

FDA spokesman Doug Arbesfeld had no immediate comment.

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Associated Press writer Andrew Bridges contributed to this story.