FDA report says center’s ‘misbranded’ drugs not fake
Jan 14, 2013 at 10:09 PM
“Misbranded” cancer drugs a Johnson City doctor pleaded guilty to receiving in federal court in December were not fake, according to an FDA report released Monday by his attorney.
Mark D. Slagle, who represents Dr. William R. Kincaid, who was a partner in McLeod Cancer & Blood Center in Johnson City, said the 18 drugs collected from that business Feb. 16 by the government were not counterfeit nor diluted and, in fact, contained the proper active ingredients.
He cited a 10-page report from the FDA created Dec. 17 that he received by email from the Department of Justice on Jan. 9.
The drugs collected by the government were obtained by McLeod from Montana Health Care, which was a subsidiary of Canada-based Quality Specialty Products.
Kincaid appeared in federal court in Greeneville on Dec. 11 and pleaded guilty to “receiving in interstate commerce a misbranded drug with intent to defraud or mislead.”
According to information in the plea agreement, the federal government claims McLeod purchased $2 million worth of cancer medications from QSP, but the drugs were not processed through an FDA-approved supplier.
The drugs cost less than the clinic was paying from FDA-approved suppliers in the U.S. and a decision was made by Kincaid, Dr. Ray Lamb and Dr. Charles Famoyin for the business manager, Michael Combs, to order the drugs in September 2007.
Later that year and in 2008, nurses raised concerns about the medications with foreign language on the labels. Shipments from QSP stopped but were resumed in 2009 with the drugs going to a storage business in which Kincaid had part ownership. These drugs were then mingled into the FDA-approved drugs at the cancer clinic.
After his plea hearing, Kincaid was released on $20,000 bond.
A sentencing hearing was set for June 3. Kincaid, 67, faces up to three years in prison, a fine up to $250,000, supervised release up to a year and probation up to five years.
Combs was charged during the investigation, which began in February, and pleaded guilty to one count of receiving misbranded drugs. He faces up to a year in prison and a $100,000 fine, and a possible five-year probation term. Combs is scheduled for sentencing April 1.